Suffering In Silence From A Medical Device - Surgical Mesh (Part 1)

Jane,

It is a wonderful service you are providing, by helping me and others get the word out about this horrid device. I will look forward to parts 2 and 3 of the story.

I have the utmost respect for you!

If you or a loved one has been injured by a medical device, please sign the Medical Device Safety Act Petition which can be found at More ...
The Medical Device Safety Act S540/HR1346 can be viewed on More ... We need to stand together to get this very important bill passed in Congress and the Senate to protect innocent victims of faulty medical devices.

I had this procedure done although I do not know what type of mesh was used. I was never told of these complications. So far, all is good, but now I have to hope it stays that way.

I had a SUI problem and needed Dr's help. He tested me and said he could fix my leakage. With a simple surgery by lifting my bladder with some type of new mesh device that was state of the art. With little or no complications. My girlfriend told me tonight that a friend of hers has a mesh device put in for a hernia problem. And now theres some kind of problem with the mesh.
So I thought I'd take a look around the internet to see if anyone won else had any problems with
the tvt mesh I had inplanted in my body. I'm not
sure what manufactor the doc used. But things seemed alright at first, no more leaking, that
great. But slowly I'm beginning to notice problems. Especially the last couple of months
I've had an awfull order after I've urinated and
pain a blotting in my abdomen. Now that I've read
your article I'm a little concerned. My procedure was done between 2004 & 2006. I havent had a period for 5yrs. and this summer I had the weirdes think happen to me on a camping trip. Severe pain and I passed a huge amount of blood vaginally, like something inside of me exploded.
Went to my pcp, he did a pelvic nothing wrong and then sent me for a ultrasound, nothing. Exceopt the tech said she saw the sling they put in to lift my bladder. I'm not sure if I have a problem with the sling or it was just a fluke. Any advice for me would be appreciated. Medical or Legal

Well, I sure hope that this story about this lovely lady gets through to every one and that no one has to suffer ever again with this evil tvt mesh,I myself have suffered since aug 2007 and believe me it has been a hard road,my story started in 2007 when I was told that a little procedure would do wonders for me,I suffered from SUI,a simple surgery (day surgery i was told)in out back to normal in no time.WRONG ,,my nightmare started,first my bladder was ruptured,lost a lot of blood,was catherised for almost a week ,pain was unreal then when you think every thing is going to be a bit better blood clots form in your bladder ,they dont move well!!! then there is irragation of the bladder,,,(how much fun is that????)some one using a bag of water to flush and then suck out blood clots using a siringe,quiet painful to say the least,guess what its not over yet!!!infection,,,yes infection!!!more pills and injections in the stomach,,Finally to be released after a week ,got home and ,,,another infection,,,back and admitted again for days!!!that was a year and a half ago since then there has been nerve blocks done in the( OR)which I had to be sedated, 2 surgeries (PARTICAL REMOVALS),scopes(MORE SEDATION) tests upon tests I feel so upset at the world not just at the makers of this mesh,,so please pay attention to what this mesh has done to 1000"S of people,,help try to get it taken off of the market before someone else gets hurt,,,,God Bless ,,,,mom1965

I think that too many medicines and too many medical procedures are being offered to the unsuspecting, trusting public without thorough and efficient testing. That means that many new products are essentially being tested on folks without enough time passing to study the long term effects. This can cause much undue hardship on patients, while filling the coffers of drug companies. Shame on them!

In the case of Suzanne McClain, she trusted the FDA (Federal Drug Administration) when they sanctioned the use of Surgical Mesh. Now, as so many men and women are openly acknowleding the harm that this device has caused them, it is the abslolute responsibility of the FDA to reexamine the harmfulness of this device and remove it from the market.

Suzanne McClain also trusted her doctor. She believed him when he said implanting this mesh was an "easy fix." And why shouldn't she have? She lives in America, a leading nation among nations . . . and, we have to be able to trust our doctors.

To not have the risks clearly delineated by her physician was unconscionable on his part. Maybe he was duped by the drug companies; but it is his obligation to know. It is his responsibility to provide only the best care for his patients. Afterall he took the Hippocratic Oath--"Above all, do no harm."

I sincerely hope that doctors and drug companies and more importantly the FDA will be more conscientious when providing medical care to their trusting public.

Just as in any profession, there are good, concerned practitioners and there are those who feign concern but really want to make an easy buck. Doctors are no different. The surgeon who implanted the TVT Mesh should have been aware and told Ms. McClain of the downside of using a synthetic sling, even though it is cheaper and easier. There is no excuse for this incompetence. Knowledge takes work. It’s too easy to believe the company line. Everyone in the wrong was trying to make easy money; and the FDA, supposedly the watchdog for the public, totally failed in allowing this product to come to market. Bravo to Ms. McClain and other women for having the courage to speak out about the problem with this product and the procedure. This needs to be brought to light by government and the courts.

I know Suzanne McClain personally, as she is my little sister. I know too, what the last nine months has been like for her since finding out about the mesh eroding inside her.

The day she found out her whole world turned upside down. In the initial stages, she became very depressed, then she became very angry. She told our family that two of the five doctors she had seen told her that removing the entire device could be complicated and delicate, having to be dissected from her tissues, and one of those doctors even told her it could be a dangerous surgery. Both doctors also told her that it could take multiple surgeries to remove. Suzanne was very scared, and I was scared for her.

But knowing my sister as I do, I knew it wouldn't be long before she got out of her depression, and started addressing what had been done to her to the best of her ability. She's quite knowledgeable about research and that's where she began. She has told me that she spent nearly nine months, from 3-4 hours a day researching everything she could about Ethicon's Tension Free Transvaginal Taping System, in other words, the polypropylene mesh that was implanted inside her. She was able to ascertain that this product was a petroleum-based product. She is also trying her best to help other mesh victims by posting on a blog on Yahoo:

More ...

This blog was created on August 12, 2007 by another mesh victim, and a little more than a year and a half later, there are already 756 posts to this blog and it is 38 pages long. She has also become quite proficient in researching the FDA's MAUDE Database, which is how she found out there were more than 660 adverse events on file prior to her initial surgery in 2004, of which her doctor did not make her aware. My sister recently told me that her latest search of the MAUDE Database revealed nearly thirteen hundred adverse events in reference to this Tension Free mesh.

Suzanne and I talk quite frequently, and she explained the FDA’s 510K process to me. She said the manufacturer only had to show substantial equivalency to an existing product already on the market which basically does the same thing, and the FDA generally approves these devices within 90 days. Clinical trials are not required for class II devices, which is what the device implanted in her is.

Suzanne told me that Ethicon used the ProteGen Sling as it’s predicate device citing substantial equivalence, and gained approval on January 28, 1998 under FDA Approval number K974098. Twelve months later on January 22, 1999, the manufacturer of the ProteGen Sling sent the FDA a letter stating that their product did not appear function as intended, and was associated with a higher than expected rate of erosion and dehiscence. This product was officially recalled via a firm initiated recall, and this information can be found on the FDA Enforcement Report for March 17, 1999.

It is ludicrous that it took the FDA nearly two months after receiving this letter to pull the device from the market, and even more disgraceful that they left other “substantially equivalent” devices that had used the ProteGen Sling to gain approval on the market to harm people.

I know that Suzanne along with six mesh victims who belong to the same patient advocacy group she joined shortly after finding out about her situation, has asked for a Congressional Hearing to address the 510K process, and to address why petroleum-based surgical mesh products are still on the market to harm people.

I am so proud of my little sister, and I hope that she and the others are successful in getting this hearing so they can speak on behalf of the masses who are suffering because of the greed of these manufacturers who knowingly are leaving their products on the market to harm people.

It's shameful that people have to go through the suffering that Suzanne and many others have gone through. However, sadly what has been done is done. Now she is trying to get the attention of those on Capital hill to listen and investigate, and more importantly, take action on this and many other problems that falls under the control of FDA. THIS PRODUCT SHOULD BE REMOVED AND DECLARED IMPROPER TO USE BY THE MEDICAL DOCTORS.

With all the current technology and medical advances - HOW could something like this happen! HOW could this keep happening. Because of what my friend, Suzanne is going through, I will not use that doctor - or this procedure and I will (and already have) warn all friends, coworkers, and family. Because Suzanne is networking her story - millions (I pray) of women equip themselves with the necessary knowledge to make informed medical decisions.

I have a hard time understanding this. We live in a country that is supposed to have the best medical care. How can our doctors, our government, the drug companies and all the rest of those who approve of unsafe drugs and such things as this mesh sleep as night and live with themselves during the day. There has to be an accountability.

I spent 3 months in Russia and I've seen the medical care there. I thought they were a little backward. I thought that we'd be safe in America but when you read of things such as what Suzanne and many others are experiencing, I wonder. Perhaps we're not as safe as we think.

Who would ever dream that you go to your doctor whom you trust (because if you can't trust your doctor, you're in big trouble) and end up with bigger problems than you began with. You believe that they are well informed and are only looking out for your well being. And then you find that they don't know all they act like they know. And you pay the price, sometimes for the rest of your life.

I believe that the women that Suzanne has been in touch with who are also suffering need to step up and be recognized. Their families need to speak out. There should be nothing embarrassing about acknowledging that you have this problem. Problems become bigger and continue to affect others when people won't do anything...when they suffer in silence. Somebody has to stop the irresponsibility. The voice of one person is not very loud on it's own but when it's joined with many others it can become a deafening roar.

I believe too that there should be an investigation. These devices should not be permitted to be used until there is an honest evaluation...and not by the companies that produce them. We need our lawmakers to step up and protect us from those who take advantage of us. This is part of what they are elected to do.

Suzanne:
I'm so proud of you for attempting to educate people about this procedure even before it takes place. While you and I had the same doctor perform the procedure, I have not had any problems in almost the last eight years. To this date, I do not know which manufacturer made the device that was used for me. AFter reading the symptoms from you and others, I feel very fortunate that I made the right decision. Luckily I do not experience the health issues you are but I understand what you must be going through. It could have very easily been me having the same medical problems now and researching to find another doctor to correct the procedure.

I would be happy to assist you in any way to help get the word out to others considering this procedure. One should not go blindly into this surgery without sufficient background information. Once this is researched, an informed decision can be made as to whether or not the procedure should take place. From my own experience, had I read about any of these complications, I would have been better prepared to make a decision. In the long run, my decision to have the surgery has definitely given me a better quality of life; one that I would recommend to others with SUI. Now, I would certainly recommend someone doing their own research to discover the pros and cons of the tvt procedure.

Hello. I think that this device should never have reached the market place. I doubt if the testing done was even worthwhile because of the tragic results that came about here. I think this is another case of wanting to get a new product out there where money was and is the principle motive behind it. It's to everyone's advantage to have new ideas and inventions, but without the proper motives and safeguards behind them, there will always be abnormal risks to people who entrust themselves to who they believe are acting with their best interests and concerns in mind. So, this really is a case of greed taking over-rushing to get it out there-all in the name of a BETTER way to do something. Come on now-its time to step up and be accountable. Its time to get these devices OFF the market and ante up to the trusting folks who were duped into believing that this was a GOOD thing to use.

I too wish I had seen additional information prior to having surgical mesh used in Feb. 2003. I knew immediately after the surgery that something was wrong and no one would acknowledge that I knew my body wasn't right. I didn't have an infection so I guess they all thought it was in my head. After months of asking for help, I was sent to a specialist. It has been a long painful search for relief. I have spent more time in physical therapy than I can even remember. I'm left with pelvic floor dysfunction and pudendal neuralgia. The physical and emotional damage is difficult. The loss of an active sex life has to be mentioned...as well as lost wages from missed work. I wish doctors really discussed with patients the risk they are taking and all of their options. What was supposed to be a simple procedure has turned out to be an ongoing nightmare.

i was also taken in by this new way of doing the bladder (pubovaginal sling procedure tvt/sparc).i was told it is a great way to go about doing it .takes only 20 minutes in surgery and on your on your way home 1 hour after recovery .hey who wouldnt go for that ,knowing that you can return to work a few days after ,but not to any heavy lifting up to 4 weeks ,which is the normal thing after any surgery 4-6 weeks .i was also told (by my doctor )that he hasnt had any patients that were dis-satisfied .i read the pamphlet that he gave me and it all sounded good to me .i just wanted all this leakage to be over with .i couldnt wait for the time to come to get this surgery done and all my troubles would be over .like going to heaven ,wouldnt you think .
instead of going to heaven i went the other way .what a night mare since day one ,i never recovered from surgery april 21 2008 .tried going back to work ,that lasted only one week and couldnt take the pain anymore .went back to my doctor telling him things just dont feel right and he did admit that there could have been some nerve damage done there or where the mesh is rubbing the bone with movement .he scheduled app. to remove part of the mesh in nov 2008 ,just 7 monthes after putting it in and i had to cancel do to this awful rash i broke out in all over my body from head to toe (not sure if it is related to the mesh )i had to be put on methotrexate ,because i was a mess .
feb 2 nd 2009 i went ahead and had surgery to remove some of the mesh .i am 8 weeks post op and still no better .back and forth to emerge with infections that as now finally cleared up .the pain is still there and i have to wear loose clothing because i cant have anything touching my groin area .saw my doctor again and now he tells me he is only 10 % into doing this kind of surgery .i have to see another specialist now to try and fix this mess .
my only wish is , i hope that they would soon put a stop to this tvt/sparc surgery before other woman are injured .
i still have a long road ahead of me before i get back to normal ,if there is such a thing ,being normal after tvt mesh .
i am from canada and reading the post i noticed ,that there is a lot from the states ,i am sure there is alot from canada also that just didnt come forward yet ,the law is differant in the states then in canada
but i wish all of you woman that have been injured ,the best of luck in the near future .

Over a year ago I began searching for all the information I could find about mesh for vaginal wall prolapse. I don't know why, but all I found was the propaganda and I had the surgery done last April. In addition to having the graphs added for vaginal support, my surgeon advised me to have a TVT procedure done, as well. I recovered slowly, had a good bit of pain at first but it seemed to gradually improve. At some point, however, it stopped improving and worsened. My surgeon acknowledged some of my symptoms and pain but ignored other troubling symptoms. When I began doing my own research, I found Ms. McClain's story. Thank God! It has helped restore my sanity and helped me realize that I needed to do something now, and not sit around and wait for something to heal that is not going to heal but likely cause greater harm the longer I leave it in my body.I do not feel that the risks for these types of complications were sufficiently explained to me. In fact, I feel I was overly sold a glossy and rosey picture. If I had read Ms. McClain's story a year ago, I am most certain that I would have made a less radical choice.

Until hearing Suzanne's story, I did not know that products could be placed on the market without proper testing. I just assumed that all products that are FDA approved were tested. Bad assumption obviously.

I hope that Capitol Hill will listen to these victims and reconsider their process for putting products on the market.

Thank you Wayne Parsons for your support in this ongoing petition for the Medical Device Safety Act - 2009 - S540/HR1346. Both Congress and the Senate have been alerted to view this Petition as an ongoing plea from injured parties and their loved ones. They have been encouraged to support this bill and become co-sponsors in order for this very important legislation to quickly pass through Committee. Again, this petition can be found at: More ...
Thank you for joining in our efforts for bringing this to The Congress and The Senate's attention in asking for their support in passing this urgent piece of legislation. Together, we can conquer, alone, we cannot.

It is becoming increasingly obvious to me that the government agencies which we fund to protect us (especially the FDA) are falling down on the job. Makes me wonder if the people running them are in the pockets of the companies they are scrutinizing!
We need to get these agencies back on track to save us from inadequately tested drugs, medical devices, and food.
Come on, Congress, get moving!

Thank you for alerting people to the mesh problem. I am just getting over a hernia surgery and will be asking my surgeon lots of questions tomorrow in the follow-up appointment!

I want to thank strong people like Suzanne for being strong and standing up for the rights of others as well as herself. I was faced with making the decision of living with SUI or having the sling. My doctor at that time told me that it would be a revolutionary new product (a mesh fabric) that is surgically placed to support the bladder. I chose not to have the procedure done and today I am so thankful that I did.
My #1 reason was "a revolutionary NEW product". I have a very firm belief that I do not use any NEW medical products of any kind until they have been on the market and public tested for at least 5 years.
My #2 reason was I had had many many medical tests done 20 years previous because of severe kidney infections and had been told I have a tube from the kidney to the bladder that is not in the correct position and is too small. I was concerned that moving the bladder into a different postion would interfer with that situation. The doctor did not seem to think that would be an important issue to concern myself with. I would rather have the SUI than the constant kidney infections.
So, having read Suzanne's story I am very thankful that I am not one of the victums of modern medicine.
Hopefull Congress will listen and take immediate positive action. I also hope they will truly do something about the way the FDA approves items submitted by Pharmacutical companies. They need someother way of researching new procedures, products and medications. Determining the safety of something should NOT be based on the company's (who will be the one to profit)own research findings. The do not even supervise this research. The company does the research and reports thier findings to the FDA. So, it seems it is based on the "Honor System". I for one do not trust the honor of the large money hungry corporations.

Suzanne,

Thank you for sharing your very personal story. Like you, I am a member of Truth in Medicine.

I had Gynecare Gynemesh PS made by Ethicon, Inc. placed in me on January 26, 2006 and developed a post-operative hematoma and it was surgically removed on February 1, 2006. Within several weeks, I developed mesh erosion. I've had two separate surgical procedures, requiring overnight hospital stays to have the mesh removed from the cystocele site. I still have the rectocele mesh and I believe I'm experiencing a foreign body reaction to it.

I did not know that my doctor was implanting a permanent medical device in me. I was told that the procedure is "A walk in the park and a permanent fix." Unlike a lot of women, I did not have any urinary incontinence problems. I just happened to go to a new Doctor that just opened up a new practice. I was seeing him for HRT. He recommended an unnecessary surgical procedure and I fell for his unethical sales pitch. If you're reading this and thinking why would someone let a doctor perform a surgical procedure when she's not having any problems, trust me, I'm still asking myself this same question. It's a very lucrative business for the doctor, manufacturer, hospital and sales representatives and I was used as a guinea pig without my knowledge. Not only are the doctor's and hospital's making money for the initial surgery, but they are also making money when the patient has to have repeated surgeries to have the medical device removed.

A lot of women are single mother's, some women do not have health insurance and are having to suffer with the physical debilitation of the device each day, the recuperative period is not a walk in the park as we're told and it's a very long recovery period. In addition, most women are left with permanent pain and suffering and disabilities.

Everyone who has health insurance should be notifying your insurance company to place them on notice of how their being ripped off by doctor's. It's not just the patient that feels a negative impact from this type of surgical procedure, but it also has a huge impact on our health care system and our health insurance premiums. Women need to be educated about non-surgical alternative treatments before undergoing a very invasive surgical procedure that is not supported by any proven scientific data that shows that its safe and effective.

Most of the doctor's receive their training in a Hotel Conference room on a weekend and may be trained by a sales rep from the manufacturer of the medical device.

I did not do any research on this subject until after I was aware that I had a permanent device implanted in me. What I read scared me too death. I knew after reading several other stories that I was probably in for the battle of my life. Three year's later and I'm still sick from the mesh.

Suzanne, I did meet with several FDA Agent's in Atlanta on February 22, 2007 and provided them with a twenty-seven page letter letting them know just how badly I was harmed from Ethicon's medical device, how dangerous the synthetic mesh is, how broken their adverse event reporting system is, they are not protecting the public from these harmful medical devices, they are aware of the harm, it's their job to protect the general public, etc. They did turn my complaint over to their New Jersey office and the FDA conducted a six day on-site investigation into Ethicon. Ethicon was cited with a FDA-843 Observation (I think this is the name of the report). I do have a copy of the investigative report.

I sent an e-mail to several of the Doctor's that are over the division that monitor's the adverse event reports, and told them how angry and outraged I felt when I turned on my TV one evening in July 2007 and saw about a half dozen FDA Agents holding a press conference due to the fact they were issuing a recall on dog food because three dogs had died. I asked them if a dog's life was more important than a human's life? I received an e-mail response back that the mesh was a complex situation.

Some people may have been thrilled that the FDA issued a Public Health Notification last October on the serious complications in association with synthetic mesh materials. However, I am not at all pleased with their notification. After they issued this notification, I spent about a week gathering more data from their own database, copying and pasting almost all the adverse events where the person had a serious complication, disability, life-threatening event, hospitalization, etc. so they could pass the information onto the medical mesh group that is suppose to be investigating these issues.

The FDA sent the notification to hospitals and doctor's and they already know about the serious complications in association with mesh use. It's the general public that's not aware of the serious complications and the failure of the FDA to choose not to issue a general public notice is criminal in my opinion. The general public needs to be educated about these serious issues with synthetic mesh as soon as possible. Just read the FDA's database on he adverse event reporting system and you will see for yourself that more women have died this year from these procedures. Do you think the FDA is protecting us? Do you think the FDA should be held liable for these deaths?

Back in 2006, I was a rookie and did not know anything about how the FDA operates. It was through my own due diligence that I educated myself (after the fact) about the role the FDA has in protecting the general public. I had no idea that an adverse event reporting system existed with the FDA. Again, I was a rookie and I was overwhelmed with dealing with all of my health issues and I was determined to find out why I was still ill from this surgery. My many, many doctor's did not have any answers for me and I was left to begin this journey on my own. I felt like the lone ranger and I had no idea that other people were experiencing the same problems that I was experiencing, getting little to no help from their health care providers and we were left to deal with serious complications on our own. It has been three long year's of frustration for me since my first surgery and two year's since I met with the FDA and we are no more closer to getting answers from the FDA than we were two years ago.

I cannot turn the clock back and get my health back to where I was three years ago. However, I can choose to be proactive and take a stand with thousands of other mesh victims and fight for our rights to be protected by our Government Official's. The FDA is broken and it's going to take ten year's for their system to get fixed. This information came out of their own report over three years ago. We cannot wait until they get a workable database monitoring system of adverse event reports because each day that goes by is another day that some innocent person is being harmed by a medical device that should have never been on the market in the first place. These medical device companies have to pay the FDA an upfront user fee to get their medical device to the market and this money is supposed to be used by the FDA for Post Market Surveillance of this product and it's not happening. I wonder what the FDA is using this money for??

I am just as passionate about this subject as a lot of other people are who have been harmed and I will not stop until the FDA issues a recall on synthetic mesh medical devices.

What Suzanne and her brother has said about the 510(k) premarket approval on these medical devices is true. I have documents where some medical devices have been recalled then company ABC submits a new 510(k) application for their new ABC medical device and they compare it to a predicate medical device that has been recalled and the FDA approves the medical device even though it is going to be used for the same intended purpose and has the same material that the recalled product had. The product was recalled because it posed serious health risk to the general public, but the FDA turns right around and approves a new "named" product to be used for the same intended purpose. What's wrong with this picture??

I can't stop when I start talking or writing about my experience and what I've learned since this medical device was implanted in me. I will continue my patient advocacy work on this subject. Everyone that has been harmed needs to do their part in educating their loved ones and friends and bring this subject to the forefront.

I have never been so critical of a Government Agency, but the FDA is not protecting the general public. If we cannot rely upon the FDA to protect us from these harmful medical devices and the manufacturer's who are making billions of dollars off of these harmful products then who can we rely upon to protect us?

Suzanne and I work for the same employer, and I, like Suzanne, had the TVT procedure by the same doctor, though I had mine at the same time as my ob-gyn completed a rectocele repair. I now have TWO meshes (plus one for an earlier abdominal hernia repair; no problems there), and I have problems very similar to Suzanne's. I am also having problems with the ob-gyn mesh.

I am 41 years old. I had the sling procedure after the birth of my 3rd child to deal with the leaking of urine with movement. I was 38 at the time, a teacher and on my feet constantly, and chasing after three young children. I was told that this would be wonderful, and that I wouldn't have to deal with "pads" on a daily basis. I've never been totally pain free since, or enjoyed sexual activity with my husband after this procedure.

I developed severe pain, and foul smell two months after my initial surgery. Went to my DR. and was told that I had a quarter size opening that the mesh had come through into my vagina. He had to remove the mesh and I was on premrine(sp.?) and meds to clear the infection that had develped. I was also made to feel that I had done something to open the area, and also, he hadn't seen this in other patients. It scared me. I trusted him.

Well, pain continued and was told that my vagina had lost some of its elastic ability and that is why I hurt during intercourse. Why didn't I start searching at this time for answers? I just kept doing what I was told, and a year later, I opened up again and the mesh came through my vaginal wall again. They had to go in and remove more mesh, and was told that the area around the mesh was infected and that what was causing the pain and odor. More meds and doctors visits followed. Was told that if it happened again, they would have to go in and do repair of my vaginal lining by moving healthy tissue over the weakened area.

I continued to hurt, just thought that it was due to age at 40. Last March, '08, I started developing the severe pain, a shooting pain that would go through my pelvic cavity with movement, and the all too familiar smell that I associated with the vaginal erosions. I went to my Dr. and he did not find any mesh or opening, was told that I just had a bacterial infection. This is the start of my last series of problems. I Stayed on meds, creams, and pills. I also visited the Dr. on many instances for pain, and told him I think it is the mesh. Was told that it is not the mesh, it's age, just keep using the premrine.

I went again to Dr. in July '08, thinking that I had a bladder infection and was told that I was pregnant. Did ultrasound, and heartbeat was present and I was around 9-11 weeks along. I had no symptems of pregnancy, I had been dealing with pain,smell, recurrent bacterial infections,spotting, at the time of this.

I was scheduled for another ultrasound to determine exact date in two weeks time. Still dealing with all my other problems, and wondering how pregnancy would do with the sling implant....

I went back for ultrasound after two weeks, and no heartbeat. I lost the pregnancy. I started researching, and bacterial infections can be linked to misscarry and preterm births. So back to my original problems. I have been on Meds and had so many Dr.'s visits in the past year. I also started to have research bacterial infections. I was told that the cause could be diet, or other things. I was ready to start testing in other areas to find out why I couldn't get over the infection. I really thought that I could have a serious disease due to my declining health, and still, I was told that it was not the mesh, eventhough, I asked on every visit. Depression set in. I've never misscarried before, and I just didn't have any answers.

I finally started looking into infections and mesh and found out of the numerous complications that women have suffered. I feel so stupid that I trusted my Dr. so completely, and did not look into this earlier with my problems. I immediately found a specialist and was told that I am reacting to the mesh as a foreign body, and I would not heal until it is removed. He also found the mesh erosion high in the vaginal cavity, and when the spot was touched, It was the exact area that I have been feeling severe pain, and eventhough it hurt very bad during the examination, I was so relieved that he found what was causing the infection and pain. He talked with me for a long time, and immediately schedule me for removal of the mesh and as much of the tape/sling that he can safely remove.

I go tomorrow for my pre-op visit, and will have the surgery next week. I am very scared, but feel like I have finally found help.
I believe that I should have been told of the complications of the sling from the original Dr., and I have a lot of anger over this.

I will do whatever I can so that this will not happen to anyone else. The mesh/sling surgery has made the last four years of my life very hard, and I hope all those suffering will be able to find help. I am so grateful for these sites, and the research of Suzanne. I am, however, very sorry that you have suffered due to this procedure. Please let me know how I can help.

Jane and Suzanne,

Thank you for bringing this story to life. I am very saddened by the stories I am reading. More should be done to prevent this from occurring to other women and this is one step in the right direction! It is scary to think Suzanne could not find information earlier but I feel this blog moves in the right direction for more women to learn more about this procedure. I am glad that, as painful as it must have been, that Suzanne broke the silence. If we all shouted with her maybe we can make positive changes for women's health.

I write in support of my youngest daughter, whom this story was written about. My hope is that her story will generate national attention, and that in doing so she will be allowed to speak on behalf of the masses that have been harmed by this medical device.

Suzanne found out that she had suffered injuries by the medical device mentioned in this article in June of 2008, and she was absolutely devastated by the knowledge of this. Since then, she has shown tremendous resilience in fighting to get petroleum-based mesh products used for surgery off the market, and to facilitate a change in the way the FDA approves medical devices.

Suzanne has always stood on principle, and she is not afraid to fight the big fight. We have talked many times about how difficult taking on the Food and Drug Administration and the Pharmaceutical Companies will be, but because Suzanne is a woman who lives her life based on principle, she has told me that she is prepared to stay in this for the long haul.

She, along with six members of the patient advocacy group that she joined after finding out of her problem has repeatedly asked for a Joint Congressional Hearing to address the topics of the FDA’s approval process and the dangers of surgical mesh, yet their multiple requests seem to have fallen on deaf ears. I personally know she has written many letters to our elected officials making this request, but to date has received only on response from a Representative in her home state, Mississippi, who gave her the names of two people in Washington to contact: one of which she had already contacted. She told me too, of letters she has written to the FDA and Center for Devices and Radiological Health, (CDRH) yet only one of these government agencies responded, and it was basically in the form of a form letter.

Suzanne told me that she feels if her story were to gain national media attention, the likelihood of her and others being granted this Joint Congressional Hearing will improve dramatically. This type of forum would allow my daughter to speak on behalf of many who don’t know what do when faced with a problem such as she is facing now. She not only wants justice for herself, but for all people who are standing in the same shoes she is wearing.

I am probably biased, but I think my daughter is a really incredible woman, and I am very proud of her.

I also wish to thank Ms. Jane Akre for believing in her, and for recognizing the problems being created by improperly approved medical devices.

Suzanne,

My thoughts and prayers are with you on this issue. It is appalling that our government allows for this to happen to people they were formed to protect. By rushing products in such a cavalier fashion - they are condemning the public to unfathomable pain - both mentally and physically. The short "studies" they conduct and pass on to us is criminal, when in actuality they are using the public to further their studies and countless families are injured in the process. Regardless of the FDA's lack of proper investigation prior to approval - no doctor should be allowed to conduct procedures without divulging all information - pros and cons. When are we going to begin to practice preventative medicine in this country - perhaps after we are all bankrupt and no one can afford medical assistance. How many instances of a drug being released without proper studies quickly followed by a influx of lawsuit commercials encouraging us to sue for the loss of a loved one must occur before we realize the flaw in the system?

Good Luck Suzanne.

In my Mother, Til’s comment, she addressed various entities and people that I have contacted, and how most have chose not to respond, or to respond in a form letter type response. It is a disgrace that we elect these people to office to be our voice, yet when we need our voices heard, no matter how loud we shout, they seem to turn a deaf ear.

The following is a letter I received from Medwatch, a division of the FDA on July 29, 2008:

From: medwatchcomments@cder.fda.gov
The above "From:" address may be forged.
Save Address Reminder
To: editwrtr@...
Subject: Thank you for your submission
Date: Tuesday, July 29, 2008 5:03:13 AM [View Source]

Dear Reporter:

Thank you for submitting your report to MedWatch, The FDA Safety Information and
Adverse Event Reporting Program.

This acknowledgement confirms that your report was received. Reports are added
to a postmarketing safety database with similar reports and reviewed by the
FDA’s postmarketing safety staff. Voluntary reports are essential for
ensuring the continued safety of FDA-regulated products. One or two
well-documented case reports may provide an early signal of unexpected problems
and lead to additional evaluation. This may result in FDA regulatory actions
that improve the safety of the products used in patient care each day.

You might be contacted by an FDA staff member if additional information on your
report is needed.

Again, thank you for taking the time to submit your report.

Sincerely yours,

MedWatch

Subscribe to the MedWatch E-list, More ... , to receive
e-mail safety alerts about FDA regulated medical products.

Here is my response to the MedWatch Letter.

I waited five weeks, and I emailed them back:

From: editwrtr@...
To: medwatchcomments@cder.fda.gov
Subject: “One or two well-documented case reports. . .)
Date: Tuesday, September 9, 2008 11:49:06 PM High Priority

September 9, 2008

Medwatch:

Your recent email to me of July 29, 2008 specifically states that "One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day." I am fully aware of dozens of reports being filed with you regarding the Gynecare TVT Device, model/catalog number 810041B, and polypropylene surgical meshes in general, yet there is no indication that anything is being done about it. How many more people must be harmed by these types of devices, before you take us seriously?

My life has been destroyed by this product, and because the pharmaceutical companies appear to be in bed with the Supreme Court Justices, (ruling of February 20, 2008) I have no recourse to hold anyone accountable. I am an AMERICAN CITIZEN, harmed by a device that the FDA deemed as safe many years ago, and still deems as a safe product today; all the while knowing that patients have been filing, and are still filing adverse event reports saying how they were harmed by this and other polypropylene products.

It doesn't take a rocket scientist to figure out that a medical device, made of polypropylene, a very abrasive fabric, having holes throughout, so that tissues can intertwine within the fabric, and implanted in the human body would erode away healthy tissues. My doctor showed me a Gynecare TVT sling the last time I was in his office, and when he pulled on the end pieces, many small pieces of the mesh were falling onto his table top. He then wrapped it around his finger and rubbed it on my hand. This is a very abrasive material. He said that he has treated men who have racing strips on their penises from being scratched by this device, after having intercourse with a woman who is experiencing erosion through the vaginal wall. This device mimics a cheese grater.

Tell me, do you REALLY believe this is safe? I imagine, had it been your wife, mother, grandmother, sister or daughter harmed by this device, heads would already have been rolling. So, please, send them all out to have this procedure done immediately, so that when they start experiencing complications, those of us who have already been harmed can get some relief in the form of a recall!

It is your responsibility to keep victims to a minimum, and each day that this product stays on the market, more women are subjected to vaginal erosion, bladder erosion, and nerve damage. I urge you, please take your responsibility seriously, and remove this product from the market. For that matter, if you were to remove all surgical mesh devices made of polypropylene from the market, you would be doing a world of justice, as these devices all seem to share the same characteristics when implanted in the human body.

Under the federal disclosure act, I would like copies of the clinical studies, if any, that were performed using this device prior to FDA approval, and any other documents and/or letters the FDA has pertaining to this device.

Respectfully yours,

Suzanne McClain
editwrtr@...

** Note - Believe it or not, I never heard back from them in response to this letter, nor have I received copies of the clinical studies, documents or letters that I requested..

Hi Suzanne,

I live in the UK. Well done for posting this article and to bring awareness to the immense suffering that is effecting many people worldwide from this dreadful TVT sling surgery.

When I was first told about this medical device back in 2005 my consultant said it is now the standard treatment for stress incontinance, a simple procedure with an overnight stay in hospital, I trusted his words and he made it sound like the best thing since sliced bread! I will never forget him saying to me before I left my consultation and I quote "Lorraine you will be a new woman" words that will ring in my ears forever!

Briefly my story is..

I went into hospital October 2005, this is basically what happened to me. I went in to have the TVT medical device implanted along with a marina coil, when I came around from the anesthetic I coughed so badly I thought my lungs were going to burst, the next morning I was feeling very weak, had an xray and showed several blood clots on the lungs with a collapsed right lung, (Pulmonary Embolis) I was given treatment with heparin and warfarin, after several months, I had and still do suffer with continuous bleeding, very bad monthlys now and I mean flooding, really bad, I was in and out of hospital for months after surgery, numourous appointments for blood tests, MRI's, CT Scans, you name it I had it done, eventually I was diagnosed with diabetes type 2 and Myasthenia Gravis throughout the first couple of years, then in July 2008 I found I had tape erosion, the mesh has eroded through the midline urethra. To this day I am still fighting to get the right treatment.

I am now awaiting a cystoscopy to see exactly what is going on as the stress incontinance is back. I am sick to of it all, it has ruined my life to the extent I had no option but to find a new home, lost my career, my family life including my son's seeing their mother so ill and also my marriage is effected, although thank goodness I have a loving husband who is supportive and very kind.

I had no idea right from the start after surgery when all along it was the TVT Sling which could of caused the severe bleeding, instead they made me believe it was the marina coil which I had removed. I also want others to know tape erosion can happen from day one right up to 7 years later after implanting the TVT Device! that is what I am lead to believe after researching, so for all woman who have had it done, please keep regular checks that you do not have to suffer this mesh erosion complication.

I pray every single day for justice, to see this dreadful medical device taken off the market to help stop others from being harmed.

I am with you and for all the sufferers to see justice is done.

Lorraine UK

All too often we are at the mercy of the medical system and the practioners incharge of our life. It saddens me that this is so real, please stop the approval without FDA investigation.

I've never had the need for any operation involving this mesh technique and thanks to Suzanne I never will. Thanks for fighting the fight to make others aware of the potential dangers.

Donna

Kudos to Suzanne for launching this campaign against current medical device approval methods practiced by the FDA.
What a shock it was to learn that once a device is approved by the FDA for use in patients, ANY company that says they have manufactured a similar device with the same purpose automatically gets approval for sale and use.

THIS IS A LAW????? ARE YOU JOKING?????

It is a sad day when substandard devices are not only used in patient care but also surgically implanted in patients. It has to be unethical to continue to use these devices even after complaints have been files against their safety and efficacy.

Keep on fighting.

It is absolutely absurd that these mesh devices continue to be used in patients. Even after multiple people have had to have multiple surgeries to repair damaged and degrading mesh and formal complaints were made, the FDA allows this device to stay on the market?, and doctors choose to continue recommending its use? Sounds like someone is receiving some kind of kickback to promote this mesh. HMMMMM?

I just cant beleive that with all the medical advances that we have made, that there can still be products like this out there! I really hope that Mrs. Suzanne continues on with her cause and doesnt let the FDA and medical professionals get away with this.

I (like Krystil) am amazed and shocked that this device is still approved and allowed to be on the market.... and that women are still not being warned by their doctors. My mother's doctor recently told her that it was her only option and that there were no real complications to be concerned with. Thankfully I had heard about the troubles Suzanne was having and warned my mother against it... but that should have been her doctor's responsibility if this device is still on the market... and in my opinion it shouldn't be. There have to be safer ways to solve this problem.

Thank you for sharing your story Suzanne. You may have saved my mother from going thru the same thing.

Good luck. I know you will fight hard and bring even more light to this issue.

I can only imagine how scared Suzanne must have felt having to go back to her doctor knowing something was not normal and then the disgust she must have felt after he so casually told her she had "won the prize". What happened to good bed-side manners? These are the grand-mothers,mothers,sisters and daughters that are looking to their doctors for good advice. Doctors should not only be well informed themselves on the products they use, but inform their patients as well. It is only because of Suzanne's knowledge and skills of internet research that she has been able to find out as much about the products used and their manufactorers as she has. It has not been easy "public" information to find either. It is because of her sincere concern for others that Suzanne gets this information out there for others to read. Way to go Suzanne. Its women like you that are out there fighting for whats right that makes it better for everyone else.

It is hard to think about this happening but believable. I hope and pray that something can be done so that others do not have to experience something of the sort.My prayers go out to you and your family.

Please see Jane Akre's great new article, April 9, 2009: FDA - Unproven Medical Devices Must Show Safety

It is fabulous news that the FDA is requiring "manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type."

It is a great opportunity to get the FDA to remove Synthetic Surgical Mesh from the marketplace and stop its implantation into Human Beings...the purpose of Truth in Medicine.

Lana Keeton
Founder, Truth in Medicine
truthinmedicine@bellsouth.net 305-342-8002


FDA News
FOR IMMEDIATE RELEASE

April 8, 2009 Media Inquiries:
Peper Long, 301-796-4671
Consumer Inquiries:
888-INFO-FDA

FDA to Review Medical Devices Marketed Prior to 1976
Action Addresses GAO Recommendation
The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.
These 25 device types, which are listed in the Federal Register announcement posted today, were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976. That law authorized the FDA to review new medical devices. Today’s announcement is the first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accountability Office (GAO) in a January 2009 report to Congress.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses. Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices are marketed after submission of premarket notifications establishing their substantial equivalence to legally marketed devices that do not require premarket approval.
After Congress enacted the medical device law in 1976, the FDA classified these 25 devices types into Class III (premarket approval). Under the law, these devices were not immediately required to undergo the premarket approval process. The law required the FDA to issue a rule subjecting the devices to that requirement. Until that time, new devices within those device types have been cleared through the premarket notification process, in which the agency determines whether they are substantially equivalent to legally marketed devices not requiring premarket approval. Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.
“We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.”
As of 1994, there were approximately 149 Class III, pre-1976 types of medical devices that had not yet been subject to premarket approval. Since then, the FDA has made significant progress in reviewing and issuing new regulations for all but 27 of those device types, including the review of 55 types since January 2000. (The FDA has already initiated this process for two device types, which will be completed separately.)
Manufacturers of the 25 remaining device types must submit the requested information within 120 days. The FDA will review the submitted data and, based on the risk level, issue regulations for each device type that either will require manufacturers to submit premarket approval applications or will re-classify the devices into Class I or Class II.
Link to Federal Register notice
More ...
Link to FDA’s Center for Devices and Radiological Health Web site
More ...

Praise the Lord for the hard work of so many people, in particular...Dr. Diana Zuckerman,Ph.D., President of the National Research Center for Women and Children. Her knowledge, experience and determination have resulted in amazing changes at the FDA. She has been working on this for years.

Her testimony in front of the FDA June 12 of 2007 and her persistence in petitioning the GAO to make the determinations they have are very significant in getting this result.

I applaud her constant and consistent advocacy of the health of all Americans.

God Bless Her...Lana Keeton
Founder, Truth in Medicine
truthinmedicine@bellsouth.net 305-342-8002

STATEMENT OF DIANA ZUCKERMAN, PH.D.

President, National Research Center for Women & Families

Before the Subcommittee on Health
House Subcommittee on Energy and Commerce

June 12, 2007

Thank you for the opportunity to testify about the Subcommittee’s discussion draft FDA legislation. I am Dr. Diana Zuckerman, president of the National Research Center for Women & Families, an independent think tank that analyzes and evaluates a wide range of health programs, policies, and agencies, including the FDA.

I am trained as an epidemiologist at Yale Medical School and for more than a dozen years I worked in Congress, the U.S. Department of Health and Human Services, and the White House, determining which health policies were working and which ones were not.

Our center is an active member of the Patient and Consumer Coalition, comprised of nonprofit organizations representing patients, consumers, public health researchers and advocates, and scientists. The Coalition is working to strengthen the FDA and to ensure that FDA approval once again represents the gold standard of safe and effective medical products. Our Center is also an active member of the FDA Alliance, which is a coalition of pharmaceutical companies, medical device companies, former FDA officials, and consumer and patient organizations that work together to support increased resources for the FDA. I am proud to serve on their Board of Directors.

In my testimony, I am speaking on behalf of the National Research Center for Women & Families, not on behalf of other organizations we work with. I will start my testimony by focusing on medical devices and MDUFA, but will also include a brief analysis of PDUFA and other issues that you are considering in your legislation.

Every American relies on medical devices -- whether they use band-aids, contact lenses, or pacemakers. Baby boomers increasingly rely on implanted medical devices, whether hips, heart valves, or wrinkle fillers.

More than 5,000 medical devices were approved by the FDA last year. Almost all (98%) were cleared through a “quick and easy” process that usually does not require clinical trials to prove that these medical devices are safe or effective. As a result, some of these devices are neither safe nor effective.

Are medical devices “proven safe and effective”? Not usually.

The American public is very concerned about the FDA drug approval process, wondering how Vioxx, Avandia, and so many other drugs can be prescribed by physicians who are not given accurate information about the risks, and then sold to millions of patients who are unable to make informed decisions about their own medical care. For all its faults, however, the FDA approval process for prescription drugs is much more rigorous than the device approval process.

There are two ways that the Center for Devices and Radiological Health (CDRH) approves medical devices, and neither has the same criteria – to prove that the product is safe and effective – that the drug approval process requires. In a book published this year, FDA officials state, “The FDA is responsible for ensuring that there is reasonable assurance that a medical device will be useful while not posing unacceptable risks to patients.” That standard is certainly more vague and less stringent than the standard for prescription drugs, and yet medical devices are just as important for saving lives and protecting the quality of people’s lives.

The statement is an accurate reflection of the FDA approval process for medical devices. In fact, most medical devices – approximately 98% -- are allowed to be sold after a review that does not usually require any clinical trials. Device companies don’t need to prove that their products are “safe and effective” – they only need to prove that they are “substantially equivalent” to a product that was on the market before 1976. This much less rigorous process is known as the 510(k) process.

The 510(k) process was intended to be a temporary alternative to a full review when the FDA first was given the authority to regulate medical devices in 1976. This authority was the result of thousands of women being harmed by the Dalkon Shield IUD (intra-uterine device), which was found to cause serious infections, permanent infertility, and even death.

When the FDA started regulating medical devices, there were thousands of different devices on the market that had never been proven safe or effective. Most were “grandfathered” -- allowed to stay on the market -- with the FDA requiring some companies to conduct and submit safety studies for the first time. At the same time, to be fair to companies that wanted to sell medical devices that were similar to untested devices that were already on the market, section 510(k) of the Food, Drug, and Cosmetics Act gave the FDA the authority to “clear a product for market” if it was deemed “substantially equivalent” to medical devices already being sold.

We think that decision made sense. If logic had prevailed, however, FDA would have eliminated or at least drastically reduced their use of the 510(k) process in the three decades since 1976. Instead, the process was continued, with the rationale that device manufacturers are constantly improving their products and that it would stifle innovation to require each small change to be reviewed by the FDA in the more careful premarket approval (PMA) process. The assumption has been that a medical device that has been modified very slightly does not need to be tested as carefully as a new product.

Unfortunately, over time the definition of “substantially equivalent” was changed to include almost any product for the same medical condition. The FDA is now using the 510k process for 98% of the medical devices that they review. As a result, new products, using new materials, or a new mechanism, made by a different manufacturer, are being reviewed as if they were a mere tinkering improvement over previously sold products. In fact, it doesn’t even matter if the previously sold product was subsequently found to be unsafe or ineffective and is no longer for sale. There are medical devices on the market today that were approved as “substantially equivalent” to products that were subsequently recalled for safety reasons.

Why Clinical Trials are Needed

Even small changes to a medical device can affect safety, and can be very dangerous. For example, when Bausch & Lomb added MoistureLoc to their contact lens solution, the new product was approved through the 510(k) process. No clinical trials were required. The result: severe eye infections causing blindness and the need for corneal transplant surgery.

Although the standard of “substantially equivalent” for devices sounds almost like the standard for a generic drug, the reality is completely different. Many medical devices approved by the FDA through the 510(k) process are not like any medical devices already on the market, and are instead made of different materials, used for different purposes, use a different technology, or are otherwise “new and different” rather than slightly improved.


A Few Examples of 510(k) Device Disasters

TMJ Implants: Vitek jaw implants were cleared as substantially equivalent to silicone sheeting, which was made from a different material that was not developed for use in a joint. The Teflon from the Vitek implants broke off into particles that caused bone degeneration in the jaw joint and skull. Some patients can no longer eat, others have holes in their skulls.

Bladder Slings: Boston Scientific won approval for a ProteGen bladder sling to treat stress incontinence. The sling, made of a new synthetic material coated with collagen, caused vaginal erosion.

Pacemakers and Defibrillators: Frequently reviewed with the 510(k) process, tens of thousands of pacemakers and defibrillators have been recalled in recent years. When these products are defective, patients can die.

ReNu with MoistureLoc Contact Lens Solution: Bausch & Lomb’s contact lens solution was found to be an excellent breeding ground for a fungus that caused severe eye infections. One-third of consumers who developed the eye infections needed to have their eyesight restored with corneal transplant surgery. The product was recalled in May 2006.

Complete MoisturePlus Contact Lens Solution: Advanced Medical Optics’ contact lens cleaning and storing solution was found to not protect against a different bacteria that can cause severe eye infections. It was recalled in May 2007.

Shelhigh heart valves and other implants: In April 2007, the FDA seized all implantable medical devices from Shelhigh, Inc., after finding deficiencies in manufacturing. The devices are used in open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. “Critically ill patients and pediatric patients may be at greatest risk,” according to the FDA.





How does this affect the practice of medicine? According to Dr. Donald Ostergard, past president of the American Urogynocologic Society, many medical devices used to treat incontinence and other urological conditions were not required to conduct clinical trials before being sold. As a result, surgeons considering the use of a new device must rely on colleagues’ anecdotal experience or promotional information from the manufacturer. He points out that some have caused serious problems that were not identified until the device had been used on hundreds or even thousands of women. As a result, patients who started out with a minor health problem can end up with many surgeries and with permanent and debilitating health problems.

Part of the problem is the very loose definition of “substantial equivalence.” As long as a product is used for the same general purpose – such as the treatment of depression or cancer – and if its risk to benefit ratio seems to be similar, a product can be approved as “substantially equivalent.” Not to be glib, but this would be like saying that cheese is substantially equivalent to peanuts or bread because all three are food that provide nutrition, and each has risks and benefits for the general population. But, if you are allergic to peanuts, or sensitive to milk products, you know that there is a world of difference regarding how those foods will affect you, and the percentage of people who can be harmed by them. They are not interchangeable.

In addition to other safety concerns about the 510(k) process, current law permits manufacturers to hire a third party to review their devices, instead of the FDA. The goal is to speed up the review process and reduce the FDA workload. However, according to the FDA, the program has not reduced the FDA workload because of the use of FDA staff to administer the program. The benefit to device manufacturers is modest since the companies must pay the third parties and the review time is reduced by an average of less than two weeks.

Why are 98% of Medical Devices Reviewed Through the 510(k) Process?

CDRH has a modest budget and fewer resources than the Center for Drug Evaluation and Research (CDER). And yet, they have a greater workload in terms of number of devices submitted to them for review every year. It is not surprising that the FDA has increasingly relied on the less labor intensive 510(k) process to review the thousands of products submitted for review every year.

Under the current law, 80% of 510(k) reviews are completed within 90 days. This is a very short turnaround time, making it difficult for the more complicated applications to receive careful evaluations.

In speaking with physicians, scientists, and consumer advocates, we have developed several suggested changes in the 510(k) review. The goal is to increase useful information for physicians and improve safeguards for patients. These changes, supported by most members of the Patient and Consumer Coalition, include:

Excluding implanted medical devices from the 510(k) process;

Requiring clinical trials for all medical devices that could harm patients and consumers; and

The FDA needs to establish an appropriate definition of “substantial equivalence.” They should revert to the original intent of the 510(k) process: the review of products that are substantially equivalent in terms of intended treatment, form, what they are made of, mechanism, and function.

We know that device manufacturers believe that the 510(k) process is safe enough and necessary to get products to patients more quickly. From a policy point of view, however, many medical devices cleared for sale by the FDA under the 510(k) process are not reimbursable under Medicare or Medicaid, or by private insurance companies. The Center for Medicare and Medicaid Services (CMS) and insurance companies have higher standards for reimbursement than the FDA has for device approval. Although thousands of medical devices are cleared for market by the FDA through the 510(k) process every year, many Americans will not have access to all those products because insurance companies require published research to prove that the products are safe and effective. For many important products, the patient will not benefit at all until those studies are done.

If medical devices are not reimbursable until peer reviewed studies are published, then the 510(k) process is NOT getting many new, innovative products out to patients more quickly. Research will still need to be conducted. Wouldn’t it be better to make sure that the studies are evaluated by the FDA through the PMA process, to make sure that the analyses are not manipulated to minimize the risks?

We strongly support the Committee’s plan to require a study of the 510(k) process. Either the IOM or GAO could do a credible study and report, and we urge you to determine which can do the best job in the next 12-18 months.

The “Full Review” Premarket Approval Process

The more rigorous approval process, which is similar to the process for prescription drugs, is called the premarket approval (PMA) process. Drug companies and device companies must conduct clinical trials and other tests to determine that their products work well and are safe. However, the drug approval process requires that the products be “proven safe and effective.” The approval process for medical devices has a lower standard: the products must provide merely a “reasonably assurance of safety and effectiveness.”

That rather vague definition is not an appropriate standard. In our Center’s review of thousands of pages of FDA advisory committee transcripts, we found how dangerous this vague definition can be. For example, at an FDA advisory panel meeting on the Kremer LASIK device, a physician explained that she recommended approval “because I did not see from the data that this was totally unsafe or totally ineffective.” At a different FDA advisory panel meeting for a device to treat Alzheimer’s Disease, a neurosurgeon recommended approval after saying, “Only time will tell whether or not this will pan out to be helpful.” The FDA went along with advisory panel recommendations for approval almost every time. With standards like these, patients and their families will waste billions of dollars on products that are not proven safe and effective, do not benefit them, and that replace products that might have helped save their lives or improve the quality of their lives.

There is no logical reason why the standard for the PMA should be any different than the standard for prescription drugs. All medical products should be required to be proven safe and effective. That does not mean that the product has no risks, but it should mean that the benefits outweigh the risks for the people who will be using the product.

Post-market Studies, Surveillance, and Advertising

Since so many medical devices are approved through the 510(k) process, and the rest are approved on the basis of the vague criteria of “reasonably safety and effectiveness” it would make sense for CDRH to devote a great deal of resources to post-market surveillance. In fact, the CDRH often requires post-market studies be conducted, but they do not monitor those studies to make sure that they are done appropriately.

For example, in 2000 CDRH approved saline breast implants on the condition that 10-year post-market studies be conducted. Because of the enormous media attention and controversy, the CDRH required the implant makers to present their 5-year data at a public meeting in 2003. At the meeting, it was shown that one of the companies, Mentor Corporation, had lost track of 95% of their augmentation patients after 5 years.

Any epidemiologist will tell you that when you lose track of 95% of your patients, your study does not provide useful safety information. The FDA criticized the company, and encouraged them to re-contact more of the patients in their study. However, even with more extensive follow-up, more than two-thirds of the patients were missing from the post-market study at the six-year follow-up. And yet, the company continued to sell their product with no penalties. They even came back for approval of their more controversial silicone gel breast implants two years later, and those implants were approved on the basis of the company’s promise to study those women for 10 years. In other words, they made the same promise that they had previously broken, and the FDA approved their product anyway.

In a recent book, the director of CDRH wrote that “the premarket evaluation program alone cannot assure continued safety and effectiveness of marketed devices” and explained the need for post-market surveillance to determine the risks after a product is approved and widely used. Thus far, those efforts have been under-funded and ineffective. Registries for implanted medical devices and improvements to the adverse reporting systems would provide important information to doctors and patients about devices already on the market. The Energy & Commerce Discussion Draft of MDUFA authorizes additional funding that would make post-market surveillance possible, but does not require specific post-market surveillance activities.

Under current law, if an implanted device is recalled, it is unlikely that the men, women, or children who have that device in their bodies will be notified. Doctors and medical centers will be notified, but they may not be able to notify all – or even most – of their patients. Registries for implanted devices, using unique identifying numbers, are needed to help ensure that patients will be notified as quickly as possible if there is a defective implant inside their body.

MDUFA does not include any user fees for the review of direct-to-consumer (DTC) advertising, which has been increasing greatly for medical devices. For example, in the spring of 2007, Allergan Corporation has extensive DTC ad campaigns for three medical devices: gastric lap bands (which are surgically inserted for weight loss), Botox, and Juvederm; the latter two devices reduce wrinkles, and are injected by a physician. Allergan is currently preparing an ad campaign for silicone gel breast implants. The ads on their Web site and on TV feature enthusiastic patient testimonials with no meaningful risk information. According to the Allergan Web site, the patients receive free treatment, worth thousands of dollars, as compensation for their testimonials.

Speed and Safety

The MDUFA Discussion Draft would not speed up the 510(k) process, which is already very fast, reviewing 80% of the products within 90 days. That is a wise decision. It is important that the legislation focuses on decreasing the cost of user fees for the smaller companies, but does not reduce the already very inexpensive user fees for 510(k) reviews.

The decrease in funding for the PMA process seems reasonable, as long as the process is not required to speed up. The total funding, and the increase in appropriations authorized, would help ease the stress on CDRH staffing levels and improve their ability to conduct careful reviews.

Third Party Inspections

Rather than FDA conducting inspections of manufacturing facilities, device companies can directly pay a third party to do the inspection, and can negotiate the price of the inspection. The current law includes very modest restrictions on third party inspections of Class II and Class III medical devices, which are the most stringently regulated devices. The current law allows two consecutive third-party inspections, after which the FDA must conduct the next inspection (unless the FDA issues a waiver).

The MDUFA discussion draft wisely does not expand this program. Critics have compared third party inspections to allowing parents to select and pay a third party to determine school grades for students, or allowing employees to hire a third party to make salary and promotion decisions. According to 2007 FDA testimony, the agency has spent millions of dollars on this program, but it has very rarely been used. We urge the Committee to ask the GAO or IOM to evaluate whether this program is workable and cost-effective, or whether the funds should instead be used to hire more FDA inspectors.

Progress on PDUFA and Safety Issues for Drugs, Devices, and Biologics

The FDA discussion draft legislation includes many important provisions that will greatly improve the safety of drugs and potentially the safety of all medical products.

We strongly support the proposed addition of $225 million over five years in new safety money, and urge Congress to make sure that funding is used to improve resources to conduct post-market surveillance and modernize the FDA’s computer systems, including software for reporting and analyzing adverse reactions for drugs and devices. We also strongly support the provision that would include patient and consumer organization representatives in the negotiations for any PDUFA renewal and MDUFA renewal. The patient and consumer organizations represented should be full partners at the negotiations, and should not have financial ties to pharmaceutical or medical device companies.

The proposed legislation builds on the best REMS provisions in the Waxman-Markey bill (HR 1561), giving the FDA the authority it needs.

For drugs and medical devices, it is important that there be required registration of all Phase II thru IV trials. We agree with the discussion draft provision that the results of all these studies should be made publicly available, and that should apply to studies on medical devices as well as drugs.

In Section 5, the discussion draft includes the Senate bill’s section 201, which is based on a suggestion by former FDA Commissioner Dr. Mark McClellan and introduced in a bill by Senators Gregg, Burr, and Coburn (S. 1024). In combination with REMS, these databases from Medicare and elsewhere are very important because they can be used to detect short- and long-term safety problems in drugs and devices.

We support the discussion bill’s recognition that nothing in these FDA bills pre-empts state tort laws.

Additional Suggestions for Devices and Drugs

As a member of the Patient and Consumer Coalition, our Center strongly supports several recommendations to strengthen provisions in your discussion draft of PDUFA and other FDA legislation.

Although the conflicts of interest” provision is a clear improvement over the Senate bill, we believe that conflicts of interest should be eliminated in FDA advisory committees for drugs and devices, by excluding any members with stock, stock options, or other financial ties to companies that have stakes in the topic under discussion. The discussion draft includes a good provision on conflicts of interest, but it is essential that “conflicts of interest” be defined in the law as a financial relationship within the last 36 months. Otherwise, FDA advisory committees could include members who received million dollar honoraria from the company whose product is under review just 13 months prior to the committee meeting. And, since stock and stock options are so strongly affected by FDA decisions, either should always be unacceptable for advisory committee members.

Better consumer protections regarding DTC advertising is needed. The discussion draft section on DTC advertising is a good start, but needs to be strengthened by making pre-clearance of all DTC advertising for drugs and devices mandatory rather than voluntary. An effective system of civil monetary penalties is also needed, and those must be substantial to be an effective deterrent.

Strong whistle-blower protection provisions are needed, as well as a provision clarifying the right of FDA officers and employees to publish scientific articles, with proper disclaimers. The right to publish could have meant earlier warnings about the risks of Vioxx, Avandia, Actos, and other blockbuster drugs and devices, saving the lives and improving the quality of life of many Americans.

In addition to the provisions in the discussion drafts on making data available, we strongly urge that you consider the Senate provisions making FDA reviews, evaluations, and approval documents promptly available to the public, including dissents and disagreements. In addition, the FDA should be required to publish observational study results, in addition to clinical trial results.

We support legislation by Representatives Tierney, Emerson, and Stupak that would create a separate Center for Post-market Evaluation and Research with real clout within the agency, but strongly urge that the Center include devices as well as drugs and biologics.

In conclusion, thank you for the opportunity to testify and share our views about the discussion drafts. You have made important progress, and we appreciate your consideration of provisions that would strengthen this legislation to help ensure that safe and effective medical products are available to all Americans.

The FDA, insurance companies, pharmaceutical companies, medical device companies,and congress have much to answer for as to how medical treatment is determined. In the end, it is really up to the physician to educate him or herself in order to provide the best service to patients. Just as it is in my profession, continuing education is an ethical responsibility.

I just wanted to let people know that may not be aware, the second article is out. Below is the link.

More ...

I'd like to thank every person who has come forward, men and women, to tell the horrors they have faced after surgeries involving mesh. It doesn't matter the maker or distributor, in the end all of it has caused havoc within the body.

If it wasn't for Lana, Suzanne and many others like them I don't know where I'd be or IF I'd be. The pain and torment immediately after surgery, the doctor refusing to acknowledge that there was anything wrong, the infections and more pain all contributed to many weeks of dark thoughts. It was only through these wonderful people online that I found I wasn't crazy, that I was a victim.

My TVT-O eroded, not weeks, months or years after insertion but within days. It was in plain sight and still my doctor refused to believe I had any issues related to the mesh. Only by seeing a colleague of my doctor while she was out of town did something get done. Surgery for partial removal was held the very next day. What remains, like all others I was told, would take a very painful and delicate operation to remove and no guarantee of less pain could be given. As a matter of fact I would probably find myself in worse shape.

So, here I am. With every bend of my body I feel it slicing. My "saddle" goes numb which makes sitting or walking painful. I use a cane when I have to walk any distance as the top of my left thigh first burns then goes numb, leaving me one leg to stand on. I have to take a pillow everywhere I go. Underwear hurts. Jeans are a no-no. Both inner thighs burn 24-7. Life is miserable.

I was told it was all in my head. Then I was told it was caused by my back. Then it was because I'm older or I smoke. I'd like to tell them check NONE OF THE ABOVE and start looking in the pelvic region where they deposited that little strip of polypropelene MESH.

Please stop the madness! No more mesh! No more people like me; out of work, in constant pain, out of hope.

The old saying, "Not tonight honey, I have a headache."
The new saying, "Not tonight honey, my mesh is eroding."

Hello,
Like all the others, I was "Sold a bill of goods". Myself and others injured are treated like "BY-CATCH" in the fishing industry. We are the "Collateral damage" or the "Failed percentage". Other than numbers, it seems we have no voice. Our monies have been spent on surgeries, doctor fees, prescriptions, mileage to and from major medical centers. We have no spare change to spend fighting our cause. Who will be OUR sponsor?

WHO IS OUR SPONSOR WITH THE DEEP POCKETS? Unlike the big mesh manufacturers, we patients have no recourse, no sponsors,no case big enough for med-mal attorneys, only bills to pay. Many have lost jobs, marriages,and are deep in debt. Some have even died.(See FDA)

Our lives have been changed by the mesh and the lies that persist... not for the good, mind you.
Prolonged anesthesia (4 hrs) can cause brain damage, and multiple surgeries can result in failure. The cost of all this is staggering.

In the age where men go to the moon, flat chested women get breasts, and the childless get 14 children, where is the justice? All I ever wanted was to be DRY; now thousands of dollars, lost time, and suffering, I am finally "normal" though will never be as before.

THIS PROBLEM NEEDS TO BE ADDRESSED!

suzanne, i am so sorry you are having to deal with the. my thoughts and prayers are with you. thank you for coming forward and making everyone aware of the potential complications. keep up the fight!!

Please visit www. truthinmedicine. us. com

Please register the complications you suffer from the implantation of Synthetic Surgical Mesh on the International Registry of Complications.

It meets all the requirements of the U.S. Food and Drug Administration in order to have Synthetic Surgical Mesh removed from the market here in the United States.

Truth in Medicine offers solutions to stop future harm from the implantation of Synthetic Surgical Mesh. We are in direct contact with members of Congress.

Our voice has been heard at the FDA. On October 21, 2008, the Public Health Notification at the end of this posting was issued primarily because of the relentless efforts of Jim Shull, a Director of Truth in Medicine.

MUCH MORE HAS TO BE DONE…

HELP TRUTH IN MEDICINE TO STOP THE IMPLANTATION OF SYNTHETIC SURGICAL MESH IN HUMAN BEINGS….

GO TO > > www. truthinmedicine. us. com.

PLEASE REGISTER YOUR COMPLICATIONS TODAY. YOU CAN NOT CHANGE WHAT HAS HAPPENED TO YOU.

YOU CAN STOP IT FROM HAPPENING TO OTHERS!!!

GOD BLESS, LANA KEETON
FOUNDER, TRUTH IN MEDICINE
truthinmedicine@bellsouth.net
305-342-8002


---------------------------------------------
FDA Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence
---------------------------------------------

FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.

FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.

The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.

In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels .

Background
A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum.

Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity.

Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.

Talking to your doctor
Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene.

Questions you should ask the surgeon before you agree to surgery in which mesh will be used:
• What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
• If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
• What’s been your experience in dealing with the complications that might occur?
• What can I expect to feel after surgery and for how long?
• Are there any specific side effects I should let you know about after the surgery?
• What if the mesh doesn’t correct my problem?
• If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
• If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Reporting complications to the FDA
In order to help FDA learn more about possible problems with surgical mesh, it is important that both physicians and patients report complications that may be associated with this product.
You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.

• Online : More ...

• Mail : use postage-paid FDA form 3500 available at: More ...
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

• FAX: 1-800-FDA-0178

Related Links
• FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

• Information on Surgical Mesh for Hernia Repairs

Updated October 21, 2008

Suzanne is a friend of mine. I know how much she's suffered from her surgery. I too have SUI and thought about having this surgery. Because of all the suffering Suzanne has indured, I decided NOT to have it done. I too saw the same Dr. she saw: he scared the H_ _ _ out af me the first time I saw him. I'm devestated that Suzanne has had to suffer because of his ignorance; but for her sharing her story, I would have had the same surgery. Thanks Suzanne for sparing me the same pain and suffering.I hope you get your hearing you deserve it. Love you and wish you the best.

I admire Suzanne for putting her story out there, particularly because, frankly it's personal and I am SURE that there are many more out there just like her that are to timid to tell their horror stories of surgical mesh.

It saddens me to hear the pain and discomfort, and emotional trauma that Suzanne has had to go through due to the implantation of this surgical mesh. And makes me question how on earth did this ever make it through an FDA approval if this is what it is doing to the people it is implanted in and why wasn't she informed of the risks of implantation....? Surely it would have been under testing and FDA scrutiny for long enough for others to report similar problems!

I will sure think two and even three times if not more before I undergo even a simple produre reccommended by a doctor and approved by the FDA!

Thanks for sharing your story!

Maureen,

Thank you so much for your comment. If you will also read article two, it clarify's the fact that no testing has to be done on these Class II Devices in order to gain FDA approval.

For Class II Devices, the manufacturer ONLY has to show a substantial equivalence to a device already on the market to receive FDA approval.

We are the clinical trials, and we are all being used as guinea pigs!

This DOES NOT only pertain to mesh products, but EVERY Class II Device approved by the FDA. One really needs to research before allowing anything to be implanted.

At the time I had it done, I tried to research, but I simply didn't know how to do this, now I do!

Before this happened to me, I had never even heard of the FDA MAUDE Database.

I have not had this surgery but Suzanne is my close friend and thanks to her I will not have this procedure and will not have to deal with this
problem.

My greatest concern is why does the FDA keep this mesh or ANY mesh on the market. I also am concerned with the fact that they know this mesh is not safe - how many other devices have been produced and have been patened and allowed to be
on the market as fast fixes without regard or study as to the negative sides for the recipient.

America is or was a christian country. Now the problem is everyone wants a fast high dollar to make their BMW payments.

I know Suzanne will not let this pass by without
really letting everyone know how it has affected her life. We need more people like her.

Love You Suzanne
Your Best Friend.

I had a hernia repair by the same physician that Suzanne used. I was also told this would fix the problem. I have nothing but problems with an itch and a sore spot that really hurts when I move or bend over wrong.

I think Suzanne has done a great job with her research and her willing to help others.

Too many of us trust in our doctors to make decisions that are safe and healthy. We should be able to do that knowing that our doctors have the FDA to protect and confirm their decision to use a product. Suzanne has clearly made me realize we are in charge of our own health and need to research everything. Thanks Suzanne for your ongoing efforts to make sure that people are aware so they can research and make an educated decision for their health.

Hi Suzanne,
I so admire your strength & tenacity in exposing the Ethicon TVT Mesh for all it's flaws & potential life threatening capabilities.
Many people were brought up to believe that physicians are unquestionable. Your story shows that there can never be enough questions asked. But more importantly, we must be our own researchers.
I know your journey is far from over....with 'patience' a prominent word in your life. Here's hoping you are personally heard in the congressional hearings and the FDA is, finally, held accountable.
You Go Girl!

I also had a "mesh" device implanted in Noveember, 2007. I leaked worse than I ever did before the surgery. I waited another year and in October, 2008, my doctor was to go in an tighten the sling. However, he told me after surgery that I had tons of scar tissue built up and the surgery was more intensive than he had expected. He used cadaver tissue for this surgery. After this surgery I could not go to the bathroom and after several procedures to "clip" the some stitches (which did not work) and then another one to put a catheter into my stomach (because it was close to Christmas and my problems would interfer with his holidays. I then had to have the stomach catheter replaced before he finally went back in during January to cut the sling in half. I have had 4 surgeries since October 30, 2008 and now I am leaking worse than I ever did. I feel like my doctor is hiding some info from me and plan to keep a close eye on this information.

Peggy,

I left you a message on your post to Suffering in Silence from a Medical Device - Surgical Mesh (Part 2)

I will be more than happy to assist you any way I can.

You need to check the statute of limitations for filing a claim, as you may very well be able to hold the manufacturer, and/or your doctor accountable, if for nothing more than all the expenses from your multiple surgeries you have endured.

There is a statue of limitations in every state.

Best ~ Suzanne

The piece of mesh that was wrongly inserted in my daughter has ruined her quality of life. She can't stand, sit or walk for more than a few minutes at a time. She was a truck driver and had to leave her job because it was impossible to drive while in excruciating pain.

I hurt for her 24/7...If I could absorb some of her pain, would gladly do so.