The Injury Board Commentary - Medical Devices & Implants - Most Commented

FDA Meeting Held to Address Complaints About the Medical Device Approval Process

Carrie Strasser — Mon, 27 Apr 2009 14:44:55 GMT

The New York Times reported last week that a rare internal meeting was held by the FDA on Wednesday to address the complaints surrounding the medical device approval process.

Dr. Donna-Bea Tillman, director of the agency’s office of device evaluation, sent an e-mail message on April 10 announcing an “all-hands meeting” to discuss the strategic direction of the device center. Such a broad-based meeting that includes all scientists within the device evaluation office has not been held for years, two agency officials said.

This meeting was spurred by letters to President Obama signed by nine scientists alleging that agency officials had acted improperly and put patients at risk by approving medical devices for use in spite of numerous objections from scientists reviewing the devices.

These letters have led to the opening of a Congressional investigation and a critical report of the device center released by the Government Accountability Office in January. Additionally, Congress is to propose legislation this week asking the Institute of Medicine to investigate the device division.

Specific devices that the scientists complained about were imaging equipment used to detect breast cancer and an orthopedic knee device. The scientists also charged that the agency has allowed hospitals to clean and reuse certain devices intended for only one use.

This meeting will hopefully be the first step toward greater concern for patient safety when it comes to medical devices. As of now, many patients harmed by certain medical devices have no recourse through the judicial system. However, if the approval process becomes more rigid, this could prevent avoidable injuries due to faulty medical devices. For more information on medical devices, click here.

Originally posted at InjuryBoard by Carrie Strasser

A Possible Breakthrough for the Treatment of AIDS

David Mittleman — Thu, 13 Nov 2008 12:17:40 GMT

It has been over 27 years since the acquired immunodeficiency syndrome, or AIDS, was first reported in the United States in the early 1980's. The syndrome is a set of infections and symptoms that grow out of the human immunodeficiency virus or HIV. HIV is transmitted through direct contact with mucous membrane or the bloodstream with a bodily fluid that is infected with HIV. Transmission of HIV can involve any form of sexual intercourse, blood transfusions, sharing contaminated hypodermic needles, exchange between mother and baby during pregnancy, childbirth, or breast feeding.

AIDS in a world-wide pandemic, with an estimated 33.2 million people having lived with the disease, and kills an estimated 2 million people from all social and economic groups each year. HIV and AIDS have been treated with the use of antiretroviral medication, which reduces the mortality and morbidity of the HIV infection. However, this treatment is expensive and not available in many countries.

An American man living in Berlin, who had been infected with the AIDS virus for more than 10 years, underwent a genetically selected bone marrow transplant. The result appears to be nothing short of a medical miracle. Twenty months after undergoing the procedure, he no longer tests positive for AIDS. Doctors at Charite Hospital and Medical School in Berlin say that tests on his bone marrow, blood and tissues have all been clean.

The patient’s doctors caution that this may be just a fluke. There is no doubt that this case is the brightest hope that we have seen in the history of this worldwide plague. This is not the first time that bone marrow transplants have been used in an attempt to treat HIV/AIDS. There had been 32 previous attempts between 1982 and 1996, of which two cases showed an eradication of HIV.

The procedure was developed by Dr. Gero Huetter, who is a hematologist. He set out to treat the patient’s leukemia with a bone marrow transplant, and remembered that he had read an article that discussed a genetic mutation in some people that seemed to make them resistant to HIV infection. The mutation, called Delta 32, prevents HIV from attaching itself to cells by blocking a gateway receptor called CCR5. The mutation must be inherited from both parents, with only one out of every thousand Europeans and Americans. Dr. Huetter was able to find a donor that matched the patients bone marrow type from a pool of 80 suitable donors.

The patient had to endure powerful radiation and drug therapy to kill the infected bone marrow cells and disable his immune system. This treatment is fatal to recipients 20-30% of the time. Due to the risks and expense of the treatment, it is not ready to be an initial treatment method. But this could be the first step in leading to the development of gene therapy through stem-cell research, which is necessary to block the expression of CCR5, therefore inhibiting the ability of HIV from replicating. Some day this treatment could be the new standard of care for AIDS treatment, and failure to offer this course of therapy could subject doctors to liability for medical malpractice.

Although this new development gives reason for optimism, prevention is still the first line of defense against HIV. It is important to practice safe sex or abstinence, use sterilized hypodermic needles, and get tested for HIV/AIDS.

Originally posted at InjuryBoard by David Mittleman

Millions of Diabetes Glucose Test Strips Recalled

Paul Napoli — Sun, 26 Dec 2010 21:34:10 GMT

December 26, 2010

Abbott Diabetes Care, a division of Abbott Laboratories, is voluntarily recalling 359 million test strips used by diabetics to monitor blood glucose levels.

According to the U.S Food and Drug Administration (FDA) release, these recalled test strips may give falsely low blood glucose results. The low readings may cause the user to take action to raise the blood glucose or fail to treat high blood glucose levels.

The following brands of test strips are affected:

Precision Xtra Blood Glucose Test Strips

Precision Xceed Pro Blood Glucose Test Strips

Precision Point of Care Blood Glucose Test Strips

Medisense Optium Blood Glucose Test Strips

Relion Ultima Blood Glucose Test Strips

Optium Blood Glucose Test Strips

OptiumEZ Blood Glucose Test Strips

Consumers should check their products to the complete list of products and lot numbers.

“Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health,” said Alberto Gutierrez, Ph.D., director for the Office of In-Vitro Diagnostics in FDA’s Center for Devices and Radiological Health. “FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future.”

Consumers with these test strips should stop using them and switch to an alternate testing method or purchase unaffected test strips if available. Those people who have neither should not stop testing their blood glucose, but continue to do so with these precautions:

Precaution 1: Check the amount of time it takes for your blood glucose meter to start the “countdown” after you first apply blood to the test strip. Start timing immediately after blood first makes contact with the test strip. If your meter takes longer than five (5) seconds to start the countdown that test strip is defective and the result should not be used.

Check the time for each test strip you use because all of the strips in a package may not be affected to the same degree.

Precaution 2: If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider.

Pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).

Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.
Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may have no symptoms at all before they develop unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or a seizure. If you are unable to obtain unaffected strips, you should contact your health care provider for advice on how to treat these symptoms before they occur.

Healthcare facilities should also stop using these test strips and switch to unaffected lots or another testing method. If these alternatives are not available in the facility, the FDA says they should:

Verify any critical glucose test results (e.g., test results that may be used to adjust insulin therapy in vulnerable patient populations) generated on the Precision Xceed Pro Blood Glucose Test System using a central laboratory blood glucose method. Medical judgment should be applied when deciding whether to act on results prior to verification.
Verify any Precision Xceed Pro Blood Glucose Test System results that do not match a patient’s symptoms, or seem unexpected for the patient’s clinical status, using a central laboratory blood glucose method.
When using the Precision Xceed Pro Blood Glucose Test System, take precautions to reduce the chance of an erroneous reading. Limited evidence suggests that results may be accurate using strips from affected lots if fill time does not exceed five seconds. Monitor the amount of time it takes for the Precision Xceed Blood Glucose Meter to start the “countdown” after blood is first applied to the test strip. If the amount of time exceeds five (5) seconds, discard that test strip immediately because the blood glucose result may be erroneously low. In addition, if this occurs:
i. Note the specific lot number of that test strip;
ii. Notify Abbott Diabetes Care to report the observed problem with that lot by calling 1-877-529-7185;
iii. Make sure to check fill time on each individual strip during use and do not assume if one strip in a package/lot appears to be unaffected, that all strips in that package/lot are unaffected.

Abbot will replace the recalled product free of charge. However, it may take up to two weeks for delivery.

Consumers can visit the Abbott Diabetes Care recall website or call customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Español) for more information and instructions for returning the recalled test strips.

Originally posted at InjuryBoard by Paul Napoli

Metal Hip Implants Cause Chemical Chain Reaction

Joe Saunders — Sat, 01 Oct 2011 10:10:25 GMT

It has been widely reported that metal on metal hip implants such as the DePuy ASR are failing at an alarmingly high rate. An article in today's New York Times newspaper provides a scientific explaination for how the metal debris from these hips interacts with the body to cause these failures.

The process of injury to the tissue of the hip compartment starts when metal debris from the friction of the metal ball on the femur moves on the metal liner in the acetabular cup in the hip. These metal fragments are released into the body and then scavenger cells arrive to attack these foreign substances. The scavenger cells ingest and partially digest the metal fragments. During this process the metal fragments are broken down into ions which are positively electrically charged. These charged ions then react with human tissue. Positively charged ions are known to cause chemical changes in human tissue which can damage the tissue and cause necrosis of death of the human cells. It can also trigger an immune response called metallosis which can cause a loosening of the acetabular cup.

Positively charged ions are known to be travel to different locations in the body through a process caledl electrolysis or electro-osmosis. In short, if there are parts of the body where the ph levels have a gradient change in electrical charge this can cause the charged ions to travel. This scientific theory has not been the subject of any studies that I have seen involving hips and was not discussed in the New York Times article but it could provide an explaination for some of the extensive damage that continues to be found in metal on metal hip implant patients.

It has been known for over a decade that metal on metal hip implants can release metallic ions into the hip compartment but it appears that the hip implant manufacturers ignored this risk in a rush to compete with each other to gain market share and increase profits.

Our law firm is seeing cases involving all of the manufacturers including DePuy, Biomet, Wright, and Smith and Nephew. The DePuy ASR litigation is the most advanced with the DePuy Pinnacle litigation following close behind. Few Bioment cases have been filed but we expect those to increase and we are seeing significant numbers of Biomet hip failures. Smith and Nephew makes the Birmingham Hip Replacement known as the BHR. These have the best success rate so far but there are still failures of the BHR that are clearly caused by the metal ion debris exposure.

The U.S. Food and Drug Administration (FDA) is conducting a study across all manufacturers whoich should shed more light on the differences among manufacturers but it appears that they all suffer from this unacceptable risk of failure posed by the metal on metal articulation. Many surgeons that I have spoken with will not use and metal on metal hip implant because they believe the risk of failure from the metallosis does not justify the purported benefit of longer implant life.

Originally posted at InjuryBoard by Joe Saunders

Vaginal Mesh Implants get Updated Warning from the FDA

Jacob Plattenberger — Tue, 19 Jul 2011 11:48:35 GMT

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue (specifically in pelvic organ prolapse (POP) or stress urinary incontinence (SUI)). It is made from either porous synthetic material or biologic material.

In 2008, the FDA issued a Public Health Notification stating that the issues with the use of synthetic vaginal mesh was a growing concern. However, on July 13^th, the FDA updated the previous Notice with an Alert stating that serious complications associated with surgical mesh for transvaginal POP repair are not rare. In fact there are now reports of thousands of complications from the mesh, with at least 10 deaths being reported.

The mesh product is implanted during surgery to repair POP and SUI. The synthetic mesh has edges that are in some cases piercing the surrounding tissue and puncturing the bladder, uterus, or bowel. The “patches” can also migrate doing irreparable damage as they move around. Women are also suffering horrible infections because of the mesh.

These types of mesh underwent virtually no safety review by the FDA or any other regulatory agency before being put on the market by manufacturers. Once the mesh is implanted it is very difficult to remove. Even after multiple surgeries doctors are sometimes unable to remove all of the mesh which by that point has become infused to the surrounding tissue.

The injuries that women are suffering from this mesh implant are severe and debilitating and could have been avoided had people had the proper information. There are other safer alternatives to synthetic mesh (biological mesh for example) that should be considered before the decision is made to use synthetic materials.

Sometimes these injuries can take years to develop after the initial surgery. In 2010 there were at least 100,000 of these mesh implants performed

Originally posted at InjuryBoard by Jacob Plattenberger

When Greed Motivates Surgery, We All Lose Big

David Mittleman — Sun, 16 Jan 2011 11:16:50 GMT

Usually, when I hear someone has had spinal fusion surgery, I think of it as a last resort surgeons use before permanently altering their patient's body. I know first-hand that people will do just about anything to avoid going through that kind of surgery, including countless hours of physical therapy and simply living with levels of pain they never thought they could tolerate.

Unfortunately, it appears as though some corporations and physicians have profited on pushing for expensive fusion surgery despite high risks and costs. Unnecessary spinal surgeries cost at least $150 billion a year, according to John Birkmeyer, director of the Center for Healthcare Outcomes & Policy at the University of Michigan. Lots of this is coming at taxpayer expense through Medicare claims.

Let's also notice who is offering some of the heaviest criticisms. I wouldn't pay much attention if a tennis player criticized a concert pianist, but when it's an insider of the spinal surgery community, my ears perk up.

“It’s amazing how much evidence there is that fusions don’t work, yet surgeons do them anyway,” said Sohail Mirza, a spine surgeon who chairs the Department of Orthopaedics at Dartmouth Medical School in Hanover, New Hampshire. “The only one who isn’t benefitting from the equation is the patient.”

Wow. So who is benefitting from this surgeries, if it's not the patients, the people who need the care, the people who trusted their lives to the professionals? Let's see:

Surgeons: for starters, spinal surgeons have benefitted from the fact that fusion surgeries doubled from 2002 and 2008, even in the face of evidence that physical therapy may be just as effective with much less risk in treating degenerative disc disease. The average spinal surgeon makes $806,000 a year, more than three times as much as the average pediatrician.

Medical Product Manufacturers: Medtronic, Inc., has made over $840 million last year on their Infuse product alone. Infuse was approved by the FDA in 2002, coinciding with the start of the surgery boom, as a product used to grow bone. Medtronic also just happens to pay heavy royalties to surgeons and spinal surgery firms, although they naturally claim that product usage has nothing to do with such royalties.

And just what benefit does it provide to patients? Interviews with 11 patients from Twin Cities Spine center patients found that the surgery did nothing to relieve their back pain. Nothing.

And what are the costs involved? Only potential addiction to morphine or other painkillers. One patient of the 11 noted above wound up dying from a methadone overdose when he pain became unbearable after the surgery and he couldn't afford his regular painkillers.

Many of these surgeries are being performed on patients who have what is commonly referred to as degenerative disc disease. This means that the source of the pain is just a result in the breakdown of the soft disc in between our vertebrae.

As professionals, we all have ethical obligations to act in the best interests of our clients. I tell my young associates to treat all their clients as if they are a loved one. It pains me to see when other professionals and corporate entities don't take that same approach.

Originally posted at InjuryBoard by David Mittleman

Did You Know... Another DePuy Artificial Hip May Have Safety Problems?

Brett Emison — Mon, 10 Jan 2011 11:08:00 GMT

There has been much written about the DePuy artificial hip recall concerning the DePuy ASR XL Acetabular and DePuy ASR Hip Resurfacing Systems. Safety advocates and others also anticipate a possible recall of the DePuy Pinnacle Acetabulum artificial hips as well. The DePuy Pinnacle replacement hip uses a metal-on-metal design similar that found in the recalled ASR Hip replacement systems. Growing numbers of complaints have prompted concerns with the Pinnacle System.

A number of complaints can be found in the comments to this post at Arthritis Today. There were at least 50 references to DePuy Pinnacle replacement hips.

The Pinnacle System has not been recalled yet, but patients who are experiencing pain and other issues related to the DePuy Pinnacle implant should discuss with their doctor and an attorney immediately.

According to DePuy, the Pinnacle Hip Solution was designed “to help provide a more fluid range of natural motion.” One study that the company’s web site cites from 2002 observed that an estimated 99.9 percent of Pinnacle Hip components remain in use, so a potential recall of this device would affect a significant number of people.

[More on the DePuy Hip Recall]

[More on Johnson & Johnson]

Originally posted at InjuryBoard by Brett Emison

Senate Hearing Highlights Device Victim's Nightmare

Cecelia Prewett — Wed, 05 Aug 2009 14:57:20 GMT

Two years ago, Michael Mulvihill of Bettendorf, Iowa, was driving with his wife to visit his son, daughter-in-law, and grandchildren when he saw a blue light flash before his eyes. He felt his body shaking but thought he’d simply hit some road debris. But he soon realized his heart defibrillator was firing, sending electrical shocks through his body while he was driving on the interstate.

After managing to pull over, Michael was taken to the hospital. A representative from Medtronic, the maker of his defibrillator, confirmed the device had malfunctioned, giving him 22 shocks in just 53 minutes. The wire that connects the defibrillator to the heart was recalled four months later after over a hundred reports of the lead malfunctioning had been reported to the Food and Drug Administration (FDA).

Michael had been diagnosed with an irregular heartbeat, and was implanted with his defibrillator in 2006 to control his heart rhythm and pulse. But the device intended to save his life nearly killed him and the anxiety from the episode led him to take early retirement because his job required so much interstate travel.

Unfortunately, his nightmare continues. Michael cannot hold the manufacturer of his device accountable for their faulty product because a U.S. Supreme Court decision last year gave the company complete immunity.

Yesterday, Michael testified before the U.S. Senate Health, Education, Labor, and Pensions Committee, and asked Congress to pass the Medical Device Safety Act (MDSA), which would restore the right of patients to hold manufacturers of medical devices accountable in court when their devices malfunction.

Michael also joined victims of faulty medical devices from eight states at a press conference where they shared their stories and the importance of this legislation. Mike and Joseph Collins of Georgetown, Texas were both implanted with a faulty device. Michele Meyer and Mark and Janis Baird of Minn., had children who died as a result of their devices malfunctioning. And Avery deGroh, of McHenry, Il., was only 3 when she received nine painful shocks from her faulty defibrillator.

MDSA was introduced in congress by Sen. Edward Kennedy (D-MA), Rep. Frank Pallone (D-NJ) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA), and currently has 101 co-sponsors in the House and 23 co-sponsors in the Senate. This important legislation is critical in ensuring the safety of those patients who rely on these devices.

Both the Senate HELP Committee, and the House Energy and Commerce Health Subcommittee have held hearings on the legislation. The next step is for the Committees and Congress to move the legislation forward, so people like Mulvihill, Mike and Joseph Collins, and Avery deGroh can seek justice.

Originally posted at InjuryBoard by Cecelia Prewett

BioMet Metal on Metal (MoM) Hip Device Allegations

Michael Monheit — Mon, 12 Dec 2011 12:25:54 GMT

Metal-on-metal hip implant devices are a specific type of medical implant used in hip replacement surgery. The hip is the joint in the body that bears the most weight and it is what as known as a “ball-and-socket” joint. The “socket” is a curved part of the large pelvis bone and the “ball” is the upper end of the femur or thighbone. When this joint stops functioning properly, a physician may recommend hip replacement, which involves implanting an artificial hip to replace the natural joint—that is where metal-on-metal hip implant devices come into play. In these devices, metal components replace both the “ball” and the “socket” part of the joint and, in the ideal scenario, enable a patient to live a full, active life.

These metal-on-metal devices can be an attractive alternative to traditional components made of ceramic or even plastic. Metal offers more durability and stability. And lots of medical device companies have jumped on board to start marketing them: Smith & Nephew with its Birmingham Hip Resurfacing System; Wright Medical Technology with the CONSERVE Plus Total Resurfacing Hip System; Corin with the Cormet Hip Resurfacing System; and others such as Biomet, DePuy, Stryker and Zimmer.

But metal-on-metal devices are not turning out to be the medical miracle they have been marketed as. Instead, DePuy has had to recall tens of thousands of its devices, Wright is in the middle of a flood of lawsuits, and the safety of metal-on-metal devices is in serious question.

The main risk that these devices pose is because both components of the hip replacement device are metal. They constantly rub against each other and the friction means that small particles of metal are released into the surrounding tissue. This, in turn, can give rise to a condition known as Cobalt poisoning or Cobaltism, which if left untreated can cause serious health consequences: blindness, cardiomyopathy, cognitive problems, convulsions, deafness, dementia, optic nerve atrophy, peripheral neuropathy, tinnitus, and vertigo. While medical research is still seeking for a causal connection between metal-on-metal hip replacement systems and these disorders, there is a strong enough correlation for the FDA to be concerned enough to launch a series of safety studies.

Originally posted at InjuryBoard by Michael Monheit

Medical Devices - Time For More Oversight, Not Less

Nicole Greer — Thu, 27 Oct 2011 12:14:50 GMT

Do you use a medical device? You probably do, even if you don’t know it. If you have been harmed by a medical device, you may have a legal claim.

Do you wear contact lenses? CooperVision AVAIRA Toric Soft Contact Lenses were just subject to a Class I recall, which is the most serious type of recall, meaning there is a reasonable probability that use of the product will cause serious adverse health consequences or death. The contact lenses were recalled because of a silicone oil residue on the lenses which can cause blurry vision, discomfort, or serious injury requiring medical treatment and jeopardizing vision.

Have you had orthopedic surgery? There is an ongoing safety review of arthroscopic shavers that are used in some orthopedic surgeries, because pieces of tissue, not evident to the naked eye, are remaining in the shavers even after cleaning which can compromise the entire sterilization process.

Those are just a couple of examples of medical devices that have been subject to a recent recall or safety communication.

Medical devices include virtually everything you might come in contact with in a healthcare setting other than drugs. Medical devices include instruments, machines, implants, and other similar items that are not drugs, which are used for the diagnosis or treatment of a disease or medical condition. Medical devices can include things as complicated as an artificial heart or as simple as tongue depressors, as well as a wide variety of devices in between, such as catheters or infusion pumps.

Prior to a company marketing a medical device, it must be cleared or approved by the FDA. A new medical device can receive “approval” if the FDA finds that the applicant has provided reasonable assurance of the device’s safety and effectiveness. This is the most stringent standard applied by the FDA with regard to the marketing of medical devices, but it has weaknesses because it relies on the accuracy of the information provided to the FDA by the company that wants to sell the device. Alternatively, a medical device can receive “clearance” if the applicant shows that the device is “substantially equivalent” to another device that is already legally marketed for the same use, although the devices do not have to be identical.

In theory, receiving clearance from the FDA to market a medical device that is substantially equivalent to another device that has already received approval would seem to make it possible for consumers to have access to safe medical devices sooner. However, the medical device you trust is safe may have only received a superficial clearance based on the manufacturer’s representation of substantial equivalence.

As each new medical device deviates slightly from the one before it, but is still deemed “substantially equivalent,” decades can pass between the time the original device was approved and the time the medical device you use receives clearance. That means your medical device may bear very little similarity to the original medical device that was approved pursuant to a more stringent review for safety and effectiveness years earlier.

Just because a medical device received approval or clearance from the FDA does not necessarily mean it is safe. The FDA posts information on an ongoing basis about medical devices that are subject to recalls and safety communications as adverse events are reported by patients, physicians, and medical device manufacturers. Some of the problems encountered with medical devices are minor, but some can lead to serious injury or even death.

Rather than trying to protect patients who have to trust that the medical devices they use are safe, the United States House of Representatives Energy and Commerce Committee is supporting legislation that would make it easier for medical devices to receive clearance. The Committee says it is worried about the delay in getting medical devices to patients while they undergo review by the FDA. But wouldn’t you prefer for the FDA to thoroughly evaluate the safety and effectiveness of a medical device rather than allow you to use it, only to find out later that it wasn’t safe? Do you want to be the test patient without giving your consent?

The Committee says that the current FDA process for approval and clearance of medical devices is causing manufacturers to move overseas where there may be less oversight, supposedly resulting in the loss of jobs to Americans and making it so that medical devices are available in other countries but not in the United States. Even if that is true, is that so bad? One of the great things about living in the United States is that this country cares about the safety of its citizens in a way that many other countries do not. Do you really want to use a medical device that is manufactured by a company that is trying to avoid FDA review of its safety and effectiveness?

If you were injured by a defective medical device, you can check the FDA website to see if it was subject to a recall or safety communication, and you should discuss your injury with an attorney as soon as possible to determine whether there is a legal claim you can pursue.

Originally posted at InjuryBoard by Nicole Greer