Medical Device Division of FDA Broken, Needs Fixing

The FDA is having a meeting! This is progress, but not the kind of progress we victims, and the thousands of potential victims need.

It is imperative that the FDA suspends the use of all Class II devices that are internally implanted within one's body. Any device that is used as a permanent implant needs to be reclassified to a Class III device and be subject to INDEPENDENT clinical trials!

I was harmed by Ethicon’s Gynecare Tension Free Transvaginal Taping (TVT) System, of which Jane Akre wrote about in her articles "Suffering in Silence from a Medical Device - Surgical Mesh, Part one and Part Two.”

This device was approved under the FDA's 510K approval process, a flawed process by which a manufacturer of a Class II Medical Device only has to show their product is substantially equivalent to another product already on the market to obtain FDA approval. Approval in most cases is granted within 90 days, with no clinical trials being required.

Some Class II devices which fall into this category, are devices that are permanently implanted within one’s body. Surgical mesh used to “treat” hernia and incontinence issues fall into this category, and people are being irrevocably harmed as a result of this lackadaisical approval procedure.

The device by which I was harmed received FDA approval on January 28, 1998, and its approval number is: K974098. This is a polypropylene mesh product and it is petroleum-based. When I had it implanted in 2004, I was not made aware of the most serious complications: erosion of tissues and adherence to organs and/or nerve beds. I also was not told of other procedures where my own biological materials could have been used to correct my problem. Most important, I was not told of the 664 adverse events on file with the FDA on their MAUDE Database at the time immediately prior to my surgery, which would have allowed me to make an informed, educated decision as to whether or not I should proceed with the surgery. To date, there are nearly thirteen hundred (1300) adverse events on file, including my own.

Before my problems arose, I had never even heard of the MAUDE Database, and in conducting a multitude of research, I was able to determine that this database is not maintained in a uniform fashion.

In order to gain approval for the product implanted in me, the manufacturer cited substantial equivalence to the ProteGen Sling (called a predicate device) that was pulled from the market nearly a year later by its own manufacturer via a letter to the Food and Drug Administration on January 22, 1999. They cited complications with a "higher than expected rate of vaginal erosion and dehiscence," and further stated "and does not appear to function as intended."

It angers me that any device approved, using a predicate device as their substantial equivalent, would not too, be pulled from the market upon complications being cited with a said predicate device. The FDA formally recalled the ProteGen Sling on March 17, 1999, nearly two months after receiving the letter from the manufacturer to recall their product. Information regarding this manufacturer initiated recall can be found on the FDA Enforcement Report for March 17, 1999, under Class II Medical Devices.

Despite the fact that the ProteGen Sling was formally recalled, the FDA left on the market other devices that had used this device to gain approval. These products had no business being on the market in the first place. The FDA should never approve a device implanted within one’s body without it being subjected to Premarket approval, and clinical trials. A device that is permanently implanted, should be classified a Class III Medical Device. To maintain the integrity of the approval process, these clinical trials should be handled by an independent entity, not clinical trials overseen by the manufacturers themselves as often happens.

I want people who are considering having a mesh related surgery to be aware of the serious complications that your doctor probably won’t tell you about. It is up to all of us to be aware, believe me, I have been enlightened. Nine months ago, I never would have considered airing my personal business, but in the interest of saving another person from living the nightmare I have lived, I feel it is my duty to speak out regarding this issue.

Please, email me for more information at: aunt_sanner@yahoo.com

Mesh Victims, please consider joining Truth in Medicine, a mesh patient advocacy group committed to getting petroleum based surgical mesh products off the market, and seeing that the FDA receives an overhaul of the 510K Approval Process.

Jane said it is estimated that 2000 pelvic prolapse surgeries are done each month. This is 24,000 potential victims in one years time. This has got to be stopped!

Jane, Why would it take the FDA 19 years to act on such an important matter as to requiring safety evidence before a class lll device can be sold? If our Hospital took 19 years to change a method required by JACHO, we would not be accredited and would be out of business. If the FDA had assumed a more responsible position and had done what Congress had asked of them 19 years ago, people like Suzanne McClain and my husband would not have had to suffer the consequences of having a defective medical device implanted. The Medical Device Safety Act needs to be passed by the Congress and The Senate now to prevent more people from suffering due to the lack of FDA regulation.

I find it difficult to understand how it is not considered criminal that the FDA allows internal devices on the market without proper testing for safety. It also defies any logic that use of a device (like TVT Mesh) was not immediately stopped, when the device it was modeled after was pulled for being unsafe. Instead, its sale and use continued as if it were proven to be safe. I truly admire the scientists who felt approval was unwarranted in many cases and elected to speak out to alert the new Administration. I once thought that the FDA existed to protect the patients, but apparently the leadership of the FDA decided it is more important to benefit the manufacturer. Something is seriously wrong.