The FDA is promoting injury to United States citizens with its lackadaisical manner in which it allows surgical mesh, a permanently implanted medical device to be approved under the 510k process. This approval process allows
We the undersigned wish to address the manner in which the FDA is approving surgical mesh for implantation into human beings under the 510K approval process in which no clinical trials are required. In doing so, the FDA is promoting injury to United States citizens and citizens of other countries.
This approval process allows for a manufacturer to simply submit a proposal to the FDA saying that their device is substantially equivalent to a device already on the market, (called a predicate device) and within 90 days the manufacturer receives approval to proceed to market with their new, or improved product. Under this approval process, absolutely no clinical trials are required. In effect, those of us who have been implanted become the clinical trials as we begin reporting adverse events to the FDA. We are the pharmaceutical companies guinea pigs.
The device I was implanted with, the Tension Free Transvaginal Taping (TVT) Device, manufactured by Ethicon, a subsidiary of Johnson and Johnson gained approval in this manner on January 28, 1998. The FDA approval number for this device is K974098, and Ethicon used the ProteGen Sling manufactured by Boston Scientific as its predicate (substantially equivalent) device to gain this approval.
When Boston Scientific elected to pull the ProteGen Sling from the market via a letter to the FDA on January 22, 1999 citing "Use of ProteGen in the treatment of female urinary incontinence is associated with higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended" the FDA did not choose to act immediately, but waiting until March 17, 1999 to formally pull the device from the market.
Herein lies the problem: once Boston Scientific pulled their device from the market, (again because it did not function properly) the FDA chose to leave on the market all of the products that had used this product as their predicate device to gain approval despite the fact that the predicated device proved to be faulty. Adverse events were/are being filed in which these subsequent devices are eroding tissues away, and/or becoming adhered to organs and nerve beds.
I have tied many surgical mesh devices if not directly, then indirectly back to the ProteGen by tracking the approval process for each through the FDA's website. The FDA's website is not uniform and proved tedious to research. I spent a year researching surgical mesh through the maze of the FDA's site as well as through other places, and have obtained mountains of documents/information pertaining to it, and to the detriments of implanting this in the human body .
The 510k approval process does have its place, the approval of topicals like gauze, band-aids, and tongue depressors, but should not include the lackadaisical manner in which the FDA is allowing permanently implanted devices to be approved for implantation in ones body. This practice is reprehensible, and the process must be changed.
To read the full four-part story on surgical mesh in which the FDA and the Experts weigh in, please go to www.injuryboard.com and type in my name, Suzanne McClain. All four articles, written by Ms. Jane Akre, the editor for the Injury Board and former CNN and Fox News Reporter is entitled "Suffering in Silence from a Medical Device-Surgical Mesh" yet I have been anything but silent.
I have repeatedly asked for a Congressional Hearing for myself and other mesh sufferers in which to address this issue, but my requests have been ignored. I ask that Congress seriously consider my request for a Congressional hearing, and allow us mesh sufferers to have a voice. Thousands are being injured by these type of devices.
Please ask yourselves, how long before someone I know, someone I love is injured physically and emotionally by surgical mesh. The resulting injuries are life altering
I sincerely thank you for your time in reading my letter, written on behalf of mesh sufferers Worldwide. We sincerely need your help.
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