Tampa, FLOn the heels of hundreds of AMS Transvaginal Mesh complaints and class-action lawsuits against the transvaginal mesh manufacturers, including American Medical Systems (AMS), the FDA is finally considering additional research and is even considering a mandatory recall. While this is good news for some patients—their doctors will likely not recommend TVM procedure—it comes too late for too many women.
The FDA has received warnings about transvaginal mesh complications since 2008, when it released a Public Health Notification stating that the issues with the use of synthetic vaginal mesh was a growing concern. And just last month, the agency issued additional safety studies. It ordered 33 manufacturers—including AMS—of the vaginal mesh devices to conduct post-market safety studies on their products.
Diana (not her real name), who had AMS transvaginal mesh implanted two years ago for incontinence, is relieved to know that her problems are because of the failed mesh and not "in her head" as her doctor led her to believe.
On the other hand, she is furious that transvaginal mesh was approved by the 510(k) process, which means that a device can be cleared by the FDA without testing or clinical trials if a similar device is already on the market. The TVM case is particularly insidious because its approval was based on Boston Scientific's ProteGen, which was recalled due to safety complaints several years ago.
"I had incontinence issues for years and when it got so bad that I had leakage every time I exercised, laughed or coughed, I decided to have the TVM surgery," says Diana, age 56.
"On my gynecologist's advice, I had surgery at the University of Florida hospital, where they apparently specialize in these issues. I noticed some leakage around the catheter when I got home and soon as the catheter came out I was leaking again, so it was obviously a failure.
"Last May I had another TVM surgery with another type of mesh—this time AMS. And for almost a year I have been in constant pain. It hurts when I urinate, it hurts to have sex (for both of us) and I rue the day that I had this surgery without doing any research beforehand. Now I hear about all these problems from so many other women—and my doctor can't—or won't—do anything about it. It seems as though he is in denial, but if there is a recall…
"I filed a complaint with your attorney who has several other AMS vaginal mesh clients so maybe something will finally get done. I believe that the drug companies should take responsibility. And perhaps I can find another surgeon to remove this mesh."
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