FDA Responds to Transvaginal Mesh Complications

The FDA is finally considering additional research into the transvaginal mesh manufacturers and a mandatory recall may be in the future. There have been hundreds of complaints and class-action lawsuits against the transvaginal mesh, including the American Medical Systems (AMS) mesh.

While doctors may not be recommending this procedure for their patients any longer, this news comes too late for many women that have already had the procedure done.

There is a documented case of a woman in Florida who had an AMS vaginal mesh implanted a couple of years ago. She experienced several problems with the device but her doctor told her that it was all in her head. She has now learned that her problems were because the device failed.

This transvaginal mesh was approved by the FDA by means of the 510(k) process. This means that if a similar device is already on the market a device can be cleared by the FDA without testing or clinical trials. This case is interesting because the original device that was approved was later recalled several years after the fact.

There are various reasons why women have had transvaginal mesh’s implanted. But the hundreds of ensuing lawsuits are proving that the problems outweigh the benefits. The woman mentioned above, received the mesh because she suffered from incontinence for years. After that failed she had the AMS mesh inserted and was in constant pain for almost a year. She has since filed a lawsuit and hopes to find a surgeon that will remove the mesh.

If you or someone you know is suffering because of a transvaginal mesh complication, please contact the Zevan and Davidson Law Firm by calling (314)588-7200 or by filling out our online contact form for a private and confidential consultation. We fight for women who have been victimized by faulty vaginal mesh designs and implantations. We make sure that our clients are duly compensated for their physical and emotional pain.

photo credit: crucially