FDA Requires Manufacturers to Study Surgical Mesh Risks

The Food & Drug Administration has required the makers of transvaginal surgical mesh, used to treat complications of pelvic organ prolapse, to study the risks associated with the medical device, according to the New York Times.

The move comes after the FDA earlier reported the number of adverse events associated with surgical mesh devices has increased fivefold from 2008 to 2010.

Transvaginal surgical mesh, like DePuy ASR and Pinnacle hip replacements, is an implantable medical device. There is no law requiring that these kinds of medical devices be studied and tested before being marketed to physicians and their patients. Instead, the FDA issues an order for manufacturers to study the devices after consumers experience serious complications.

This means that a number of women who underwent transvaginal POP repair with surgical mesh were unaware of the seriousness of the complications of the procedure.

Complications associated with transvaginal mesh include infection, painful sexual intercourse, urinary problems, and overall discomfort and bleeding, all caused by the mesh eroding through tissue or the skim contracting too tightly around the device.

The FDA estimates that about 100,000 women a year with pelvic organ prolapsed are treated with the plastic mesh. The irony is that the medical condition can most often be treated without mesh and thereby avoiding the increased risked associated with the medical device.

“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said Dr. William Maisel, chief scientist of the FDA division that oversees medical devices, in a TVM press release. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.”

The top producers of vaginal mesh, which will be responsible for studying the risks associated with these medical devices, include Boston Scientific, C.R. Bard, Ethicon and W.L. Gore & Associates.

Learn more about transvaginal surgical mesh.

 

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