The Food and Drug Administration is asking companies that manufacture transvaginal surgical mesh to do a three-year study of women implanted with the mesh. Such a study could not only affect women here in Ohio, but also throughout the country.
The FDA wants all 35 manufacturers of the dangerous medical devices to determine what side effects women have after doctors implant the mesh. Each company is supposed to track several hundred women for multiple years.
The FDA requested the safety studies after receiving more than 1,500 complaints about the dangerous products between 2008 and 2010. In some cases, the mesh reportedly caused infections and bleeding or eroded into patients’ vaginas.
Transvaginal surgical mesh is used help women suffering from pelvic organ prolapse, where weakened or damaged vaginal tissue allows pelvic organs to sag into the vagina. Roughly 30 to 50 percent of women may have some POP and about 2 percent have problems.
Surgical mesh, which can be made of synthetic or biological material, is also used to help women with stress urinary incontinence. Women with the problem have overactive bladders. The FDA wants additional studies on the use of mesh to form a “mini-sling” around the bladder neck and urethra to treat the condition.
Surgical mesh has been around since the 1950s. Its primary use was to repair abdominal hernias until the 1990s when doctors found it worked well for treating POP and stress urinary incontinence.
Because surgical mesh has been in use for so long, companies making it specifically to treat urinary incontinence or POP were able to use an accelerated FDA application process. If they could show their mesh was similar to devices already on the market, they did not have to do clinical trials in people.
The FDA is now considering reclassifying the devices so that manufacturers would have to conduct clinical trials in people before they could sell their products.
Source: Reuters, “FDA wants new studies on surgical mesh implants,” Anna Yukhannanov, Jan. 5, 2012.