Representatives from several manufacturers of controversial transvaginal mesh surgical devices told FDA officials at a panel meeting last month that they agreed further testing of the devices and label warnings may be warranted.
The concessions followed an FDA warning on July 13, 2011 that use of the devices in pelvic organ prolapse surgeries could cause more side effects than other surgical methods.
Based on clinical results, the FDA had recommended that the devices be reclassified as high risk and face even more regulatory controls. However, the manufacturers argued that these steps would place an undue burden on makers and slow supply of the much needed medical devices.
Between 2005 and 2010, the Food and Drug Administration received approximately 4,000 reports of side effects or complications from women who received transvaginal mesh implants to correct conditions like pelvic organ prolapse.
Recent studies have also shown that more than 15% of women receiving the devices have encountered vaginal mesh erosion within only 3 months of their surgery. Other complications can include punctured bowels or bladders, infection, bleeding, pain during intercourse, urinary problems and vaginal bulging or scarring.
At least nine companies have been named as manufacturers of the maligned devices, among them Johnson & Johnson’s Ethicon unit, C.R. Bard, Tyco, Boston Scientific, Gynecare and Endo Pharmaceuticals Holdings.
Experts estimate more than 75,000 women underwent procedures to implant transvaginal mesh devices in 2010 alone.
While the FDA will meet with physicians and advisors before reaching a decision, it is highly anticipated that the transvaginal mesh devices will be allowed to stay on the market with new warnings.
To many in the drug safety regulation arena, the pending compromise is another example of the strength the pharmaceutical industry wields over the FDA.