U.S. health regulators have ordered more than 30 manufacturers of transvaginal surgical mesh products to conduct studies assessing their safety in procedures to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In letters mailed to Johnson & Johnson , C.R. Bard Inc. and 31 other makers of transvaginal mesh devices, the U.S. Food & Drug Administration (FDA) said it was “concerned with the potential safety risks” of the devices.
The FDA has been studying the safety of transvaginal mesh for several years now. This past July, the agency said in a safety communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs, representing a fivefold increase in adverse event reports related to such procedures. During the same period, the FDA received 1,371 reports of complications relating to SUI repairs.
Transvaginal mesh complications reported to the agency have included mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The FDA also said in its July communication that its review had not seen any evidence that POP repair with transvaginal mesh offered additional benefits compared to other treatment methods.
In September, a group of FDA advisors backed a proposal by agency staff to reclassify transvaginal mesh used for POP repair as a Class III (high risk) medical device. Currently, the devices are classified as moderate risk (Class II), making them eligible for the 510(k) approval process, which does not require human trials before a device is brought to market. The majority of advisors on the FDA panel also agreed that the agency should require the manufacturers of transvaginal mesh devices currently on the market to conduct postmarketing studies to assess their safety and effectiveness in POP repair.
According to a report from Bloomberg News, in its letter sent to transvaginal mesh manufacturers this week, the FDA requested that they collect as much as three years of data on the safety and effectiveness of the implants. However, according to The New York Times, the FDA’s order does not cover all uses of transvaginal surgical mesh to treat incontinence, as the agency believes that safety of such devices when surgically implanted through the abdomen is “well established.”
“We believe there are certain uses of mesh where we need additional data to help guide the clinical community,” William Maisel, deputy director of science for the FDA’s device-approval center, told Bloomberg “Our goal is to make sure the right women use it at the right time.”
According to a Wall Street Journal report, the FDA suggested companies design the studies in such a way that they could satisfy requirements for premarket approval applications for products that would be used in transvaginal POP procedures.
The FDA estimates that almost 300,000 transvaginal mesh devices were implanted in U.S. women in 2010 to treat SUI or POP. According to Bloomberg, the devices’ alleged failures have spurred more than 650 lawsuits against transvaginal mesh manufacturers,