Johnson & Johnson’ Ethicon unit is facing a number of lawsuits over its Gynecare Prolift product, a newer type of <"http://www.yourlawyer.com/topics/overview/transvaginal_mesh_injuries">transvaginal mesh being used in pelvic organ prolapse repair (POP) surgery. According to a report from ABC News, more than 100 lawsuits have been filed by women who claim Gynecare Prolift transvaginal mesh has caused them to suffer from urinary incontinence, pain, infections and other debilitating complications
“It’s horrible. There are unknown amounts of the mesh still in me. I have extreme pain. It feels like the inside of my vaginal wall is on fire,” Linda Gross, 46, a plaintiff in a Gynecare Prolift lawsuit, told ABCNews. “I wouldn’t wish this on anyone.”
Gross was implanted with Gynecare Prolift transvaginal mesh in 2006. Today, she can’t sit for more than 20 minutes, is unable to have sex with her husband, or remain active for more than a few minutes at a time, ABC News said.
Gross and other Gynecare Prolift plaintiffs have charged Ethicon with negligence and designing a defective product. They are seeking compensatory and punitive damages, ABC News said.
Like other transvaginal mesh products, Gynecare Prolift was approved through the U.S. Food & Drug Administration’s (FDA) 510(k) clearance process. This less-stringent process is allowed for medical devices that are shown to be substantially equivalent to devices already on the market. The 510(k) process, which has long been criticized as being too lax, does not require manufacturers to run human clinical trials.
For its 510(k) approval, Prolift was compared to Gynemesh, a similar mesh product sold by Johnson & Johnson since 2002, ABC News said. Gross’ lawyer pointed out to ABC News that Prolift didn’t receive its 510(k) approval for POP until 2008, which he said means the device she and others received may have been sold without FDA clearance.
Prolift is just one of many transvaginal mesh devices currently on the market that have been associated with serious complications. As weâ€™ve reported previously, the FDA said in a July safety communication that it has received more than 1,500 reports of serious complications – including several deaths – associated with the use of transvaginal mesh in POP surgery since 2009.
According to ABC News, the most common problem with transvaginal mesh is that it can begin to erode within months of being implanted and pieces of the mesh may dip down into the vaginal canal. According to the FDA, erosion occurred in 35 percent of all adverse events. Other adverse events reported to the agency included pain, 31 percent of the time; infection, 16 percent; and bleeding, 8 percent.
One surgeon who spoke to ABC News said many complications are the result of the “arms” on the transvaginal mesh that must pass through several structures in the pelvis. According to the surgeon, if the arms are implanted in an overly taut manner, they may pull on the groin muscles, causing pain. Often transvaginal mesh complications require that victims undergo additional surgeries, but because it is difficult for a surgeon to remove all of the mesh from a patient’s body, surgery may not resolve all problems.
Late last month, an FDA staff report proposed reclassifying transvaginal mesh devices for POP surgery from moderate risk, Class II, to the highest-risk category for medical devices, Class III. That would mean they would be ineligible for 510(k) clearance, and manufacturers would need to conduct clinical trials in order to have them approved for that use. Last week, during a two-day meeting to investigate the safety of transvaginal mesh in POP repair, a panel of FDA advisors backed that plan. While no formal vote was taken, a majority of the panel also backed the agencyâ€™s proposal that manufacturers conduct postmarket studies of devices currently on the market.
The FDA is not legally required to follow the recommendations of its advisory panel, but does so in most cases.