More victims of <"https://www.yourlawyer.com/search">transvaginal mesh have filed lawsuits alleging the devices caused serious and painful complications following surgery for pelvic organ prolapse (POP) repair. According to a report from Bloomberg News, Johnson & Johnson has been named in roughly 270 transvaginal mesh lawsuits. Other manufacturers, including C.R. Bard and American Medical Systems, have also been named in claims.
Marci Sutin Levin, who underwent POP surgery with transvaginal mesh in 2007, is among those who have filed suit against Johnson & Johnson. She told Bloomberg that the pain she has experienced since her procedure is worse than childbirth.
“The pain of childbirth was finite, and you’re delivering a child,” she said. “This was very, very different. It’s relentless, and it’s untenable. And it doesn’t lead to anything.”
Levin claims that Johnson & Johnson did not subject the transvaginal mesh product she received to enough testing before it was brought to market.
Levin is just one of the 75,000 women a year who undergo surgical POP repair that involves transvaginal mesh. As we’ve reported previously, the U.S. Food & Drug Administration (FDA) classifies these devices as “moderate risk,” and approved them under its much-maligned 510(k) process. Approvals under 510(k) protocols generally do not require human testing, and are used when a manufacturer can show a product is similar in design to devices already on the market.
The FDA has warned twice that use of transvaginal mesh had been tied to serious complications, including mesh erosion, infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence. According to its latest warning in July, the FDA has received more than 2,800 complaints about transvaginal mesh complications since 2009. Of those, more than 1,500 were associated with POP repair, and three involved fatalities. The July alert also raised doubts as to whether transvaginal mesh devices offered any additional benefit over other procedures.
According to Bloomberg, an FDA review of 110 studies that examined mesh in 11,785 women showed 10 percent had erosion within a year. Seven deaths were also reported, including four due to medical complications not directly related to the mesh placement procedure.
As concerns over the mesh products have grown, so has agitation for a recall. As we reported previously, the influential consumer advocacy group, Public Citizen, petitioned the FDA for a transvaginal mesh recall just last month.
The FDA is worried enough that starting today, it is convening a two-day meeting of its Obstetrics-Gynecology Devices Panel to determine whether transvaginal mesh for POP repair is safe and effective, and whether makers must submit more safety data to keep their products on the market. A report prepared in advance of that meeting by FDA staff has gone so far as to call for the revocation of 510(k) clearance for transvaginal mesh devices used in POP repair. The FDA staff report goes on to state that the “rate and severity of mesh-specific adverse events following vaginal POP repair with mesh calls into question the safety of these devices.”
According to Bloomberg, the FDA’s advisory panel won’t be taking a formal vote on any recommendations when its two-day hearing wraps up. However, an agency spokesperson told Bloomberg that the panel will be polled on whether to reclassify the devices and gather thoughts on how to conduct clinical studies. It’s not known when the FDA will make a final decision on transvaginal mesh.
