Endo International has agreed to aside an additional $775 million to resolve the remaining lawsuits alleging the company’s vaginal-mesh implants caused serious and sometimes permanent injuries in some recipients.
Filings with the U.S. Securities and Exchange Commission reveal that Endo has set aside more than $2.6 billion to settle claims related to the defective vaginal mesh devices, Bloomberg reports. Dublin-based Endo has shut down a unit that makes transvaginal mesh implants.
Transvaginal mesh is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). SUI and POP occur when the pelvic structures that support a woman’s uterus, bladder and intestines weaken due to childbirth, surgery, or aging. The organs drop (prolapse) into the vagina, causing incontinence and bowel and sexual problems. These devices are based on the surgical mesh patches used since the 1950s in hernia surgery. Before transvaginal mesh came to market, surgery for POP and SUI involved creating support for the organs using the woman’s own tissues.
National law firm Parker Waichman notes that a number of transvaginal mesh manufacturers face lawsuits from women who blame the devices for their injuries. Ethicon, Boston Scientific, C.R. Bard, Cook Medical, Coloplast, and American Medical Systems have been named in lawsuits over injuries and complications from their transvaginal mesh products.
Transvaginal Mesh Complications
Women who have filed transvaginal mesh lawsuits allege they have suffered serious and painful complications including mesh protrusion (erosion) into the vagina, infection, inflammation, scar tissue, organ perforation, painful intercourse, urinary and bowel incontinence, and nerve damage. Many of the lawsuits allege that the manufacturers failed to warn the women and the medical community about potential complications.
Many women have needed additional surgery to attempt to remove the mesh and repair organ damage. These surgeries, however, are not always successful. Some women have been caught in a cycle of repeated episodes of mesh erosion and surgery to remove protruding mesh.
More than 100,000 transvaginal mesh lawsuits have been filed, and about 75 percent of mesh lawsuits are consolidated in West Virginia federal court through seven multi-district litigation (MDL) cases. The remaining cases are in state courts. Other mesh device makers still face thousands of claims in the U.S. and worldwide.
The U.S. Food and Drug Administration (FDA) approved many transvaginal mesh devices the 510(k) device clearance process. The 510(k) process allows manufacturers to bring devices to market more quickly if the proposed device is deemed substantially similar to a device already on the market and performing well. Devices brought to market through 510(k) avoid the rigorous clinical testing and trials that a device of new and unique design is required to undergo. Some medical experts say all devices, especially those that are implanted in the body, should be required to undergo clinical trials to establish their safety and effectiveness. Even small differences in materials or design can have major impact on how a device functions or on its safety.
Thousands of women have reported transvaginal mesh injuries and complications to the U.S. Food and Drug Administration (FDA). In a 2011 safety communication for women and health care providers, the FDA said serious complications associated with transvaginal mesh “are not rare” (FDA emphasis). Further, the agency said, it is “not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” Many of the injured women say that if they had been aware of the risk of serious and possibly permanent injuries they would have chosen the older surgical technique.
In January 2016, in response to thousands of lawsuits and reports of mesh failure and complications, the FDA issued two orders for transvaginal mesh devices. The first order reclassifies vaginal mesh devices from Class II, the moderate-risk device category to Class III, the high-risk category. The categories are assigned depending on how likely it is that a particular device will cause serious and permanent health consequences or even death. The second FDA order requires vaginal mesh manufacturers to submit premarket approval (PMA), the most stringent type of device marketing application required by the FDA.
Help for Women Who Have Suffered Transvaginal Mesh Injuries
If you or a woman you know has suffered injuries or complications from a transvaginal mesh device or have undergone additional surgery to remove the mesh or repair organ damage, the attorneys at Parker Waichman LLP can evaluate your legal options. For a free, no-obligation consultation, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).