Transvaginal mesh patches are devices that are surgically implanted along the vaginal wall to help support tissues that might otherwise not stay in place due to such things as childbirth or hysterectomies. However, transvaginal mesh patches have been linked to infections, erosion of the pelvic lining, severe pelvic pain and perforation of the bowel or bladder. Thousands of women have filed lawsuits against the manufacturers of these patches alleging they have been harmed.
If you have had a transvaginal mesh patch surgically implanted and suspect that you have suffered an adverse reaction, you can find out if you may participate in a class-action lawsuit by clicking the Join button on Medical Lawsuits site. Information you provide will be forwarded for an evaluation to see if it might qualify for participation in legal action.
In June 2012, Johnson & Johnson announced it was pulling four of its transvaginal mesh products from the market. That same month, Elizabeth Matthews of New Jersey filed suit against Johnson & Johnson and its subsidiary, Ethicon Inc., in the Superior Court of New Jersey. She alleges that she suffered internal injuries and has ongoing medical problems as a result of having Ethicon's Gynecare Prolift and TVT Secur products surgically implanted in her in 2007, according to the Lanier Law Firm, which represents her.
Mesh patches, which are manufactured by several companies, also can help with pelvic organ prolapse (POP), in which such body parts as the bladder, uterus, bowels, vagina, urethra or rectum might move out of place because the pelvic floor is not capable of holding them in the correct position.
In addition, the patches are used to help treat stress urinary incontinence (SUI), which is a condition that affects some women who suffer from accidental urinary leaks when they cough, sneeze or laugh. This condition is not uncommon in women who have given birth.
In October 2008, the U.S. Food and Drug Administration issued an alert that warned doctors and patients about potential problems associated with the transvaginal mesh patch when used for POP and SUI. At that time, the FDA had gotten more than 1,000 reports regarding nine manufacturers of these mesh devices.
The FDA recommended that doctors get special training for mesh placement, be aware of the risks and watch closely for any problems, tell patients about the possibility of severe complications, inform patients the mesh is permanent and explain that they might need more surgery if complications arise and, when possible, provide patients with a written copy of the patient labeling from the manufacturer.
In July 2011, the FDA provided an update to health care providers and patients stating that "serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008."
The FDA stated: "The number of adverse events reported to the FDA for surgical mesh devices used to repair POP and stress urinary incontinence (SUI) for the previous 3-year period (2005 – 2007) was 'over 1,000.' Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, the agency is concerned that the number of adverse event reports remains high."
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." The FDA said it will keep on analyzing the effects of the mesh and issue future updates as new information becomes available.
Johnson & Johnson has manufactured transvaginal mesh patches, as did many other companies, which were surgically implanted into a woman to correct problems with tissue that will not stay in place. However, many patients have alleged that the patches caused infections, severe pelvic pain and other health problems.