Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a woman who suffered injuries after receiving transvaginal mesh implants. The lawsuit suit alleges that the transvaginal mesh created an unreasonable risk and directly caused her injuries.
The lawsuit was filed June 8th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-01954) and names as defendants American Medical System, Inc., Analytic Biosurgical Solutions, Mentor Corporation, Johnson & Johnson, Ethicon, Inc., Coloplast A/S, Coloplast Corporation, Coloplast Manufacturing, and others, which designed, manufactured, or marketed the device.
The woman claims that, in March 2007, she was implanted with the Perigee System with IntePro, the Apogee System with IntePro, and Mentor Aris Trans-Obturator Tape to treat her stress urinary incontinence (SUI) and pelvic organ prolapse (POP). These devices are intended and approved for both conditions. The lawsuit also alleges that she suffered from significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity, and loss of body organs as a result of being implanted with these defective devices and has undergone or will be required to undergo at least one corrective surgery, according to the complaint.
Transvaginal mesh devices were approved via the U.S. Food & Drug Administration’s (FDA) controversial 510(k) process, under which new medical devices can be fast-tracked if they are proven to be substantially similar to an existing, approved medical device. This process does not mandate a formal approval review, among other issues.
Transvaginal mesh implants pose dangerous risks due to a number of defects; the material used in these defective products reacts with and abrades human tissues, harbors infections, becomes embedded, and is inappropriately designed for use in the female pelvis, the complaint states. The defendants are accused of misrepresenting the products as safe and effective.
In 2008, the FDA issued a Public Health Notification in response to over 1,000 reports of complications linked to transvaginal mesh, noting that side effects appeared serious, but rare. Reports included erosion, pain, infection, bleeding, pain during intercourse, organ perforation during placement, and urinary problems. Then, last July, the FDA announced that it received another 2,874 reports associated with the devices and indicated that the complications are “not rare,” and noted that it is unclear if transvaginal mesh provides any benefit over non-mesh procedures and may expose patients to greater risks. Last September, the FDA’s Obstetrics and Gynecology Devices Advisory Panel recommended that transvaginal mesh implants be reclassified from moderate to high risk. This new designation would eliminate the product’s ability to go through the 510(k) process and mandate clinical evidence to supports its safety and efficacy. Also, in January, the FDA asked 33 manufacturers to conduct post-market studies assessing the impact of transvaginal mesh on organ damage and other related issues.
Meanwhile, Johnson & Johnson recently announced it would stop selling four transvaginal mesh products—Prolift, Prolife + M, TVT Secur, and Prosima systems. According to Bloomberg, the devices are expected to be off the market by the first quarter of 2013. The company has also asked the FDA for 120 days to inform its consumers and healthcare professionals about the decision.
The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation now underway in federal court in West Virginia. Ethicon and Johnson & Johnson have been named in roughly 600 lawsuits currently pending in the multidistrict litigation in U.S. District Court, Southern District of West Virginia before U.S. District Judge Joseph R. Goodwin who is also overseeing multidistrict litigation involving similar lawsuits that name transvaginal mesh products sold by American Medical Systems, Boston Scientific, and C.R. Bard.
More than 75,000 women a year have transvaginal mesh devices implanted to treat SUI and POP. According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.