More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.
The national law firm, Parker Waichman LLP, filed the lawsuit on behalf of the patient and against Boston Scientific Corporation; the woman alleges that she was implanted with the Boston Scientific Advantage Transvaginal Mid-Urethral Sling System in July 2006. She received the mesh to treat her pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the two conditions for which the device is approved. The lawsuit also alleges that Boston Scientific’s transvaginal mesh caused her to suffer from an array of adverse effects, such as significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity, and loss of bodily organ system.
According to the lawsuit’s allegations, Boston Scientific’s mesh is defective and exposes patients to an unreasonable risk of vaginal erosion, infection, extrusion, perforation, chronic pain, and/or abscess. Because it is not inert, the mesh, according to the lawsuit, reacts with the body’s tissues and can lead to adverse effects on patients’ health. The transvaginal mesh implant is also poorly designed in shape, weight, and other properties, making it inappropriate for use in the female pelvis, the lawsuit alleges. Boston Scientific knew, or should have known, that its transvaginal mesh implants carry these risks; instead of warning users, the manufacturer continued to market the faulty device, the lawsuit further alleged.
Last July, the U.S. Food and Drug Administration (FDA) issued a Public Health Notification warning that risks associated with transvaginal mesh are “not rare.” The agency pointed out that while these devices may pose additional risks, there is little evidence to support their benefits versus non-mesh methods. The notice was based on 2,874 reports of complications received between 2008 and 2010.
In January, the FDA asked a number of manufacturers, including Boston Scientific, to conduct post-market studies assessing the impact of transvaginal mesh implants on organ damage and other health issues.
Parker Waichman LLP represents numerous women who have fallen victim to the defects of transvaginal mesh devices. Each lawsuit shares similar complaints; that these and other transvaginal mesh devices were not properly tested before being used in surgery. Transvaginal mesh products have been alleged to cause myriad injuries likely to cause life-altering injuries requiring numerous revision repair surgeries with no promise that the surgeries will completely remedy injuries incurred from the first surgery.
Transvaginal mesh devices were approved through the FDA’s 510(k) “fast-track” approval system in which little or no comprehensive pre-market safety testing is required, which is based on the theory that the fast-tracked products are similar in design to other, approved surgical products. While mesh devices have been used in surgery before, they were never used in this application and the results of this haphazard approach have been disastrous for thousands of women. Transvaginal mesh devices are prone to erode through skin and the vaginal wall and have been known to cause extrusion, perforation, and abscess. They can also break apart, making surgery to remove the defective device even more dangerous, painful, costly, and complex. Pain, inflammation, and the risk of infection present themselves to women who suffer from the dangerous effects of these devices.
The lawsuit was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03126); the case was filed in the multidistrict litigation as part of the In Re: Boston Scientific Corporation, Pelvic Repair Systems Products Liability Litigation (MDL No. 2326).