Gynecare mesh systems are medical devices specially designed to treat severe cases of pelvic organ prolapse (POP); the surgical mesh is marketed as a POP repair system that is placed inside the pelvis to help restore organ support and prevent future organ prolapse. Products like the Johnson & Johnson Gynecare Prolift were introduced and widely marketed to POP patients as a possible treatment option despite having never conducted any clinical trials testing the device. Although it was initially believed that the use of a surgical mesh helped increase the success of a POP surgery, after thousands of reports of injuries and months of investigation, the FDA issued an official notice warning patients that serious side effects from a POP surgery using a mesh such as Gynecare is not rare. Victims of dangerous side effects are encouraged to consult a Gynecare transvaginal mesh injury lawyer who can help potential claimants determine their rights to compensation.
Transvaginal Mesh FDA Approval
In 1998, Johnson & Johnson also won FDA clearance to market and sell Gynecare transvaginal systems through the 510(k) route, a loophole in FDA regulation that allows medical device manufacturers to bypass clinical testing before receiving FDA approval. Within a few years, thousands patients reported serious medical complications related to the use of a transvaginal mesh, and Boston Scientific, another medical device manufacturer, settled 738 lawsuits over its vaginal mesh device. Since 2005 to 2010, the FDA has received more than 4,000 reports of complications such as:
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring or shrinkage
- Vaginal bleeding
- Recurrent pelvic organ prolapse
Problem of Mesh Contraction and Erosion
The FDA’s literature review found that mesh erosion through the vagina is the consistently reported mesh-related complication from transvaginal POP surgeries. Mesh erosion, exposure, extrusion, or protrusion through the vagina can cause severe pain, infection, organ perforation, urinary problems, as well as pain during sexual intercourse. Because the transvaginal patch is designed to meld with the native tissue, in some cases, even multiple surgeries cannot repair the complication related to mesh erosion or contraction.
FDA Warning Against Surgical Mesh for POP Surgeries
Due to the large number of injury reports, the FDA conducted a literature review of all the scientific papers published from 1996 to 2011, and investigated the safety and effectiveness of transvaginal mesh POP operations. In conclusion, the FDA noted that products like Gynecare introduces dangers not present in traditional POP surgeries. In addition, there was no symptomatic difference between surgeries that implemented transvaginal mesh devices and those that did not. Based on the complications described in medical literature and the updated analysis of adverse events reported to the FDA, transvaginal mesh POP repairs are a serious public health concern.
Johnson & Johnson Transvaginal Mesh Lawsuit Lawyers
Approxmiately 200,000 women receive POP repair surgeries every year, many of whom received a Gynecare pelvic organ support system that has caused severe complications within a few years of treatment. If you have been seriously harmed after receiving a Gynecare pelvic support system, make sure your legal rights are protected. The Gynecare injury lawyers at Estey Bomberger can help you recover the maximum compensation you deserve for your injuries.