FDA: Johnson and Johnson Marketed and Sold Dangerous Mesh Without Approval

The government has reported that Johnson and Johnson allegedly marketed and sold a dangerous vaginal mesh product for three years before it was approved by the U.S. Food and Drug Administration (FDA). According to Bloomberg, J&J’s Ethicon unit released the Gynecare Prolift vaginal implant in March, 2005, but it was not approved until May, 2008. The company invoked a process called 510(k), in which products can be released without approval if they are extremely similar to products already released. The FDA said that did not apply in this case, concluding that marketing and sale of the product began “without appropriate” clearance.

Once the mesh is installed though, it sometimes contracts and the complications of this can be comparable to those of the original condition.

Under the 501(k) system, companies simply need to cite similarity to an already approved device, called a “predicate” by the FDA. Johnson and Johnson used Boston Scientific’s ProteGen vaginal mesh as its predicate. Reportedly, J&J was allowed to skip human testing because its device was “substantially equivalent” to the previous device. Before the release of J&J’s Gynecare TVT mesh, Boston Scientific voluntarily recalled the ProteGen mesh, citing unintended dangers. Remarkably, J&J, American Medical Systems and Covidien Plc (COV) were still permitted to release products modeled directly after Boston Scientific’s product. Over 500 women have filed lawsuits have claiming that transvaginal mesh was faulty and prone to complications that could lead to extremely painful and potentially serious adverse physical effects.

Mesh is commonly surgically inserted into the vagina to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when the structures that hold the pelvic organs become so weak or stretched that the organs move from their original position and prolapsed into the vagina. Once the mesh is installed though, it sometimes contracts and the complications of this can be comparable to those of the original condition. The adverse physical effects due to the contraction of the mesh are varied, including vaginal shortening, bleeding, scarring, infection, erosion, perforation, tightening and significant pain. In July, the FDA concluded reported that there is not conclusive evidence that the use of transvaginal mesh to repair POP is a more successful method than alternative non-mesh procedures.

The adverse effects and complications associated with transvaginal mesh are serious, and victims may experience considerable physical, emotional and financial hardships as a result of this surgical procedure. Multiple manufacturers are the subject of lawsuits alleging that they knowingly manufactured and marketed dangerous products, and this new report of illegal sales will likely help the case of injured women. If you or a loved one has experienced the adverse effects associated with vaginal mesh, contact a knowledgeable transvaginal mesh attorney by completing the form on the right to find out if you can pursue legal recourse and work to receive compensation for your pain and suffering, lost wages and medical bills.