J&J's Ethicon to Judge: We Will Stop Selling Gynecare Vaginal Mesh

Johnson & Johnson and its subsidiary Ethicon have told a judge in West Virginia that they will cease marketing, production, and sales of four problematic transvaginal mesh implants. According to Businessweek, this announcement comes after over 600 women have sued the companies and over 1,500 complaints have been made to the U.S. Food and Drug Administration (FDA) about the product. The massive pharmaceutical company will stop selling the Gynecare Prolift, Prolift+ M, TVT Secur and Prosima vaginal mesh systems. Ethicon has requested to continue sales of the Gyencare Gynemesh.

The complications associated with transvaginal mesh implants are serious.

Last summer, the FDA concluded that there was not conclusive evidence that the use of mesh to repair POP is more successful than alternative non-mesh procedures. In January, the FDA ordered manufacturers to study the possible adverse effects of vaginal mesh implants. Recently, the FDA announced that Johnson and Johnson had allegedly marketed and sold vaginal mesh for three years before it was approved. 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.

Vaginal mesh is commonly used to treat a condition called pelvic organ prolapse (POP), where a patient’s inner pelvic organs slide downward and forward to the point of prolapsing into the vagina. Transvaginal mesh has often caused extremely painful and serious side effects, sometimes mimicking the exact problems it was meant to fix. Transvaginal mesh is known to commonly cause stress urinary incontinence (SUI) due to pressure on the bladder, as well as general pain and discomfort, mesh erosion through the vagina, infection, urinating problems, organ perforation, bleeding, interference and pain with sexual intercourse, and mental distress. Millions of women have had vaginal mesh surgically implanted.

The complications associated with transvaginal mesh implants are serious, and victims may experience considerable physical, emotional, and financial hardships as a result of this surgical procedure. Johnson & Johnson, as well as manufacturers such as American Medical Systems, Inc. and Boston Scientific Corp. (BSX), are alleged to have knowingly manufactured and marketed dangerous products, and thus can be held liable for injuries caused as a result. If you or a loved one has experienced painful complications due to vaginal mesh implants, fill out the no-obligation form on the right for more information regarding your legal options. You may be eligible to pursue legal recourse and work to receive compensation for your pain and suffering, lost wages, and medical bills.