Product News and Recalls

Bloomberg: J&J sold mesh implant before FDA approval

According to a Bloomberg report, Johnson & Johnson sold a vaginal mesh implant for three years before the federal Food and Drug Administration approved the device.

The report says Johnson & Johnson introduced the Gynecare Prolift device in March 2005 without appropriate clearance. The FDA learned of the device in 2007 when Johnson & Johnson was trying to get approval for a related device.

The FDA approved both devices in 2008, after Johnson & Johnson took advantage of a loophole that obliges the agency to fast-track new devices based on their alleged similarity to ones that are already on the market, even if they’ve never been tested on humans.

At the time of the approval, the FDA already had more than 100 complaints about the ProLift device recorded on its database of reported malfunctions, deaths or serious injuries.

The report quotes Andrew Sokol, an associate professor of obstetrics/ gynecology and urology at the Georgetown University School of Medicine, as saying: “That information would have been important for most surgeons. Most surgeons probably would have not used a completely new product if there was no oversight.”

Surgeons use vaginal mesh implants to treat incontinence or help women with pelvic organ prolapse, a condition in which weakened muscles fail to support internal organs. An FDA report in July found a five-fold jump in deaths, injuries or malfunctions related to vaginal mesh for prolapsed organs.

In September, an advisory panel urged the FDA to reclassify such mesh as “high-risk” devices needing human testing. In January, the FDA said Johnson & Johnson and other makers must study organ damage and complications related to the products.

The most common complications from transvaginal mesh implants are vaginal mesh erosion (also known as exposure, extrusion or protrusion), pain, infection, urinary problems, bleeding, and organ perforation. Also reported were recurrence of prolapse, muscular problems, vaginal scarring and mesh contraction, which causes a host of problems. Numerous lawsuits have been filed over these complications, in part because studies show no benefits over non-mesh repair.

If you had a mesh implant and suffered one of the above symptoms, contact Lopez McHugh to discuss your options for pursuing compensation, or have your questions answered by a qualified attorney, with no obligation.

We have female attorneys standing by, available to discuss your specific situation and answer any legal questions you may have. Your initial consultation is free and there is no obligation. Call today because if you wait too long, you may be barred from recovering for your injuries by your state’s time limits.

Additional details about transvaginal mesh are available here.

See the report here: http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2012/03/21/bloomberg_articlesM1783M0UQVI901-M17S7.DTL