• 12
  • December
    2011

Since the 1970s, doctors have been using surgical mesh for conditions such as pelvic organ prolapse (POP). For women suffering from POP, the mesh products were Food and Drug Administration-approved surgical devices designed to alleviate problems of muscle support and pain, as well as bowel- and bladder-related problems. However, urogynecologic mesh makers, such as Johnson & Johnson and Bard, are facing mounting litigation and the Food and Drug Administration (FDA) has again come under scrutiny.

Prolapses occur when supporting pelvic muscles weaken or stretch, causing associated organs to slide out of place. When traditional treatments-including pessaries-fail, surgery may be necessary. Surgical mesh reinforcement, performed abdominally or transvaginally, is a common treatment option and has been known to help some patients. In July 2011, the FDA warned that transvaginal placement of mesh devices increases the risk for patient complications and injury.

From 2008 to 2010, the FDA received over 1,500 additional adverse event reports regarding urogynecologic surgical mesh devices. The increased complaints were five times more than previously reported from 2005 to 2007. This past summer, the FDA's warnings specified transvaginal placement. In 2010, nearly 100,000 POP surgeries were performed in the United States, and approximately 75 percent of these procedures were performed transvaginally.

With a growing number of lawsuits filed against mesh makers, The FDA has announced that it will work toward improving the safety and effectiveness of urogynecologic mesh products; however, many of the injured claimants have implicated the FDA and its 501(k) fast-track device review process in their suits. The review process does not require consumer testing on new products where a similar or predicate device has been previously approved.

This practice came under attack after an Institute of Medicine audit deemed that the process was seriously broken and should be discarded. At the center of the storm is the FDAs continued approval of vaginal mesh devices based on the 1996 clearance of ProteGen. Other companies used ProteGen as its predicate device, in spite of the fact that it was almost immediately pulled from the market.

Based on various reports received by the FDA, patients had experienced pain and bowel and bladder perforation, as well as requiring additional surgeries and treatment for abscesses. For those injured by defective medical devices, personal injury and product liability claims are remedies.

In the absence of proper safety testing, medical devices have a dark side. Unless new and effective methods are fashioned to ensure medical product safety, consumers will remain at risk for serious injuries.

Source: Johnson & Johnson vaginal mesh lawsuits another blow to the FDA's device review process