Surgical Mesh Claims and Lawsuits

Surgical Mesh Claims News: FDA to Possibly Call for More Testing

The FDA meet for 2 days earlier in September to determine if vaginal mesh or surgical mesh may need to be reclassified as a "High Risk" surgical medical device. Surgical or transvaginal mesh devices were cleared under the 510(K) process. The 510(K) process allows products to be approved without extensive studies if the product "substantially equivalent" to other products in the market. Surgical Mesh Claims and side effects have been on the FDA radar since October of 2008 when the FDA sent letters to surgeons and medical professionals advising them on the potential side effects of Surgical Mesh Devices

Reportedly from these most recent Surgical Mesh FDA meetings, a number of surgical mesh manufactures agreed that future versions of surgical mesh should face more stringent testing. Also it was discussed that labeling changes should be made to Trans Vaginal Mesh in order to warn of side effects a patient can suffer. To date of this page update, no ruling has been made in terms of changing surgical mesh to a “high risk” category. However, it appears that more testing may be required into order for new versions of surgical mesh to be allowed on the market. During the FDA trans-vaginal mesh meetings, Piet Hinoul a director at Johnson and Joshson (makers of mesh devices) noted transvaginal mesh is not “ the optimal solution for everyone.” Mr. Hinoul also remarked that surgical mesh could be an solution for a few.

The FDA has received numerous complaints regarding surgical mesh over the years in addition to surgical mesh claims being made via surgical mesh lawsuits in the courts. The FDA previously reported from 2005 - 2008 a thousand reports were filed from almost 10 different surgical mesh manufacturers that complications were associated with Surgical Mesh devices. It is noted that the FDA received over 1,500 reports of complications from surgical mesh devices from 2008 to 2010.

If the FDA does classify Surgical Mesh Devices as” high risks”, the marketers and the manufacturers of these products will have to conduct studies on post market medical trends, and provide that information to the FDA to review.

Check back to our Surgical Mesh Claims Homepage or Surgical Mesh Claims News page for more information on vaginal mesh litigation, class action or MDL developments.