FDA May Classify Surgical Mesh Devices for Failing Organs as High Risk

Johnson & Johnson, Boston Scientific Corp. (BSX) and other makers of surgical mesh may have to submit added safety data to regulators to keep their products on the market under a Food and Drug Administration staff recommendation.

The transvaginally implanted products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients, according to a report released today. Patient advocates are demanding a recall of the devices, now classified as moderate risk, and the FDA’s outside advisers will examine the issue next week.

The devices were approved through a streamlined process called 510(k) that is used to evaluate products similar to those already cleared and itself is under an agency review. The U.S. Institute of Medicine cited flaws with surgical mesh in July when it urged the FDA to abandon the process and require makers to prove each product is safe and effective on its own merits. The FDA is soliciting comment on the recommendation.

Mesh products “may expose patients to greater risk” than traditional repairs without mesh, FDA staff said in the documents, adding they have “not seen conclusive evidence” of improved clinical outcomes with the devices.

The agency received 1,503 reports of complications associated with the material from January 2008 to December 2010 when used for pelvic organ prolapse, the FDA said in a safety warning July 13. The devices were used in 75,000 transvaginal surgeries last year, according to the FDA.

Patient Advisory

The agency advised patients to be aware of risks including mesh erosion, pain and urinary incontinence, and to have annual check-ups after surgery. The FDA said it has cleared 85 surgical mesh devices to treat pelvic organ prolapse from 1992 and 2010.

Johnson & Johnson (JNJ), based in New Brunswick, New Jersey, and Boston Scientific of Natick, Massachusetts, didn’t immediately respond to requests for comment.

Consumer advocacy group Public Citizen, based in Washington, said Aug. 25 that the mesh devices should be recalled and reclassified.

A change in risk classification may take several years to complete and the agency said it could consider a grace period for makers of products on the market to submit data to comply with a more stringent review. The agency may require companies to conduct post market studies that could be designed to support future submissions to comply with the new process.

The devices are used in surgeries to address prolapsed organs and incontinence. About 300,000 women underwent surgical procedures last year to repair prolapsed organs, FDA data show.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Steve Walsh at swalsh@bloomberg.net