Manufacturers of surgical mesh, like Johnson & Johnson, may soon be required to submit additional safety data to the U.S. Food and Drug Administration in order to keep their products on the market. Reports released this week indicate that the use of transvaginal surgical mesh has failed to produce better outcomes than non-mesh procedures and can also pose a greater risk to patients. Patient advocates are demanding a recall of the devices, which currently carry the FDA’s “moderate risk” classification.
Transvaginal surgical mesh was approved via the FDA’s 510(k) process, which is used to evaluate products on a comparison basis, stacking them up against similar products already on the market. The U.S. Institute of Medicine recently outlined flaws with the surgical mesh and asked that the FDA reconsider its approval and require manufacturers to prove the efficacy and safety of new products on their own merit, rather than via the 510(k) comparative process.
From January 2008 to December 2010, the FDA received approximately 1,500 reports of complications associated with surgical mesh when used for pelvic organ prolapse procedures. A consumer advocacy group known as, Public Citizen, has asked that the mesh be recalled and reclassified, a change which could take the FDA several years to complete. In the meantime, the agency has advised patients to educate themselves on the risks of using surgical mesh, including erosion, pain and urinary incontinence.
