FDA Considering High Risk Classification for Surgical Mesh

The makers of surgical mesh may soon have to submit additional safety data to regulators in order to keep their products on the market. New reports have shown that the use of transvaginal surgical mesh has failed to yield better results than non-mesh procedures. The surgical mesh can also pose a higher risk to patients. Patient advocates are demanding a recall of the devices, which are currently classified as moderate risk devices by the FDA.

Transvaginal surgical mesh was previously approved by way the FDA’s 510(k) process, which isused to evaluate products on a comparison basis, stacking them up against similar products already on the market. However, 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.

Bookmark and Share

Comments are closed.