FDA: Proposal to Call Pelvic Mesh High-Risk, Require Testing

by Searcy Denney Scarola Barnhart & Shipley

A major move toward public safety may be one step closer with the U.S. Food and Drug Administration announcing this week that it will put a proposal out for public comment that would reclassify pelvic organ prolapse (POP) mesh from moderate to high risk. If approved, that move would require mesh manufacturers to test their product for human safety before it’s sold. Amazingly, the FDA does not require the permanent implants to be tested for assurances of safety and efficacy before they are marketed.

At least 75,000 mesh implants annually were implanted in women in recent years to shore up sagging organs, a fairly common condition as women age or have children. Unfortunately, the gap in safety review has resulted in at least 70,000 lawsuits in the U.S. and many more outside the country since the manufacturers export their medical devices.

Call up the FDA and tell them that pelvic mesh is a dangerous medical device!

Susan Laine of the FDA’s press office tells us that the agency has received 20,000 adverse event reports for POP mesh from January 2011 to December 2013 and that is what prompted the proposal.

The public will have 90 days to comment online, on the phone and in writing to the FDA beginning May 1. The comments will be part of the Federal Register.

What’s notable is that the FDA has never acknowledged that mesh for stress urinary incontinence (SUI) is causing as many injuries to women as pelvic mesh and this proposal does not include mesh for SUI.

Mesh injuries include migration and erosion into organs and tissues, infection, nerve damage, mesh shrinkage and chronic pain. Often removal surgery is necessary but pelvic mesh is intended to be a permanent implant and removals are difficult if not impossible. Often the most experienced surgeons cannot remove the mesh anchors which are stapled into a pelvic floor. Then there is the polypropylene itself which is a plastic and may be behind the systemic issues such as arthritis, Lupus, allergies, rashes and fibromyalgia which show up in so many women after their pelvic mesh implants.

Back in July 2011, the FDA did a turnabout and said that pelvic mesh compilations are “not rare” and that mesh may offer no benefits over a traditional suture repair. Three years earlier the agency had called complications “rare” but then complications soared five-fold leading to the 2011 warning.

Among the six major manufacturers, Johnson & Johnson is facing about 30,000 product liability lawsuits so this proposal offers progress to those who feel mesh should have always been tested before it was sold and implanted in the unsuspecting.

The proposed reclassification follows other FDA actions and statements related to transvaginal POP repair materials going back 6 years:

  • October 2008 — Released a Public Health Notification about serious complications associated with transvaginal placement of surgical mesh for POP and SUI
  • July 2011 — Released an updated  safety communication about serious complications associated with transvaginal POP repair  with surgical mesh
  • July 2011 — Released a review of urogynecologic surgical mesh adverse events and scientific literature, identifying serious safety  and effectiveness concerns
  • September 2011 — FDA’s Obstetrics and Gynecology Devices Panel recommended reclassification of surgical mesh for transvaginal POP repair from class II to class III and require premarket approval
  • January 2012 — FDA ordered manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns about surgical mesh used for transvaginal POP repair


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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