No pending FDA action on hernia mesh, despite continued significant complication rates

Last week I wrote about the FDA’s decision to ban surgical mesh for transvaginal repair of pelvic organ prolapse (POP).  The FDA took this action only after tens of thousands of lawsuits were filed to recover for injuries caused by transvaginal mesh, 4 years of heightened FDA surveillance of transvaginal mesh complications, more than 2 years that the FDA gave the manufacturers to produce sufficient evidence that the benefits of transvaginal mesh repair of POP outweigh the risks, and an additional year for the FDA to determine that the manufacturers had not produced the required evidence.  https://www.videntpartners.com/blog/2019/fda-bans-surgical-mesh-transvaginal-repair-pelvic-organ-prolapse

Surgical mesh has also been used for decades for the purpose of strengthening hernia repairs and reducing the recurrence rate.  However, like transvaginal mesh for POP repair, hernia mesh is associated with many complications, including pain, infection, hernia recurrence, adhesion, bowel obstruction, mesh migration and mesh shrinkage, and has been the subject of tens of thousands of lawsuits. 

Between 2005 and 2018, the FDA recalled some hernia mesh products, and certain manufacturers voluntarily recalled some of their hernia mesh products.  The FDA apparently takes the position that these recalls have solved the problem:  “Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market.  Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh.  In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”

For an argument that recalled hernia mesh products can’t possibly account for the continuing substantial complication rate (estimated at between 12% and 30%), see https://herniamesh.legalexaminer.com/health/medical-devices-implants/the-fda-still-has-no-warning-about-hernia-mesh/.  For the opposing view, see https://www.stonybrookmedicine.edu/hernia/resources/faqs-about-mesh-in-hernia-repairs

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