Activist Urges Mandatory Recall for Transvaginal Mesh

Barely a week after FDA ordered the reclassification of transvaginal surgical mesh for pelvic organ prolapse (POP) to Class III and the submission of safety-documented PMAs from their manufacturers, an activist claiming to represent thousands of mesh-injured women is urging the agency to recall the devices from the market. Canada-based Nonie Wideman told CDRH director Jeffrey Shuren in a 1/12 email that “[w]e are aghast that you would not include SUI [stress urinary incontinence] in the reclassification effort for the POP mesh products.” Without explanation, FDA’s 1/4 order explicitly excluded meshes indicated for SUI.

In her protest to Shuren, Wideman asserted that SUI meshes “are substantially the same material [as POP mesh] with the same erosion, degradation, migration, nerve damage, and chronic inflammation problems which lead to autoimmune problems. The SUI mesh products cause equally devastating and catastrophic nerve and organ damage.” She told FDA Webview that these problems affect about 30% of women who undergo mesh implantation, whether for POP or SUI, due to allergic responses to the mesh materials and added chemicals and dyes.

Wideman’s direct approach to Shuren follows the recent trend established by Philadelphia cardiothoracic surgeon Hooman Noorchashm in which hundreds of women injured by Essure permanent contraceptive coils and others with power morcellator-caused cancers deluged his FDA email inbox with their complaints. Wideman acknowledged to FDA Webview she is following this person-to-person example, which is unprecedented in FDA history. Shuren has responded to the earlier campaigns impersonally, through an FDA Web site Essure page update.

In her email, Wideman told Shuren “[i]t does not stand to reason that you can reclassify one mesh as high risk and ignore the substantially equivalent smaller product that causes bladder, urethra and vaginal injuries as well as the often permanent nerve damage and autoimmune problems. … I no longer believe Class III designation is enough to protect patients from less than predictable and certainly not inert mesh implant materials. PMA protects manufacturers. It does not protect patients. I now believe the only way to protect patients is to recall all synthetic mesh products and only permit the use of these products in rare circumstances when no other option is available. The FDA has done too little too late. The only way the medical community will realize the devastation mesh has caused, is to recall the meshes.”

Asked why SUI meshes were excluded from the POP mesh reclassification, FDA spokesperson Deborah Kotz told FDA Webview only that “FDA believes that Class II (general and special controls) provides a reasonable assurance of safety and effectiveness for mesh to treat SUI.” She did not respond to a follow-up request for elaboration and said FDA does not comment on letters it receives.

One clue as to why FDA formed this belief might lie in the reclassification order’s history. In response to FDA’s proposal in 2014, the Society of Gynecologic Surgeons wrote that “because of widespread confusion among the lay population which has attended the previous FDA advisories, we ask that the FDA further clarify and highlight that use of type 1 monofilament polypropylene surgical mesh for surgical treatment of stress urinary incontinence (i.e., mid-urethral slings) and abdominal pelvic organ repair (i.e, sacral colpopexy) has become the standard of care, that these therapies are not the subject of the advisory letter, and that these products are not being reclassified. This will help to minimize these potential points of confusion for patients, patient advocacy groups and gynecologic surgeons.”

It appears that FDA has followed this advice. Wideman, who runs a Web site for mesh-injured women at meshproblems.weebly.com that she says has logged over 6,000 hits, told us that many of the surgical society’s leaders have been and still are preceptors for the mesh manufacturers.