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Ethicon Exec: FDA Mesh Safety Notice Could Have Long-Term Impact

This article was originally published in The Gray Sheet

Executive Summary

A manufacturer of surgical mesh devices for minimally invasive gynecological procedures is worried that a recent FDA safety alert may slow long-term adoption of the products even after better data is available

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Surgical mesh alert

FDA warns physicians and consumers Oct. 20 about complications associated with surgical mesh devices to treat pelvic organ prolapse and stress urinary incontinence. The agency said it received more than 1,000 reports from nine manufacturers of problems with transvaginal placement of the mesh devices, including erosion through vaginal epithelium, infection, pain and urinary problems. Physicians should obtain specialized training in mesh placement techniques and monitor for complications, FDA advises. The agency also warned consumers about problems with surgical mesh for hernia repairs

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