Transvaginal Mesh Lawsuit

The FDA issued its first Public Health Notification warning healthcare providers of serious complications associated with transvaginal placement of surgical mesh for POP and SUI repair. The notification catalogued 1,000+ adverse event reports in the MAUDE database covering five years (2000–2007), identifying mesh erosion, infection, pain, urinary problems, and bowel complications as the primary injury categories. Manufacturers were asked to review their labeling and ensure surgeons received adequate training — a voluntary measure that produced no measurable industry response.

The FDA updated its safety communication, now finding that serious complications associated with surgical mesh for transvaginal repair of POP were 'not rare' — a significant escalation from the 2008 language. The FDA had received an additional 2,874 adverse event reports in the three years since 2008, more than doubling the total. The FDA issued 522 post-market surveillance study orders to nine mesh manufacturers, requiring them to conduct prospective clinical studies on their devices. The communication specifically called out the 510(k) clearance pathway as insufficient to establish safety for this device class and stated that it was 'not clear' that transvaginal POP repair with mesh was more effective than traditional non-mesh repair.

The FDA reclassified surgical mesh used for transvaginal repair of pelvic organ prolapse from Class II (moderate risk, 510(k) pathway) to Class III (high risk, requiring Premarket Approval). This was a landmark determination: Class III designation requires manufacturers to submit clinical trial data demonstrating safety and efficacy before marketing — the same standard applied to implantable cardiac devices. The FDA simultaneously ordered manufacturers to submit PMA applications by a specified deadline or cease marketing their POP mesh products. This reclassification effectively acknowledged that the 510(k) pathway had been an error for this device category and that a decade of injuries had occurred because of inadequate premarket review.

The FDA ordered the two remaining manufacturers still selling surgical mesh for transvaginal POP repair — Boston Scientific and Coloplast — to immediately stop selling and distributing their products. The FDA determined that the manufacturers had not provided a reasonable assurance that the probable benefits of these devices outweigh the probable risks. This constituted a mandatory market withdrawal — effectively a recall ordered by the FDA rather than voluntary. The FDA found that the PMA studies submitted failed to demonstrate safety and efficacy and that continued marketing could not be justified. Surgical mesh for SUI (mid-urethral slings) was not included in the withdrawal order and remains on the market under heightened scrutiny.

Johnson & Johnson's Ethicon subsidiary entered a consent decree with the U.S. Department of Justice and FDA resolving allegations related to the marketing and sale of transvaginal mesh products. The consent decree formalized Ethicon's exit from the POP mesh market, required compliance monitoring, and imposed operational restrictions. The decree accompanied Ethicon's $775M+ settlement of civil MDL claims and came after internal J&J documents — obtained in discovery — revealed that Ethicon executives knew of mesh erosion risks as early as the late 1990s but continued aggressive marketing to surgeons without adequate disclosure of complication rates.