Following Food and Drug Administration communications about the safety of transvaginal prolapse, more than 73,000 patients with complications from treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have filed product liability claims. This research analyzes the transvaginal mesh claims filed in the United States to identify key characteristics that may inform clinical decision-making.
We evaluated a 1% random sample from the Bloomberg Law Database: 2000 to 2014 and associated legal documents. Outcomes and measures used included annual rate of claim, mesh type, time interval between surgery and claim, defendants, and surgeon training.
The search returned 76,865 results, and 2979 were excluded, leaving 73,915 claims. Of 739 claims (1%), 63.3% involved slings for SUI, 13.3% mesh for POP, and 165 (23.2%) involved both. The mesh named most often in claims was retropubic slings at 30.3% and transobturator slings at 27.1%. The number of cases filed increased significantly from 730 in 2011 to 11,798 in 2012, which then almost tripled in 2013 to 34,017. The interval from surgery to claim filing ranged from 4.8 to 5.3 years. Only 12% of implanting surgeons were or became board certified in Female Pelvic Medicine and Reconstructive Surgery. Only 4 cases named providers as codefendants.
Most legal claims involved slings for SUI and began after the 2011 Food and Drug Administration communication about mesh for POP. The rise in lawsuits does not reflect the acceptably low complication rates for slings for SUI reported in the literature.
From the *Department of Surgery, Division of Urology, †Urology Residency Training Program, Cedars-Sinai Medical Center, Beverly Hills, CA; ‡Hugh & Hazel Darling Law Library, University of California Los Angeles School of Law, Los Angeles, CA; §Office of Alexander Souders; and ∥Urological Research, Cedars-Sinai Medical Center, Beverly Hills, CA.
Reprints: Jennifer T. Anger, MD MPH, Urological Research, Cedars-Sinai Medical Center, 99 N La Cienega Blvd, Suite 307, Beverly Hills, CA 90211; or UCLA Urology, 200 Medical Plaza Driveway #140, Los Angeles, CA 90024. E-mail: email@example.com.
Colby P. Souders, Lauren N. Wood, Alexander R. Souders, Lynn McClelland, and Vicki Steiner have no disclosures and report no conflict of interest. Karyn S. Eilber declares that she is an investigator for Astellas and Boston Scientific and a consultant for Allergan. Jennifer T. Anger declares that she is an investigator and expert witness for Boston Scientific Corporation. Dr. Anger also declares that she is an investigator for Astellas.