Regulatory Warnings and Use of Surgical Mesh in Pelvic Organ Prolapse

In 2002, the US Food and Drug Administration (FDA) approved mesh for the surgical treatment of pelvic organ prolapse and in 2008 released a public health notification of risks associated with this use of surgical mesh.¹ In 2011, the FDA released an updated communication questioning the effectiveness of vaginally placed mesh as compared with the nonmesh repair of pelvic organ prolapse and reported 1503 mesh-related events (5-fold increase) in the Manufacturer and User Device Experience database from January 1, 2008, through December 31, 2010.² We sought to determine the extent of use of vaginal mesh in pelvic organ prolapse after the most recent FDA warning and patterns of discontinuation of the use of vaginal mesh in New York State.

We used data from the New York Statewide Planning and Research Cooperative System, which contains records of all surgical procedures done in the state. Patients undergoing surgical procedures for pelvic organ prolapse with or without the use of mesh from January 1, 2011, to December 31, 2013, were identified through previously described methods.³ Patients with previous repairs of prolapse were excluded. The average annual hospital volume of prolapse repair surgery was categorized into tertiles. The teaching status of a particular hospital was obtained by linking to the American Hospital Association database. We evaluated trends in the use of vaginally placed mesh both overall and stratified by hospital volume and teaching status. We calculated estimates and 95% CIs and obtained 95% CIs for zero-frequency cells with the method introduced by Hanley and Lippman-Hand.⁴

This study was approved by the Weill Cornell Medical College Institutional Review Board.

The annual number of repair procedures for pelvic organ prolapse decreased from 6960 in 2011 to 5757 in 2013. The use of mesh after the 2011 FDA warning declined from 30% (95% CI, 29%-31%) to 23% (95% CI, 22%-24%) in 2013, with the decrease being more pronounced in low-volume than in high-volume centers (from 25% [95% CI, 23%-27%] to 15% [95% CI, 13%-16%] vs from 37% [95% CI, 35%-39%] to 34% [95% CI, 32%-36%]; P < .01) (Figure). The decrease was also more dramatic in nonteaching than in teaching facilities (from 29% [95% CI, 27%-30%] to 20% [95% CI, 18%-21%] vs from 32% [95% CI, 31%-34%] to 27% [95% CI, 25%-29.0%]; P < .01).

Eighty-eight physicians performed at least 5 prolapse repair procedures annually during the 3-year period covered in the study and used mesh in the year 2011. In 2012, a total of 14 physicians, consisting of hospitals and outpatient surgical centers stopped using mesh, followed by another 8 in 2013 (Table). In terms of pelvic organ prolapse procedures performed, most of these institutions were low-volume facilities.

We found that after the 2011 FDA warning, mesh use decreased from 30% in 2011 to 23% in 2013. In a prior analysis covering the period after the first FDA warning in 2008, we found that mesh use increased from 21% in 2008 to 30% in 2011.³ The FDA message in 2008 urged physicians to obtain specialized training for each technique in which mesh was used and to be aware of risks associated with the use of mesh. The 2011 FDA communication included stronger language about complications of the use of mesh, describing them as “not rare” on the basis of an internal systematic review. The FDA also stated that pelvic organ prolapse could be repaired without mesh and provided recommendations about the transvaginal repair of such prolapse for both physicians and patients. Although other explanations are possible, we believe that the stronger language in the 2011 FDA warning is at least partly related to the decline in mesh use and has implications for future risk-communications policy, suggesting that stronger regulatory warnings can influence physicians’ use of potentially unsafe medical devices.

We also found that most of the decline in the use of mesh in the post-2011 warning period occurred with low- to medium-volume centers of procedures involving its use and in nonacademic centers. The smaller decrease in academic and high-volume centers of procedures involving the use of mesh is interesting and might represent these centers’ treatment of disease of higher-grade severity or a higher comfort level with the use of mesh (based on experience) in the absence of strong recommendations from professional societies.⁵ The higher rate of decline in the use of mesh by low-volume and nonacademic providers may be related to a lower tolerance for litigation related to sizable awards and growing numbers of lawsuits in outpatient settings.⁶

Our study is unique in including an entire state’s data and a recent period in the use of mesh. However, some variability in the use of mesh among states is possible and should be considered when generalizing to the US population. Another limitation of our study is its use of billing codes that are not specific to vaginally placed mesh. Although codes related to abdominally placed mesh were excluded, some misclassification may still have occurred.

Corresponding Author: Art Sedrakyan, MD, PhD, Department of Healthcare Policy and Research, Weill Medical College of Cornell University, 402 E 67th St, Ste LA223, New York, NY 10065 (ars2013@med.cornell.edu).

Published Online: December 21, 2015. doi:10.1001/jamainternmed.2015.6595.

Author Contributions: Dr Sedrakyan had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: All authors.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Sedrakyan, Mao.

Obtained funding: Sedrakyan.

Administrative, technical, or material support: Sedrakyan.

Study supervision: Sedrakyan.

Conflict of Interest Disclosures: None reported.

Funding/Support: The study was funded in part by grant 1U01FD004494-01 from the US National Institutes of Health and US Food and Drug Administration (Dr Sedrakyan).

Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Additional Information: Dr Chughta is a senior investigator and Dr Mao is an analyst within the Weill Medical College of Cornell University Patient-Centered Comparative Effectiveness Program and the US Food and Drug Administration’s Medical Device Epidemiology Network’s Science and Infrastructure Centre, of which Dr Sedrakyan is director.