Presentation Authors: Jerry G. Blaivas*, Bilal Chughtai, New York, NY, Eric S.W. Li, Brooklyn, NY, Senad Kalkan, New York, NY, Linda Dayan, Nutley, NJ, Learta Prishtina, Joel Mathew, New York, NY
Introduction: Controversy exists about the safety of synthetic mesh slings (SMUS). The aim of this feasibility study is to avail ourselves of a potential cohort derived from approximately 130,000 patients who filed lawsuits against mesh manufacturers. We aim to evaluate the prevalence, severity, diagnostic and treatment outcomes of SMUS complications. Ultimately, the data may be used to estimate the proportion of litigation cases with proven mesh-related complications and the nature of mesh complications.
Methods: This is a retrospective observational study of a deidentified database extracted from the medical records of mesh litigation cases that have been reviewed by at least one expert witness who had access to all available medical records, including expert witness reports for both the plaintiff and defense. A panel, consisting of two expert witnesses each for the plaintiff and defense and a neutral &[Prime]tiebreaker&[Prime] was convened and devised criteria defining definite, possible and non-mesh complications. Disagreement between experts was resolved by the tiebreaker who had access to the deidentified records. Plaintiffs with insufficient records were excluded. Recorded definite and possible complications are listed in Table 1. The following information was extracted: type of synthetic sling, time interval between implantation and first complication, number and type of complications, number of surgeries to treat complications from implantation surgery and outcome of treatment from each complication at the time of the last record.
Results: 47 cases were reviewed and 2 excluded because of incomplete medical records. Mean age at surgery was 49 (range 28 - 76) years old. The mean interval between SMUS implantation to the first definite and possible complication is 27 (SD 29) and 17 (SD 23) months, respectively (range 0 - 120 months). Table 1. depicts other results.
Conclusions: Patients who have filed lawsuits against mesh manufacturers may provide a rich database for clinical research because complete medical records are usually available. In this feasibility study appropriate medical records were available in 96% of patients of whom 73% had definite and 24% had possible mesh complications. We hope to recruit more expert witnesses and legal firms to participate in this study.
Source of Funding: Institute for Bladder and Prostate Research