Mesh Sling Complications: Feasibility of Accessing Data From Patients Involved in Mesh Litigation

Blaivas J1, Chughtai B2, Li E3, Dayan L4, Kalkan S5, Prishtina L6, Mathew J6

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 697
Urogynaecology 6 - Mesh / Sling Complications
Scientific Podium Short Oral Session 33
Friday 6th September 2019
16:07 - 16:15
Hall G3
Quality of Life (QoL) Retrospective Study Incontinence Female Surgery
1.Icahn School of Medicine at Mount Sinai, New York, NY, 2.Weill Cornell Medical College, New York, NY, 3.SUNY Downstate College of Medicine, Brooklyn, NY, 4.Hackensack Meridian School of Medicine at Seton Hall University, Nutley, NJ, 5.Bezmialem Vakif University, Istanbul, 6.Institute for Prostate and Bladder Research, New York, NY
Presenter
E

Eric S W Li

Links

Abstract

Hypothesis / aims of study
Considerable controversy exists about the safety of synthetic mesh slings (SMUS). A rich, but previously un-tapped cohort is potentially available from the nearly 130,000 patients who have filed lawsuits against the mesh manufacturers. The aim of this feasibility study is to avail ourselves of this cohort for clinical research into the prevalence, severity, clinical course, diagnosis and treatment outcomes of SMUS complications. We are hopeful that this data can ultimately be used to generate data that is not generally available in the literature because, in many instances, the entire medical record of individual patients is available for review, even when patients change provider or move to different regions or locations. To be clear, this research has nothing, whatsoever, to do with adjudicating whether or not the mesh itself causes any complications nor does it weigh in on the merits of the legal cases.
Study design, materials and methods
This is a retrospective observational study of a deidentified database extracted from the medical records of mesh litigation cases filed with a single law firm and reviewed by a single expert witness who had access to all available medical records and 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 “tie breaker,” was convened and devised criteria defining definite, possible and non-mesh complications. Plaintiffs with insufficient records were excluded. Definite complications include mesh erosion, urethral obstruction (BOO) requiring surgery or catheterization, adjacent organ injury from trocars (e.g. bladder perforation), mesh-related infection (excluding UTIs), and recurrent stress urinary incontinence after partial or complete sling excision. Possible complications include pelvic pain, dyspareunia, refractory overactive bladder (OAB), urinary fistula, recurrent urinary tract infections, and pelvic organ prolapse (POP). 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
Sixty-three cases were reviewed and 2 were excluded because of incomplete medical records. Mean age at surgery was 49 years (SD 12, range 28 – 76). Definite complications were documented in 37/61 (61%) of cases and 16/61 (26%) had possible complications. Eight out of 61 cases (13%) had non-mesh related complications. Mean follow-up was 3.8 years with a median of 3.2 years (range 0 – 11.5 years). The mean interval between SMUS implantation to the first definite and possible complication was 2.3 (SD 2.4) and 1.4 (SD 1.9) years, respectively (range 0 – 10 years). Two patients presented with their first complication five years or more after their original mesh implant surgery. Table 1 depicts other results.
Interpretation of results
Approximately 61% of patients suffered definite complications and another 26% had possible complications of the mesh surgery. No matter what the final breakdown, though, we believe this data validates our hypothesis that the enormous cohort of mesh legal cases represents, by far, the largest case series of mesh complications ever reported and is worthy of study. Of particular importance is the fact that over half the patients had chronic pelvic pain that, for most, has had a major negative impact on their lifestyle.
Concluding message
Patients who have filed lawsuits against mesh manufacturers provide a rich database for clinical research because complete medical records are usually available. In this feasibility study appropriate medical records were available in 97% of patients of whom 61% had definite and 26% had possible mesh complications. We hope to recruit more expert witnesses and legal firms to participate in this study to enrich our current understanding of the safety of synthetic mesh slings.
Figure 1
Disclosures
<span class="text-strong">Funding</span> Institute for Bladder and Prostate Research <span class="text-strong">Clinical Trial</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics not Req'd</span> This was a retrospective observational study based on medical chart review in which all patient data was de-identified. <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes