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Failure to warn of risks of polypropylene mesh implant

October/November 2021

Raeann Bayless, 48, suffered from vaginal prolapse and stress urinary incontinence. When her condition worsened, she underwent a robotic-assisted hysterectomy and pelvic floor reconstructive surgery using Coloplast Corp.’s Restorelle Y polypropylene mesh and Boston Scientific Corp.’s Advantage Fit Transvaginal Mid-urethral Sling System. Bayless experienced problems after the surgery, including pelvic discomfort, vaginal odor, and bowel movement changes. Approximately a year after the surgery, she developed vaginal bleeding and pain during intercourse. An examination revealed exposed mesh. Bayless was later diagnosed as having infections and vaginal erosion resulting from mesh. She will likely require future surgery, and it is unlikely that her chronic inflammation and pain will resolve even with medical or surgical intervention.

Bayless sued Coloplast Corp. and Boston Scientific, alleging negligence, strict liability, breach of warranty, and fraud. The plaintiff argued that her injuries resulted from the designs of the Advantage Fit and Restorelle Y mesh and the material used to manufacture them. Bayless claimed that the defendants had failed to fully disclose the risks and complications of the implants.

The jury awarded $500,000, finding Coloplast 100% at fault.

Citation: Bayless v. Boston Sci. Corp., 6:20-cv-00831-RBD-GJK (M.D. Fla. June 22, 2021).

Plaintiff counsel: Jeffrey Haberman, Fort Lauderdale, Fla.