title: Medicolegal issues surrounding devices and mesh for surgical treatment of prolapse and incontinence.
abstract: Legal issues related to vaginal mesh devices for prolapse and incontinence include abnormal injury and inadequate informed consent. Although vaginal mesh devices are currently cleared through the 510(k) process, new developments at the US Food and Drug Administration requiring additional postmarket studies (522 studies) for transvaginal mesh for prolapse and mini-suburethral synthetic slings have been issued to ensure product safety and effectiveness. New initiatives including unique device identification numbers and the Pelvic Floor Disorders Registry have been developed to improve surveillance throughout the total product/device life cycle.
authors.affiliation: Section of Female Pelvic Medicine and Reconstructive Surgery, Department of ObGyn and Urology, MedStar Washington Hospital Center, Georgetown University School of Medicine, Washington, District of Columbia, USA.
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Nosti
authors.forename: Cheryl B
authors.initials: CB
authors.lastname: Iglesia
mesh_terms: D005260:Female; D006176:Gynecology / Q000193:education; D006801:Humans; D007258:Informed Consent; D008318:Malpractice / Q000331:legislation & jurisprudence; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011183:Postoperative Complications; D011358:Product Surveillance, Postmarketing; D019736:Prostheses and Implants / Q000009:adverse effects; D012307:Risk Factors; D013526:Surgical Mesh / Q000009:adverse effects; D014481:United States; D014549:Urinary Incontinence / Q000601:surgery*