How to Avoid and Deal with Pelvic Mesh Litigation.
Medical malpractice as it relates to transvaginal mesh implantation adds another level of responsibility when deciding on surgical options to repair stress urinary incontinence or pelvic organ prolapse. As mesh is a viable option for repair, the informed consent process must involve a time commitment to discuss thoroughly the knowns and unknowns about mesh, and potentially must cover other aspects related to surgery: FDA classification of mesh, experience, potential off label usage, and conflicts of interest. A therapeutic alliance must be developed between physician and patient to allay possible fears about the intrinsic uncertainty of surgery. Proper risk assessment of the patient and pre-operative judgment as to when and if mesh implantation is appropriate are decisions that must be documented. Resolution of a conflict from a complication can be dealt with formally or informally. Above all, sharp skills, good communication, broad knowledge base of mesh surgeries, complication management, knowledge of guidelines, along with methodical documentation can mitigate or avert mesh-related litigation.
Division of Female Pelvic Health, Arizona State Urological Institute, 4530 E. Ray Rad, Suite 178, Phoenix, AZ, 85044, USA. karlovskym@yahoo.com.|Pelvic Mesh Medical Consulting, PLLC, Scottsdale, AZ, USA. karlovskym@yahoo.com.
Matthew E
ME
Karlovsky
D018795:Device Approval; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D016365:Liability, Legal; D008318:Malpractice / Q000331:legislation & jurisprudence*; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D010817:Physician-Patient Relations; D011183:Postoperative Complications; D018570:Risk Assessment; D053825:Suburethral Slings; D013526:Surgical Mesh; D014481:United States; D014486:United States Food and Drug Administration; D014550:Urinary Incontinence, Stress / Q000601:surgery*
FDA bulletins; Informed consent; Litigation; Malpractice; Mesh complications; Standard of care