Urogynecology Expert Witness

Overview

About Urogynecology Expert Witnesses

A urogynecology expert answers whether a pelvic floor operation was the right one for this patient, whether it was done properly, and whether a complication was recognized and managed. Mesh dominates the field's litigation, but the same questions apply to any repair. The expert separates a known risk from a departure in care. On the device side, the expert separates a problem with the product from a problem with how it was used. This page covers female pelvic floor surgery. Urologic care in general and general gynecology have their own pages.

Mesh: Keep the Procedures Apart

The first mistake to avoid is treating all mesh as one thing. The FDA says there are three main procedures performed with surgical mesh for pelvic floor disorders: transvaginal mesh to treat pelvic organ prolapse, transabdominal mesh to treat prolapse, and a mesh sling to treat stress urinary incontinence ¹. The agency says each has unique risks and benefits and warns against confusing them ¹. An opinion must name the procedure, the product, and the date.

The regulatory history for transvaginal prolapse mesh is short and pointed:

• January 2016. The FDA issued a final order requiring the filing of a premarket approval application for surgical mesh for transvaginal prolapse repair ².
• April 16, 2019. After reviewing the applications, the FDA ordered all manufacturers of surgical mesh for transvaginal prolapse repair to stop selling and distributing their products immediately ¹. It determined the manufacturers did not demonstrate reasonable assurance of safety and effectiveness ¹.
• Today. The FDA says there are currently no FDA-approved surgical mesh products for transvaginal repair of prolapse marketed in the United States ¹.

Different rules apply to slings. FDA's page on stress urinary incontinence describes studies, ordered under its postmarket authority, comparing mini-slings with traditional mid-urethral slings, and reports that mini-slings showed comparable effectiveness and similar types and rates of adverse events through 36 months ³. The adverse events assessed included mesh erosion, organ perforation, mesh exposure, severe pain and re-surgery ³. So a sling claim stands on a different record than a prolapse mesh claim.

Patients Who Already Have Mesh

The FDA says people who received transvaginal prolapse mesh should continue routine follow-up and that there is no need to take additional action if they are satisfied and have no symptoms ¹. They should tell their provider of complications or symptoms, including persistent vaginal bleeding ¹. That framing matters to causation and to a removal decision. Removal is itself major surgery, and it may not relieve all symptoms. An expert compares what the patient reported, what examination and imaging found, and what the operation achieved.

Standard of Care and Consent

For surgical conduct, the expert reviews whether conservative options were considered, whether the operation fit the anatomy and symptoms, and how the patient was counseled. The evaluation may include examination findings and any urodynamic testing. The operative note is read for port or trocar placement, bladder inspection, and any concurrent procedures. Bladder, ureter and bowel injuries are known risks, so the question is often whether the injury was recognized at surgery or soon after. A patient who has urine leakage, fever or severe pain after surgery should prompt a timely search for the cause.

Consent is often central, because what a patient was told depends on the date. Guidance and warnings changed over the years, so the expert should anchor the opinion to what was known at the time of surgery. The treating surgeon's own training on the device can also be relevant.

Device Claims and Preemption

A product claim brings federal questions. Riegel v. Medtronic held that the Medical Device Amendments bar common-law claims challenging the safety or effectiveness of a device marketed in a form that received premarket approval ⁴. Many older mesh products reached the market by a different route, so counsel should identify how the particular device was cleared, since that may decide whether the defense applies.

Who Is Qualified, and Who Does What

Look for a physician with fellowship training in female pelvic medicine and reconstructive surgery who performs the operation at issue and manages its complications. Experience with mesh removal is especially useful. A urologist may fit depending on the procedure. The NIDDK says treatment depends on the type of urinary incontinence a person has, so the diagnosis itself can be a point of dispute ⁵. A biomedical engineer or materials scientist addresses the mesh itself. A pathologist addresses explanted tissue, and a pain specialist or life care planner addresses ongoing need.

Qualifications

Qualifications to Look For

• ✓Fellowship training in female pelvic medicine and reconstructive surgery
• ✓Board certification in obstetrics and gynecology or urology, with subspecialty training
• ✓Active practice in the operation at issue
• ✓Direct experience managing mesh complications and removal
• ✓Knowledge of the FDA record as of the date of surgery
• ✓Ability to read operative notes, urodynamics, and imaging
• ✓Prior deposition and trial testimony in surgical or device cases

FAQ

Frequently Asked Questions