Medicolegal Issues

The mesh mess, enmeshed in controversy

Author and Disclosure Information

Beginning in the late 1990s, the US Food and Drug Administration cleared more than 150 devices using surgical mesh for urogynecologic indications. As of April 2019, there are no longer any FDA-approved surgical mesh products for transvaginal repair of pelvic organ prolapse. What happened?



CASE Complications with mesh placement for SUI

A 47-year-old woman (G4 P3013) presents 5 months posthysterectomy with evidence of urinary tract infection (UTI). Escherichia coli is isolated, and she responds to antibiotic therapy.

Her surgical history includes a mini-sling procedure using a needleless device and mesh placement in order to correct progressive worsening of loss of urine when coughing and sneezing. She also reported slight pelvic pain, dysuria, and urgency upon urination at that time. After subsequent development of pelvic organ prolapse (POP), she underwent the vaginal hysterectomy.

Following her UTI treatment, a host of problems occur for the patient, including pelvic pain and dyspareunia. Her male partner reports “feeling something during sex,” especially at the anterior vaginal wall. A plain radiograph of the abdomen identifies a 2 cm x 2 cm stone over the vaginal mesh. In consultation with female pelvic medicine and reconstructive surgery subspecialists, lithotripsy is performed, with the stone fragmented. The patient remains symptomatic, however.

The mesh is noted to be eroding through the vaginal wall. An attempt is made to excise the mesh, initially via transuretheral resection, then through a laparoscopic approach. Due to the mesh being embedded in the tissue, however, an open approach is undertaken. Extensive excision of the mesh and stone fragments is performed. Postoperatively, the patient reports “dry vagina,” with no other genitourinary complaints.

The patient sues. She sues the mesh manufacturer. She also seeks to sue the gynecologist who placed the sling and vaginal mesh (as she says she was not informed of “all the risks” of vaginal mesh placement. She is part of a class action lawsuit, along with thousands of other women.


The device manufacturer settled out of court with the class action suit. (The gynecologist was never formally a defendant because the patient/plaintiff was advised to “drop the physician from the suit.”) The attorneys representing the class action received 40% of the award plus presented costs for the representation. The class as a whole received a little more than 50% of the negotiated award. The patient in this case received $60,000.

Medical background

Stress urinary incontinence (SUI) is a prevalent condition; it affects 35% of women.1 Overall, 80% of women aged 80 or younger will undergo some form of surgery for POP during their lifetime.2 The pathophysiology of SUI includes urethral hypermobility and intrinsic sphincter deficiency.3

Surgical correction for urinary incontinence: A timeline

Use of the gracilis muscle flap to surgically correct urinary incontinence was introduced in 1907. This technique has been replaced by today’s more common Burch procedure, which was first described in 1961. Surgical mesh use dates back to the 1950s, when it was primarily used for abdominal hernia repair. Tension-free tape was introduced in 1995.4-6

Continue to: In the late 1990s the US Food and Drug Administration...


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