FDA Safety Alert Reveals Growing Number of Surgical Complications Involving Transvaginal Mesh

 Posted on December 26, 2014 in Defective Medical Devices

Transvaginal mesh is a medical device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is a permanent implant designed to strengthen a weakened vaginal wall in the instance of POP or to reinforce the urethra to treat SUI. In 2011, the FDA issued a follow-up of its health notification from three years previous, which alerted people to the complications linked to transvaginal mesh when treating either of these medical conditions.

The updated safety alert identified additional concerns and growing numbers of reported difficulties involving surgical mesh devices. From the time between the initial communication in 2008 through to the end of 2010, the FDA recognized that complications were continuing at a high rate and were not considered a rare occurrence. More than 1,500 additional cases involving transvaginal mesh for POP repairs were documented and nearly 1,400 reports were linked to repairs for urinary continence.

According to The Harvard Medical School, over 1 in every 10 women will undergo prolapse surgery by the time they turn 80 years of age. Prolapse may be discovered during regular pelvic exams or carry symptoms including:

• pelvic pressure or pain;
• difficulty in starting to urinate;
• constipation.

The FDA concluded that using transvaginal mesh for POP repair leads to risks not shown during traditional non-mesh POP repair surgery such as:

• pain, bleeding, and/or infection;
• mesh erosion through the vagina (protrusion);
• painful sexual intercourse (dyspareunia);
• urinary difficulties.

Numerous patients have also reported vaginal scarring, neuro-muscular problems, and recurrent prolapse when using transvagainal mesh for a procedure, which may require extra surgical treatment, intervention, or hospitalization. In instances where transvaginal mesh is used, the risks may outweigh the benefits.

The FDA states that in most cases, mesh is not needed to treat POP successfully. Manufacturers are accountable for the products they sell and hold liability when they cause people injuries and discomfort, especially when a product has been reported to do more harm than good.

If you or someone you know has suffered complications treating SUI or POP with transvaginal mesh in Illinois, contact an Arlington Heights defective medical device attorney today. You may be eligible for compensation. We want to help protect your rights.