FDA Considers Reclassifying Transvaginal Mesh Implants As High Risk

 Posted on July 29, 2014 in Defective Medical Devices

Transvaginal mesh implants have often come under fire in recent years for faulty manufacturing and patient complications. Urogynecologic surgical mesh implants are used to provide support for organs and tissues that are weakened or damaged. They are made of synthetic materials that are often absorbable, or a combination of both absorbable and non-absorbent materials, according to the U.S. Food and Drug Administration (FDA). They are used specifically to treat pelvic organ prolapse and stress urinary incontinence. There are three types of urogynecologic implants: transabdominal mesh, a mesh sling, and a transvaginal mesh implant. While each has its own risk, transvaginal mesh implants are arguably the most risky.

In 2008, the FDA issued a public health notification to healthcare practitioners about the dangers of transvaginal mesh implants. At that time, the FDA had received more than 1,000 reports from nine different surgical mesh manufacturers of serious complications during surgery and recovery. Healthcare providers were, at that time, urged by the FDA to inform patients of the risk (including serious side effects such as pain during sexual intercourse and the narrowing of the vaginal wall), and provide patients with a written copy of the manufacturer's label.

Yet many healthcare providers failed to properly warn patients of the side effects of transvaginal mesh implantation, and now, more than half a decade later, several lawsuits have been filed against the transvaginal mesh manufacturers.

These high-profile cases could be one reason that the FDA is re-evaluating its stance on transvaginal mesh implants. In April, the FDA announced the reclassification of their transvaginal mesh products to a Class III (high-risk) device category. They are currently categorized as a Class II, or moderate risk, device.

If you or someone you know has experienced serious negative side effects from a transvaginal mesh implant operation in the Chicago area, you may be eligible for compensation. Contact an experienced Arlington Heights defective medical device attorney at Newland & Newland, LLP for a free initial consultation today.