Vaginal Mesh Recall

Calls for a Vaginal Mesh Recall are growing. Learning more about existing FDA warnings.

To date, the number of vaginal mesh recalls issued by manufacturers have been limited. Despite multiple safety alerts, the FDA is yet to issue a recall on any vaginal mesh products.

For at least a year, public advocates have been calling for a recall of transvaginal mesh due to erosion issues following procedures to repair stress urinary incontinence and pelvic organ prolapse. Vaginal mesh patients and those who plan to undergo one of these surgeries should learn more about vaginal mesh complications arising from insertion of this material into the body. Additionally, women considering these procedures should monitor the news about a potential transvaginal mesh recall.

Vaginal Mesh Recall Status

The U.S. Food and Drug Administration (“FDA”) issued a health advisory in October 2008, noting the complications of transvaginal mesh. It had already received more than 1,000 notifications of complications from nine manufacturers of the products. Complications were noted as “rare” at that time. Since then, the mesh complications have progressed to a degree that is very concerning.

Due to the over 4,000 adverse event reports regarding mesh products used for prolapse repair or stress urinary incontinence surgery, the FDA released a safety communication. Published on July 13, 2011, this document recommended that patients and doctors consider alternative treatments for these conditions. The FDA called for a meeting of an advisory panel that would determine whether this mesh should be pulled from the market.

The advisory panel met in September 2011 and subsequently announced its support of the proposed requirement issued by the FDA. This would subject new mesh devices to comprehensive safety testing before FDA approval was granted. The FDA is still reviewing scientific data regarding mesh use to repair stress urinary incontinence and plans to release a separate report on this topic.

Major Issues Surrounding Transvaginal Mesh Complications

This mesh has been shown to create several complications including pain, bleeding, dyspareunia (painful sexual intercourse), infection, and urinary tract issues. Some patients have experienced mesh protruding from their soft tissues while others have learned that their organs near the surgical site have been damaged by the material. The most common issue involves erosion of the mesh, which typically occurs between four and 16 months following the procedure depending on whether a vaginal or surgical incision was made.

Patients who develop complications from the presence of this mesh typically must have the material excised through a vaginal incision. This process may require multiple surgeries, after which the prolapse must be corrected. Stress urinary incontinence patients are similarly treated by mesh removal, often followed by re-sewing of vaginal tissues. When erosion is present in only a small area, a topical vaginal cream containing estrogen can be applied following stitching. Some SUI patients received an older synthetic mesh used to make a sling typically placed under the urethra. In those instances, erosion is often treated by removal of the sling or exposed mesh and re-sewing of the area.

With an understanding of mesh complications and the factors that could give rise to a vaginal mesh recall, women who are considering these procedures will be better equipped to make decisions about their healthcare. Those who are scheduled for surgery may want to revisit their options for treatment. A medical professional can recommend an alternative treatment that is safer and legal professionals can provide guidance to prior patients who are experiencing complications.

Victims of Mesh Complications Urged to Seek Medical Attention, Legal Counsel

If you or a woman you care about are a victim of mesh complications, please seek medical attention. Be sure to keep records of your medical appointments, procedures, and expenses, as this information may be important if there is a transvaginal mesh recall, or should you choose to pursue a lawsuit against the manufacturer of the mesh that injured you.

If you would like additional information about the potential for a pelvic mesh recall or the legal recourse you may pursue, we urge you to contact Bernstein Liebhard LLP as soon as possible. Our attorneys will thoroughly evaluate your case, and if you have a valid claim, file an individual lawsuit on your behalf. Simply call 1-888-217-3033 or fill out our online form, and someone from our legal staff will contact you shortly.

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