Transvaginal Mesh Considered High Risk by Federal Advisory Panel

October 12, 2012 (Press-News.org) Last month, a federal advisory panel met to discuss the dangers of transvaginal mesh - which is often used when repairing pelvic organ prolapsed in women - and conferred about whether additional testing may be required for new transvaginal mesh products before they can be approved for use by the Food and Drug Administration (FDA).

Specifically, the FDA has proposed moving transvaginal mesh products into the highest-risk medical device class, otherwise known as Class III - meaning additional testing would be needed in the future before these products could be approved.

Although a formal vote was not tallied in the recent meeting, the majority of the advisory panel - which consisted of medical experts - supported this reclassification by the FDA. And even though the FDA isn't required to adhere to the panel's recommendations, it often does.

Implications of Transvaginal Mesh Reclassification

Currently, transvaginal mesh products are generally eligible for an FDA review process known as 510(k) - meaning the products can obtain FDA approval without clinical trials as long as the product is "substantially equivalent" to a product already on the market. The idea behind this approval process is that is allows companies to update their current devices without having to complete an arduous approval process with each small change. However, given the recent problems reported with transvaginal mesh devices, the use of the 510(k) approval process with these products has been called into question.

From 2008 to 2010 the FDA received five times as many reports of adverse events with transvaginal mesh used in pelvic organ prolapse repair - a total of 1,503 reports - when compared to the previous three year period.

If the FDA were to reclassify transvaginal mesh products, it would require mesh manufacturers to complete clinical trials, and thus more testing, before submitting their application for FDA approval. While this change would obviously add costs to manufacturers, it would also hopefully make transvaginal mesh products much safer for patients in the future.

Problems Associated with Transvaginal Mesh

Concerns surrounding the use of transvaginal mesh are nothing new. In fact, back in July 2011 the FDA issued a statement warning of the dangers reported by women implanted with transvaginal mesh to repair pelvic organ prolapsed (POP).

According to the FDA's statement, some of the most common side effects associated with transvaginal mesh originated with the mesh protruding out of the vaginal tissue, often causing pain, infection, bleeding and urinary issues.

If you have injured as a result of a transvaginal mesh implantation, it may be advisable to contact an experienced transvaginal mesh attorney. An experienced attorney can review your case and provide helpful guidance based on your circumstances.

Article provided by Babbitt, Johnson, Osborne & Le Clainche, P.A.
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