Product Liability

Transvaginal mesh problems lead to questions about device approval

The number of adverse reactions associated with surgical mesh used to repair pelvic floor disorders and other conditions, has skyrocketed in recent years, according to the Food and Drug Administration (FDA). This new data brings into question how the FDA determined the mesh was safe for transvaginal use in the first place.

Surgical mesh is used for a variety of procedures, but the device has been shown to cause problems when used trans-vaginally to repair pelvic organ prolapse, a condition in which age, childbirth or obesity cause pelvic muscles and tissues such as the bladder, the top of the vagina, the rectum or small bowel to drop or become compromised. Recently, the FDA issued a safety communication about the surgical mesh informing doctors and patients that between 2008 and 2010, there more than 1,500 reports of problems associated with the device, five times as many as were reported between 2005 and 2007.

The FDA classifies medical devices from Class I, or low-risk, to Class III, high-risk. Class III devices are devices that support or sustain life and whose failure would be life-threatening. These devices are subject to the most stringent FDA device review, and include products such as pacemakers and defibrillators.

Surgical mesh is listed as a Class II medical device, or moderate-risk product. New Class II devices generally go through an approval process known as 510(k). This system allows an expedited approval for products that are “sufficiently similar” to comparable products that have already been approved by the FDA.

There is much talk in the news in recent weeks about whether the 510(k) process should be revamped. Critics have worried that the accelerated approval process puts medical devices on the market before they have been thoroughly tested, and that can put patients’ health at risk.

Upon the request of the FDA, the Institute of Medicine (IOM), a nonprofit, non-governmental organization, recommended that the process be entirely revamped to protect consumers. The FDA says it is considering the IOM recommendation while also lending an ear to medical device companies, who have an obvious vested interest in keeping the 510(k) process in place.

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Source: FDA