Chicago Accident and Injury Lawyer Blog

The U.S. Food and Drug Administration (FDA) has issued updated safety warnings to health care professionals and patients regarding the placement of surgical mesh through the vagina (also known as transvaginal mesh) to treat pelvic organ prolapse (POP). Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.

According to the FDA, who reviewed Medical Device Reports (adverse event reports) submitted to the FDA, evaluated published literature on the topic, and considered suggestions made at the September 2011 Obstetrics-Gynecology Devices Panel meeting, it is now considering the recommendation that transvaginal mesh be reclassified from a Class II device to a Class III device. As our Chicago Mass Tort Lawyer Blog has discussed in the past, there are various levels of federal oversight for the many medical devices available on the market depending on the risks that the devices present. Devices are categorized into three classes with Class I devices (things like elastic bandages) subject to the lowest level of oversight, Class II devices subject to additional "special controls," and Class III devices subject to the highest form of federal oversight.

Since the transvaginal mesh is currently classified as a Class II device, which allows the devices to be cleared for market pursuant to the FDA's 510(k) approval process, manufacturers were not required to conduct safety testing prior to making it available on the market. Many oppose this approval process since it allows companies to avoid conducting safety studies that could otherwise protect patients.

The FDA will now require transvaginal mesh manufacturers to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices. These studies "will enable the agency to better understand the safety and effectiveness profiles of these devices." The FDA promises to provide additional information as it becomes available.

Close to 75,000 women a year have had transvaginal mesh devices inserted to treat POP. Since 2008, the FDA has received over a thousand reports of complications due to the devices, including injuries and death.

The products liability attorneys at the Law Offices of Jeffrey J. Kroll feel strongly that patients should not receive medical treatment or have medical devices used on them that have never undergone significant safety testing. Sadly, many women are now suffering because they received unsafe treatment. In light of this new warning, the Chicago mass tort lawyers at the Law Offices of Jeffrey J. Kroll hope that doctors and healthcare providers stop using this risky product and that the FDA reclassifies the product, requiring clinical trials.