Chicago Accident and Injury Lawyer Blog

The Chicago products liability attorneys at the Law Offices of Jeffrey J. Kroll recently read the news that a type of Johnson & Johnson surgical mesh is the target of nearly 500 lawsuits across the country. The San Francisco Chronicle reported that close to "75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapsed," also known as POP. Since 2008, the FDA has received over a thousand reports of complications due to the vaginal mesh implants, including injuries and death.

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.

The surgical mesh at issue has been classified as a Class II device, which allows the devices to be cleared for market pursuant to the FDA's 510(k) approval process as long as they are "substantially equivalent" to existing products. Many oppose this approval process since it allows companies to avoid conducting safety studies that could otherwise protect consumers.

A panel of the U.S. Food and Drug Administration (FDA) Obstetrics & Gynecology Devices Advisory Committee has concluded that more clinical studies and more regulations are needed in this area. The Chicago products liability attorneys at the Law Offices of Jeffrey J. Kroll hope that surgeons stop using this risky product and that the FDA recalls the product.