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FDA Raises Concerns over Johnson & Johnson’s Transvaginal Surgical Mesh

Approximately five weeks ago, our Chicago medical malpractice attorneys reported on the dangers and problems associated with Johnson & Johnson’s transvaginal surgical mesh implants. To date, more than 270 lawsuits have been filed against Johsnon & Johnson, the New Jersey-based manufacturer and distributer of medical equipment and products. Other manufacturers and distributers of surgical mesh around the United States are also facing litigation.

According to recent reports by the FDA, approximately 75,000 women each year have surgical mesh devices inserted vaginally to treat pelvic or genital complications. However, the FDA’s latest updated analysis shows that problems and adverse effects are not rare in cases involving the use of surgical mesh in vaginal surgical procedures.
According to the FDA, surgical mesh is a medical device that is generally used to repair weakened or damaged tissue, and can be used to mend a weakened vaginal wall, or support the urethra or bladder neck during a procedure for urinary incontinence. The most common complications reported in the analysis were mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, as well as emotional problems. Many of these difficulties require additional or supplemental surgical and medical treatment, and may incur costly medical bills.

The FDA initially warned of dangers associated with the product on July 13 of this year, and last month reclassified the devices, increasing their rating from ‘moderate risk’ to ‘high risk.’ Last week, a panel of FDA advisers participated in a two-day hearing to determine whether transvaginal surgical mesh can still be used as a safe and effective medical treatment, or whether the manufacturers must submit more safety data to keep their products on their market. Deputy Director of the FDA Center for Devices and Radiological Health has stated that “the clinical effectiveness of surgical mesh for transvaginal repair of POP has not been demonstrated.” If the harms are greater than the risks, the product ought to be taken off the market.

Although the FDA advisory panel hasn’t yet made any formal decisions as to predictions of whether or not the surgical mesh will stay on the market, they will soon likely conduct further clinical studies to determine that outcome. Illinois products liability cases – especially those relating to medical devices – allow consumers to be compensated for injuries when a defective product fails and causes injury. When manufacturers and distributers put a product on the market, they are liable for the product, and are expected to have ensured its safety by testing the product before releasing it to the general public.

In addition, Illinois product liability lawsuits send a message to negligent companies, and act as a warning to other manufacturers, who will hopefully be more careful as a result of facing the threat of litigation.

Our Chicago personal injury attorneys have handled numerous cases of product liability, and understand what it takes to gain a successful outcome. If you or a loved one has suffered due to a faulty medical device, an attorney will be able to help you understand your rights under the law.