A Pennsylvania appellate court recently upheld a $13.5 million award granted to the plaintiff of a transvaginal mesh lawsuit.

Plaintiff Sharon C. won the multi-million dollar award in February 2016 after a jury determined that the Ethicon transvaginal mesh was not safe. The state appellate court’s decision will uphold this award after the court determined that there was sufficient evidence to back the jury award.

“The instructions for use in use at the time of [Sharon’s] initial surgery in 2005 listed transitory local irritation and transitory foreign body response among its potential adverse reactions,” the decision said. “Ethicon’s IFU provided no warning about the risks of foreign body reaction, fibrotic bridging, mesh shrinkage, vaginal scarring, vaginal perforation, nerve damage, chronic pain, dyspareunia or complications requiring mesh removal.”

Sharon allegedly suffered from urinary incontinence and uterine fibroids, leading her to have serious back pain. To alleviate this pain, Sharon reportedly underwent a procedure in 2005 during which she was implanted with Ethicon transvaginal mesh.

Transvaginal mesh products are often used to repair weakened or damaged tissue in the pelvic area. These products are frequently used in the surgical repair of organ prolapse, stress urinary incontinence, and other conditions.

However, the Ethicon mesh was allegedly defective, Sharon claimed. The mesh reportedly left Sharon with chronic pain and interfered with her sex life. Additionally, she allegedly required multiple corrective surgeries to fix the issue. These complications prompted Sharon to file a transvaginal mesh lawsuit against Ethicon.

Sharon claimed that the mesh company knew that their products carried serious risks but failed to warn doctors and patients of the potential for injury. Ethicon allegedly downplayed the risk of their transvaginal mesh and misinformed doctors about the adverse event outcomes from the product.

The jury in Sharon’s mesh lawsuit agreed with her and, in February 2016, awarded her $13.5 million in compensation. Ethicon attempted to challenge the award by arguing that Pennsylvania state courts did not have jurisdiction over the lawsuit, but these arguments were ultimately rejected by the state’s appellate court and Sharon’s multi-million dollar award was upheld. The company may continue to try to appeal the award.

In April 2019, the U.S. Food and Drug Administration (FDA) ordered several transvaginal mesh manufacturers to pull their products from the market in the United States. According to the FDA, Boston Scientific and Coloplast have not demonstrated that their products are safe and effective.

“Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions,” said Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health.

“The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”

The Transvaginal Mesh Lawsuit is Case Nos. 1129 EDA 2016 and 1294 EDA 2016 in the Pennsylvania Superior Court.