Plaintiffs who filed a transvaginal mesh lawsuit against Boston Scientific may receive payment as the company settles around 50,000 complaints.

According to the company’s annual report filed with the U.S. Securities and Exchange Commission, Boston Scientific Corp. is very close to resolving 50,000 of the 53,000 lawsuits it faces regarding its pelvic mesh implant systems. 35,000 of their settlements have been finalized.

Boston Scientific reportedly met with counsel for each transvaginal mesh lawsuit plaintiff, but does not admit any wrongdoing by settling the cases against them.

“As of Feb. 5, 2019, we have entered into master settlement agreements in principle or are in the final stages of entering one with certain plaintiffs’ counsel to resolve an aggregate of approximately 50,000 cases and claims,” the company’s filing stated.

The company’s filing did not reveal exactly how much it has pledged to pay in its 50,000 settlements. According to Law360, CFO Dan Brennan stated that Boston Scientific paid over $600 million to a pelvic mesh settlement fund. Brennan also reportedly revealed that 95 percent of claims are “settled or on the final stages of settlement”.

Since 2012, Boston Scientific has been involved in the largest multidistrict litigation in U.S. history. The consolidated action combined three other multidistrict litigations and covered 104,000 claims against Boston Scientific and other mesh manufacturers.

Boston Scientific manufactures pelvic mesh products designed to help treat stress urinary incontinence. Plaintiffs in lawsuits against the company claim that the products are defective in ways that can lead to punctured organs, infections, bleeding, pain during sex, and other urinary problems.

In May 2013, 60 Minutes did a segment on Boston Scientific transvaginal mesh and reported that the company knowingly used toxic plastics in their products, including polypropylene. The company allegedly knew that their materials were dangerous for use in the human body, but chose to continue with their manufacturing plan to protect their profits.

After the U.S. Food and Drug Administration (FDA) released a report about serious adverse events with the mesh products, 60 Minutes claims that “Boston Scientific had even more reason to believe that if it switched plastics the FDA would require years of tests which might fail”. The company allegedly decided to use counterfeit plastic materials from China due to a supply shortage.

Controversy regarding transvaginal mesh products has drawn the attention of regulatory bodies. In November 2018, the FDA made the decision to enact stricter requirements to protect women’s health and ensure access to “safe and effective” medical devices.

“The FDA’s efforts on urogynecologic surgical mesh have focused on identifying  benefit-risk concerns related to some of these devices, and strengthening the FDA’s regulatory oversight to protect patients, while enabling those who need these devices to benefit from them,” the agency states.

“Providing patients with access to the safest possible medical devices on the market to meet their health care needs remains a top FDA priority.”

Signs of Transvaginal Mesh Failure

While a woman who goes through this procedure might expect some side effects in recovery from the surgery, she is unlikely to anticipate that the device could completely fail.

Unfortunately, since device failure has been broadly reportedly by people who underwent this implant procedure, a patient must be aware of the possibility and ready to respond by scheduling a doctor’s appointment right away. The mesh might have to be removed, and it’s important to get medical attention from a professional to figure out next steps as soon as possible.

Post-operative symptoms of problems should be monitored closely by the patient in the days following the procedure. If the woman is not able to urinate properly this is a sign that the sling or mesh was improperly installed by the doctor. Most symptoms should go away after around the six week mark.

There are some signs to be aware of if the mesh begins to erode inside the patient. These include urinary issues, recurrence of vaginal prolapse, vaginal scarring, unexplained infections or infections that keep coming back, and the mesh sticking through the bowel, bladder, or vagina. If a woman has not been able to fully bounce back after the procedure and does not know what to do next, then an appointment with a doctor should be scheduled to determine whether or not the mesh has failed. If the mesh has to be removed, this comes with its own set of risks and the woman might have other complications in trying to recover the second time around.

The Transvaginal Mesh Lawsuit MDL is In re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, Case No. 2:12-md-02326, in the U.S. District Court for the Southern District of West Virginia.