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Manufacturing company to pay Indiana nearly $6 million for unfairly marketing surgical mesh devices

Indiana Governor
Posted at 12:18 PM, Mar 24, 2021
and last updated 2021-03-24 12:18:09-04

INDIANAPOLIS — Indiana Attorney General Todd Rokita secured nearly $6 million in a multistate agreement with a medical manufacturing company accused of deceptively marketing its transvaginal surgical mesh products for women.

Boston Scientific Corporation agreed to pay a settlement of $188.6 million to a total of 47 states, including Indiana, and the District of Colombia on Tuesday following a nationwide investigation into its marketing practices for surgical mesh devices. Indiana will receive exactly $5,982,218 from the settlement.

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue, according to the U.S. Food and Drug Administration. It is mainly used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), in which it is implanted in the pelvic floor through the vagina. POP and SUI are caused by childbirth, age, or other factors.

The Massachusetts-based company allegedly failed to inform its patients of the "full range" of possibly irreversible complications that are caused by surgical mesh implants.

In 2016, surgical mesh implants were classified as "Class III," meaning high risk, by the FDA. Three years later, the FDA ordered manufacturers of all surgical mesh products to stop selling and distributing their products in the U.S. due to places such as Boston Scientific and "Coloplast" not providing "reasonable assurance" of safety and effectiveness for devices.

According to a release from Rokita, thousands of women have said to have suffered serious complications resulting from the devices.

“Women across the country have suffered serious health complications caused by surgical mesh devices, and I will continue to hold companies accountable that misrepresent or withhold information about the risks associated with the devices,” Attorney General Rokita stated in a release.

In addition to the tens of millions of dollars, Boston Scientific must also reform its practices related to surgical mesh, including its marketing, training, and disclosures regarding clinical studies.