Boston Scientific faces 48k lawsuits over pelvic mesh implants: 5 things to know

Boston Scientific is involved in tens of thousands of lawsuits filed by women who experienced health complications related to the devicemaker's gynecological mesh implants, according to a "60 Minutes" report aired May 13.

Here are five things to know.

1. Of the more than 100,000 lawsuits women nationwide have filed against devicemakers over the mesh implants, about 48,000 suits involve Boston Scientific.

"It felt like a cheese grater inside of me," Gwyn Madsen, who received Boston Scientific's mesh implant in 2012, told "60 Minutes." "It felt like the material was pulling on the muscles, and I'd get shooting pains … you almost felt like there was something inside of you that was like sandpaper back and forth, every time you'd walk."

2. The company's mesh implants, used to treat stress incontinence, are made out of a type of plastic called polypropylene. In 2014, Boston Scientific's initial polypropylene supplier warned the devicemaker the plastic should not be used for "permanent implantation in the human body." A year later, the company cut off Boston Scientific's polypropylene supply.

3. To avoid seeking FDA approval for the device with a new material, Boston Scientific turned to a Chinese company with a large supply of polypropylene. The "60 Minutes" report cited an email exchange in which one Boston Scientific employee asked, "Do we need to ask [the Chinese company] if this material is supposed to be used in medical implantable?" In response, Boston Scientific's director of materials management said, "Please don't tell them where we will use it. It could scare them away," according to the report.

4. The FDA conducted an "extensive investigation" into the polypropylene after learning Boston Scientific changed suppliers, according to an official statement emailed to Becker's Hospital Review.

"The FDA conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications," the statement said. "As a result, the FDA concluded that the new resin does not raise new safety or effectiveness concerns."

5. Boston Scientific called the "60 Minutes" report "irresponsible and misleading," in an official statement on the company's website.

"The claims made by '60 Minutes,' which suggested that our transvaginal mesh products contain counterfeited and smuggled materials, are completely false," a company spokesperson told Becker's Hospital Review. "All of our products meet rigorous internal safety standards, as well as the standards of the FDA and other regulatory bodies."

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