Transvaginal mesh maker accused of using counterfeit materials

2012 TVM serious complications Transvaginal mesh maker accused of using counterfeit materialsBoston Scientific is adamant that it didn’t purchase counterfeit plastic materials from a Chinese supplier to produce its transvaginal mesh device for the treatment of pelvic organ prolapse. But a 60 Minutes investigation has uncovered evidence that suggests otherwise.

CBS’s 60 Minutes reported that emails show the company knowingly bought the counterfeit parts from a Chinese supplier and even repackaged the material to hide that it was an imitation product.

Boston Scientific and other manufacturers of transvaginal mesh devices have been caught up in massive litigation for years alleging the devices are defective and have caused women serious injuries from the mesh migrating, eroding into tissue and puncturing organs. The device cannot always be removed completely, and injuries have left women in constant pain and prone to infection.

Boston Scientific used Marlex in its vaginal mesh products, a brand of polypropylene sold by a Texas subsidiary of Chevron Phillips. In 2005, Chevron Phillips stopped selling Marlex to Boston Scientific over concerns that the material was not suitable for permanent implantation in humans. In 2010, another Marlex supplier refused to sell polypropylene for medical devices.

Boston Scientific was caught in a tight spot. Its vaginal mesh was approved by the Food and Drug Administration (FDA) with Marlex. “Boston Scientific’s global sourcing division decided to use a middleman with no direct link to Boston Scientific so the plastic makers wouldn’t know the true buyer,” the 60 Minutes report stated. “But that plan failed.”

According to the 60 Minutes report, Boston Scientific was sued for smuggling a counterfeit version of Marlex from China, but the federal judge turned the case over to the FDA. The company that supplied the product was China-based Emai Plastic Raw Materials, and a company rep told the medical device company that it had “tons” of Marlex imported from Chevron Phillips in Texas. Boston Scientific’s rep in China asked his supervisors if he needed to ask Emai if the materials were supposed to be used in implants. The supervisor reportedly said, “Please don’t tell them where we will use it, it could scare them away.”

When Boston Scientific checked the lot numbers of the products it purchased from Emai and confirmed with Chevron Phillips, it turned out that the products and packaging were fake.

Boston Scientific denied the allegations brought by the 60 Minutes report, saying that it only offered a one-sided commentary from experts involved in lawsuits against the company. “It is important to keep in mind that polypropylene-based (plastic) devices have been a mainstay in many medical procedures for more than 50 years, including hernia and tendon repair, sutures, and wound closure,” the company said.

Medical Device and Diagnostic Industry
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