Boston Scientific sued over alleged counterfeit component

Boston Scientific has been drawn further into the vaginal mesh controversy, with a lawsuit claiming the company knowingly used counterfeit material in its products.

Houston-based lawfirm Mostyn Law is alleging that Boston Scientific was part of a conspiracy to source substandard polypropylene resin used in its vaginal mesh products "from a known counterfeiter in China" after losing its US supplier for the material (Phillips Sumika's Marlex).

The medical device group says it rejects and will vigorously defend itself from the allegations, which include that it smuggled material into the US, failed to conduct thorough tests and defrauded regulators.

The lawsuit - filed on behalf of plaintiff Teresa Stevens who claims to have been injured by a vaginal mesh product - further alleges that the company sold faulty mesh implants "that have put thousands of women at risk." Other companies named in the suit include EMAI Plastic Raw Materials of Guangzhou, China, Proxy Biomedical Ltd of Ireland and Luxilon Industries based in Belgium.

Boston Scientific and other mesh manufacturers, including Ethicon, are already facing lawsuits from women who claim to have been injured from use of the products, although these are generally on safety grounds and do not relate to the use of counterfeit material.

Mostyn Law has called on Boston Scientific to make internal documents public, and last Friday said it had carried out independent testing that showed the resin "contains dangerous selenium." It also says Boston Scientific sells $120m-worth of vaginal mesh annually, with the product used in around 55,000 women a year.

Vaginal mesh products have been used for years to treat pelvic organ prolapse (POP) and stress urinary incontinence in women and were recently re-classified by the FDA as a class III medical device - one which  carries a high risk - from class II (moderate risk).

The regulatory action came after a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and the new regulations include a requirement for manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh products.

There are five manufacturers of vaginal mesh products in the US market, according to the FDA, which have been given 30 months to submit a retrospective PMA for their already-marketed products.

"Over the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair," said the FDA in a statement issued on January 4.

"The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues."

Other forms of surgical mesh products have also been counterfeited and introduced into the US supply chain. In 2011, medical device distributor Ram Medical has admitted selling counterfeit and contaminated surgical mesh in the USA that it had purchased from suppliers in the Middle East and India.

The prior year, the FDA warned that counterfeit versions of flat polypropylene meshes sold under the Bard or Davol brand names had also been found in circulation.