Devices

Boston Scientific Charged with Racketeering

A class action suit filed in West Virginia federal court alleges that Boston Scientific participated in an international conspiracy to sell defective vaginal surgical mesh made from counterfeit materials smuggled from China. The suit contains charges under the Racketeering and Corrupt Organizations Act (RICO) on behalf of women who have suffered severe discomfort, bleeding, infections, painful intercourse, urinary problems, and other complications from the mesh implants.

The suit claims that after Boston Scientific lost its U.S. supplier of the Marlex synthetic resin approved by FDA for use in producing the mesh, it bought unverified, substandard material from a known counterfeiter in China. Attorneys who filed the suit are asking for a temporary restraining order to prohibit the company from selling any medical devices containing the harmful material.

The lawsuit is the first to accuse Boston Scientific of engaging in an international conspiracy to import tainted plastic resin for the mesh. It also names a Chinese company that allegedly sold the stock and participated in the conspiracy, along with two other companies that were involved in the manufacturing process.

“Boston Scientific knowingly sold a product that put women’s health and their lives at risk,” says attorney Amber Mostyn, who filed the suit. “It conspired with questionable suppliers in China to get material that it couldn’t get in the U.S. and went to great lengths to hide it.”

Although tests showed significant differences between the Chinese resin and the genuine Marlex, the company still ordered production, despite FDA requirements that device manufacturers reapply for clearance when any material is changed in a permanent implant device, Mostyn says. The suit says that rather that reapply for 510(k) clearance, Boston Scientific “deceptively promoted, marketed, packaged, labeled, sold, and distributed this mesh as being manufactured with authentic Marlex and approved by FDA.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome