A class action lawsuit has been filed in federal court alleging Boston Scientific ran a conspiracy to use counterfeit materials from China to make its transvaginal surgical mesh. The devices have been the target of criticism and thousands of lawsuits from injured patients in recent years.
A West Virginia woman filed the suit, which claims that when the company started running out of the material required to make transvaginal mesh in 2011, it smuggles a counterfeit version of the material out of China. Boston Scientific said in a statement Friday it doesn't believe the case has merit and plans to “vigorously defend” itself against the allegations.
“At Boston Scientific, patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products,” according to the statement.
Boston Scientific, along with other manufacturers of transvaginal mesh, have faced tens of thousands of lawsuits over the products in recent years. The devices treat urinary incontinence and other disorders but have caused severe pain and even death in some patients.
According to the lawyers behind the lawsuit filed this week, the action is the first to accuse Boston Scientific of taking part in an international conspiracy to import tainted plastic resin for the mesh.
“Boston Scientific knowingly sold a product that put women's health and their lives at risk,” attorney Amber Mostyn said in a news release. “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.”
The plaintiff in the lawsuit, Teresa Stevens, had a mesh implant procedure in 2014 and now has pain, bladder infections and other complications, according to her lawyers.
Earlier this month, the U.S. Food and Drug Administration said vaginal mesh will now be classified as a “high-risk” medical device and be subject to more regulatory requirements. The FDA will also require companies making pelvic mesh meant to repair pelvic collapse to submit applications showing the safety and effectiveness of their products. The new requirements do not apply to mesh products used to treat other conditions such as hernias or urinary incontinence.
In April 2015, Boston Scientific agreed to pay $119 million to settle nearly 3,000 cases and claims over its transvaginal surgical mesh products. The company did not admit to wrongdoing. In April 2014, Endo International agreed to pay $830 million to settle 20,000 claims over its vaginal mesh products.