Boston Scientific accused of using counterfeit resin in medical device

Boston Scientific is being accused of using counterfeit resin from China to make vaginal meshes that put women’s health at risk

Mostyn Law, a Houston-based firm, has accused Boston Scientific of running an international conspiracy that sold defective vaginal surgical mesh.

Transvaginal surgical mesh is a polypropylene-based product, used along with surgical stitches, to shore up sagging pelvic organs, such as the bladder, uterus and bowels, and to treat incontinence.

The procedure—now considered a high-risk procedure by the Food and Drug Administration (FDA)—has resulted in more than 70,000 lawsuits, including 15,000 against Boston Scientific according to the law firm.

Mostyn Law, headed by attorneys Amber and Steve Mostyn, sued Boston Scientific and three other companies under the Racketeering and Corrupt Organisations Act (RICO) on behalf of women who had the plastic mesh implants.

The class-action lawsuit says that after losing its US supplier of the synthetic resin to produce the mesh, Boston Scientific bought unverified, substandard material from a known counterfeiter in China.

The suit, which the Mostyn firm filed late Tuesday for a West Virginia woman with mesh-related health problems, asks the US District Court in Charleston to prohibit Boston Scientific immediately from selling any medical devices containing the harmful material.

Amber Mostyn said: "We have asked for the court to shut down sales from this company and to protect women from the pain and suffering that can result from this dangerous product." She said Boston Scientific put profits ahead of health concerns, calling the company's disrespect for women "disgusting and appalling."

Chevron Phillips Chemical stopped selling its polypropylene resin for surgical mesh in 2005. The chemical company said it should not be used in medical devices, "involving permanent implantation in the human body or permanent contact with internal body fluids or tissues," according to Mostyn Law.

Boston Scientific ignored those explicit warnings Mostyn Law said and instead imported counterfeit material from EMAI Plastic Raw Materials in china.

The suit seeks unspecified damages for the thousands of women who received a Boston Scientific transvaginal mesh product after September 2012, as many as 55,000 each year.

The suit comes the same month that the FDA announced tighter regulations for surgical mesh products.