Counterfeit Materials from China Used in Transvaginal Mesh Linked to Miscarriages
Posted on behalf of Harbin & Burnett on Jan 21, 2016 in Defective Products
Another manufacturer of transvaginal mesh devices is facing a lawsuit. Boston Scientific, based in West Virginia, is being charged with allegations that their vaginal mesh devices contained toxic resin from counterfeit materials produced in China.
If the charges are confirmed, Boston Scientific could be facing criminal charges and higher fines than other companies involved in transvaginal mesh lawsuits.
Transvaginal Mesh Troubles
Vaginal mesh has been in use since 2002 to treat pelvic organ prolapse, a condition where internal organs protrude into the walls of the vagina. It is a common condition after childbirth and can cause pain and discomfort, but is generally not life-threatening.
Over the course of several years, tens of thousands of women came forward with complaints of complications, including bleeding, ulcers, tissue erosion, perforation of organs, infections and even miscarriages due to the mesh.
As a result, a series of lawsuits have been filed against separate medical device manufactures, including C.R. Bard, Johnson & Johnson - Ethicon, American Medical Systems, Coloplast and Boston Scientific.
One of the key issues being addressed with transvaginal mesh deals with the Food and Drug Administration's classification system.
Vaginal mesh had been designated a "class II" device, meaning it did not have to submit data from clinical trials prior to being sold on the market, because it was "substantially similar" to other types of surgical mesh commonly used in hernia operations.
After much criticism, the FDA has recently reclassified vaginal mesh as a class III product and new devices will require more thorough testing.
Boston Scientific RICO Charges
The case against Boston Scientific goes much further than product liability lawsuits like those against other vaginal mesh producers. The firm who filed the lawsuit is charging them with federal racketeering, alleging the company smuggled in counterfeit material from China to make the implantable devices.
The Racketeering and Corrupt Organizations Act (RICO) lawsuit was filed on Jan. 14 on behalf of women who have suffered due the faulty mesh. The suit explains that Boston Scientific started illegally smuggling counterfeit Chinese resin into the country, after losing its U.S. supplier.
The firm is not just seeking compensation for damages, but to shut the company down and prevent them from continuing to sell the dangerous surgical products.
If you or a loved one has suffered due to a defective medical device, the experienced attorneys at Harbin & Burnett can help you get the justice you deserve. Call today for a free consultation.