New allegations in a lawsuit against Boston Scientific Corp.’s faulty transvaginal mesh (TVM) products claim that the manufacturer used counterfeit materials smuggled from China to produce the products, putting women at added risk.
Boston Scientific had lost its US supplier of synthetic resin that is used to produce the TVM products during the products’ production phase. The supplier, Chevron Phillips Chemical Co., backed out of the use of its US Food and Drug Association (FDA)-approved material, Marlex, for the production of permanent implantation devices. This decision likely stems from a fear of supplier liability.
Boston Scientific then allegedly turned to EMAI Plastic Raw Materials Inc., a Chinese company with a shady reputation of fraud and evasion from Chinese and American authorities. EMAI allegedly supplied Boston Scientific with untested and unapproved resin materials for use in the surgical mesh product.
Transvaginal Mesh Side Effects
TVM products have seen a continued rise in complaints filed by women adversely affected by the medical device. TVM is used to treat conditions in women such as incontinence and pelvic organ prolapse but has been cited in thousands of lawsuits against a handful of mesh manufacturers to cause:
- Chronic pain,
- Infection, and
- Other side effects stemming from complications such as mesh erosion and pelvic organ perforation.
TVM products are designed for permanent implantation. The FDA had recently reclassified surgical mesh as a High-Risk medical product, prompting manufacturers to appropriately document TVM’s safety and effectiveness in order to sustain their products’ premarket approval. Recent lawsuit victories against TVM manufacturers reflect the likely flood of further cases awaiting their day in trial.
What do the new allegations mean for future trials?
Boston Scientific is being sued under the Racketeer Influenced and Corrupt Organizations Act (RICO) on the account of the manufacturer’s illegitimate tactics in acquiring the counterfeit materials from China. RICO has been used against infamous criminal organizations including the Hell’s Angels motorcycle gang, the Gambino Family mafia, the Key West Police Department, and FIFA.
The Chinese supplier has yet to provide any documentation confirming the legitimacy of their claims that the resins were approved Marlex product. It is currently unknown whether the allegedly counterfeit materials have contributed to the severe side effects alleged in many lawsuits against Boston Scientific’s TVM products or if there are still unknown side effects yet to be revealed or reported, making matters even worse for Boston Scientific’s case. The extent of the faux-Marlex’s damage to the TVM victims will most likely be a major factor for future litigations once explored.
Get the help you need
If you or someone you know has a TVM implant and has been suffering from any complications, now is the best time to act on getting the relief you deserve. Many women affected by TVM have experienced victories in lawsuits against medical device manufacturers, and you can have your day in court with the assistance of an experienced and professional personal injury attorney. Find an attorney today and have your case reviewed.