Investigation over Boston Scientific Counterfeit transvaginal Mesh

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Boston Scientific Corporation is facing criminal investigation; Federal prosecutors claimed the company usage of bogus Transvaginal  mesh implants. Prosecutors are usually in the process of convening a wonderful panel to look at claimed research this company widely used bogus fine mesh brought in via China sold to thousands of American women. A grand jury in Charleston, West Virginia, has already sent out multiple warrant seeking documents concerning Boston Scientifics’ purchase a form of synthesis polyester resin, utilized in making mesh implant. In early January of this year Allegations of counterfeit raw materials first surfaced. A Houston based firm alleges the Boston Scientific and filed a lawsuit in a West Virginia federal court of allegedly smuggling material from china and using it to manufacture mesh devices. According to the lawsuit the company smuggle unapproved substandard material from a known counterfeiter in China.

Boston Scientific is a worldwide company that produces markets and manufactures a large line of products for heart surgery, digestive disorders, pulmonary disease treatment, vascular surgery, urology, chronic pain and women’s health. Boston Scientific manufacture bladder slings and other transvaginal mesh devices designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  The FDA first approved Boston Scientific vaginal mesh devices in 1996 and in 2002 the company won 510(k) approval from the FDA. FDA issued a safety alert on April 1st stating that the agency was looking into allegations that substandard materials were used in Boston Scientifics’ urogynecologic surgical mesh. The decision by the FDA to reclassify the transvaginal mesh products as “high risk products” is a confirmation of the inherent danger of these products.

There was vaginal mesh class action lawsuit filed against Boston Scientific Corporation of illegally smuggling counterfeit resin made in China to make pelvic mesh. The lawsuit was filed earlier this year in the U.S. District Court for Southern West Virginia. The lawsuits allege that Boston Scientific conspired with subsidiaries in Belgium and Ireland to use the counterfeit resin to make the advantage mesh used in all of its pelvic mesh products. FDA regulators didn’t suggest that woman remove the implants, however, it states that be aware of problems stemming specifically from the unapproved resin and noting “available data do not suggest any decreased benefit associated with the device.” The FDA reports that the material used in vaginal mesh products causes serious complications Includes:

  • Projection of the mesh through the soft tissues;
  • Infections in the area of the mesh
  • Urinary tract problems
  • Perforated bladder, perforated bowel or perforated blood vessels
  • Organ injuries
  • Additional surgeries may be required and sometimes the problem still isn’t corrected; and
  • Pain during intercourse.

As per the FDA warnings this vaginal mesh complications are not rare, and can lead to severe life-threatening events and in some unfortunate cases death. Affected patients have been seriously injured when their implant eroded into their vagina, perforated organs, caused chronic pain, often undergo multiple corrective surgeries in an attempt to remove defective devices and repair the damage caused by the mesh.  However, in many cases, it is impossible remove all of the pieces of a defective sling or mesh system. Last year, Boston Scientific paid $119 million to settle about 3,000 lawsuits stemming from its mesh implants, but it still faces thousands of others.

If you or somebody you know was injured or suffered complications or death from Transvaginal mesh, you should contact for a free case consultation. All cases are pursued on a contingency fee basis there are never any out-of-pocket costs to hire our attorneys unless we win your case. The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs Lawsuits.

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