There have been over 100,00 lawsuits filed nationwide against manufacturers of transvaginal mesh devices and nearly half of those lawsuits, more than 48,000, involve the Boston Scientific manufactured mesh. Boston Scientific, a Marlborough based company, is widely recognized as one of the leading gynecological mesh implant device manufacturers in the country.
The use of transvaginal mesh implant devices has been seen as common practice by doctors in order to treat women, mostly after childbirth, for incontinence and pelvic organ prolapse. Unfortunately, the negative side effects that accompany the initial mesh procedures as well the subsequent removal procedures of mesh implants can be even more devastating.
At the center of the claims against Boston Scientific, are that the company knowingly used improper and unstable materials, most notably polypropylene, in production of their implant products. According to a recent report, Boston Scientific was made aware by their original polypropylene supplier that Marlex polypropylene must not be used in any “permanent implantation in the human body.” Even after obtaining this information, Boston Scientific wished to continue use of that polypropylene in their devices.
Therefore, Boston Scientific sought out a new supplier and found one in the Chinese distributor Emai Plastic Raw Materials. Allegedly, Boston Scientific did so without conveying to the new supplier that the polypropylene products would be used for medical implant procedures in fear of scaring off the new Chinese supplier.
According to the recent reports, while quality testing the original material to the materials from the new Chinese supplier it was found that, of the 11 parameters used in that testing, only two were the same and the remaining nine were completely different. Under Boston Scientific’s own quality assurance measures proper documentation of the materials was needed, yet Emai could not produce any authenticated documentation. The Chinese supplier’s packaging was also reportedly fraudulent.
Surgeons and patients have been well documented in explaining the negative side effects from the initial and subsequent procedures, including inflammation and excruciating sharp pains. Also documented, is just how considerably changed the mesh implants that use polypropylene are when they are removed as compared to the original implant.
Michael Margolis, a surgeon that has removed approximately 350 mesh implants stated that the implants he has removed that use polypropylene ultimately are “substantially altered in their architecture. They are shrunk by at 50% in width; they are encased in scar tissue.”
Boston Scientific has denied these reports.
If you or a loved one has experienced negative or unwanted outcomes due to mesh operations or subsequent revision surgery please contact the Naumes Law Group for a free consultation at 844-826-8445 or online at www.naumeslaw.com.