More than 100,000 female patients are now suing Transvaginal mesh, a surgically implanted hammock-like device, has been implanted in over 2 million women in the United States. After years of controversy over how safe or effective the product is, the implant is now the subject of one of the largest multi-district litigations the country has ever seen. More than 100,000 female patients are now suing over complications that they suffered because of these plastic implants.
Boston Scientific is one of the companies that manufacture transvaginal mesh, and they are now facing 48,000 lawsuits from women who claim that the device causes severe pain and injuries.
At Parker Waichman LLP, we understand the severe side effects of transvaginal mesh implants and feel that the corporations that have put their profits ahead of people’s health should be responsible for compensating the women who have suffered as a result of corporate negligence.
What is transvaginal mesh meant to treat?
Transvaginal mesh is implanted in women to treat common post-pregnancy complications such as pelvic organ prolapse (POP) and urinary incontinence. Research indicates that treating POP with transvaginal mesh can cause a variety of symptoms and complications including pain, bleeding, infections, painful intercourse, mesh erosion, organ perforation, and urinary problems. The complications associated with treating urinary incontinence with transvaginal mesh include infections, mesh erosion, and pain.
Patients who were implanted with transvaginal mesh have described the pain as feeling like there was “a cheese grater inside” them and complained of frequent infections and other issues after having the mesh implanted.
Boston Scientific Products Used Questionably Sourced Plastic
Dr. Michael Margolis has surgically removed mesh implants from about 350 patients. Margolis has also served as a witness for plaintiffs suing Boston Scientific. The slings Margolis has removed had often changed in their structure a great deal from when they were implanted. He stated that the devices have “shrunk by 50% in width.”
The devices are meant to be implanted and remain in place for the patient’s entire life without altering its size or shape, but what Margolis was seeing was devices that had contracted, been folded, that were encased in scar tissue, and that were far smaller than they were when they were surgically implanted. The changes took place within just two years.
The plastic that Boston Scientific used in their mesh is called polypropylene. The Food and Drug Administration approved the use of this type of plastic, specifically when it was manufactured by Chevron Phillips and sold under the brand name “Marlex,” for use in mesh implants.
Boston Scientific was then faced with a problem in 2004 when Chevron Phillips stated that the plastic they were selling to Boston Scientific should not be used in products that are intended to be permanently implanted in patients.
Another witness for the plaintiffs, Duane Priddy, who is an expert in plastics, has said that polypropylene, which is frequently used in packaging materials, should never be used in implantable medical devices because it is “oxidatively unstable.” Essentially, this means that the plastic breaks down when exposed to oxygen. While the plastic used contained additives to slow the deterioration, the additives dissipate, and eventually, the plastic begins to deteriorate.
By 2005, Chevron Phillips firmly refused to sell any more plastic to Boston Scientific. Because Chevron Phillips’ product was specifically approved by the FDA, Boston Scientific began searching for stockpiles of the product, Marlex, to purchase from other companies. After another supplier also refused to sell the product to Boston Scientific, the company attempted to buy the product through an anonymous intermediary, but that attempt failed as well.
Finally, Boston Scientific came across a broker called Emai, which was located in China. The broker claimed to have Marlex that they had imported from Texas. Boston Scientific did not reveal to the seller that they intended to use the product in implant devices. Once the product came, it was determined that the lot numbers were fake and that the labels contained numerous errors. To get the bags through customs, Boston Scientific had to cover the bags with other packaging.
Boston Scientific’s own tests comparing the product purchased in China to the original product indicated that 9 out of 11 parameters tested indicated the products were not the same. The company declared the material to be the same material anyway and ultimately used it in implant devices.
Experts Say Materials Inferior, FDA Disagrees
After looking at the Chinese product, Duane Priddy stated that not only was it inferior, but that he estimated that if it were used in the human body, it could only be expected to last for a matter of months- a far cry from the 20 to 40 or more years the product is meant to last.
Chris DeArmitt, a plastics engineer, stated that the product would be fine for making a “disposable cup,” but that nothing indicates that it has been tested for use in humans. Margolis said what Boston Scientific did was tantamount to human experimentation.
The FDA, however, decided the product did not create new concerns about patient safety.
Free Vaginal Mesh Lawsuit Case Review
At Parker Waichman LLP, we have been fighting for greater government oversight in the area of medical devices. We have served as advocates for people who have suffered greatly because of defective and dangerous medical devices. Parker Waichman LLP is nationally recognized in the field of defective medical device litigation. Our attorneys are proud to aggressively represent our clients who have suffered severe injuries from medical devices.
If you have suffered harm due to a vaginal mesh implant, contact us today at 1-800-YOURLAWYER (1-800-968-7529) for your free consultation with one of our experienced vaginal mesh lawsuit attorneys.
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