In July 2011, the FDA reported that complications associated with transvaginal mesh surgery were not rare, and included erosion, infections, bleeding, and pain. Further, the agency stated it was not clear that transvaginal mesh repair for pelvic organ prolapse (POP), a condition in which a woman’s pelvic muscles become too stretched or weakened to properly support pelvic organs, was more effective than traditional surgery without mesh.
In January 2012, the FDA ordered 33 manufacturers to conduct additional post-marketing studies on their products to further analyze the potential risks.
In response, Boston Scientific, one of the major manufacturers of transvaginal mesh, has teamed up with the Pelvic Floor Disorders Network (PFDN) to study the effectiveness of treating POP with vaginal mesh. According to a recent press release, the company has contributed $1 million to the study, which has been named the SUPeR clinical trial.
Transvaginal Mesh Lawsuits Consolidated 2012
On February 7, 2012, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated federal lawsuits involving claims about vaginal mesh into one court in the Southern District of West Virginia for pre-trial purposes. Multi-district litigations have been established against mesh manufactures Johnson & Johnson (and subsidiary Ethicon), American Medical Systems, C.R. Bard, Boston Scientific Corp., Coloplast, and Cook.
Women who have filed lawsuits against these manufacturers typically claim that they failed to provide adequate warnings about their products, were negligent in the designing of their products, and failed to perform proper safety studies to confirm their safety and effectiveness.
Details of New Study on Mesh Repair for POP
For the new study funded by Boston Scientific, researchers will enroll about 180 women who are considering surgery for POP and do not plan to have more children. Some of the women will receive surgical repair with the Boston Scientific “Uphold Lite” transvaginal mesh, while others will receive traditional surgery without mesh.
After the surgery, scientists will evaluate patients every six months, collecting data on the success of the surgery, patient safety, body image, quality of life, and cost effectiveness. It is hoped that the data from the study, which is expected to be completed in 2017, will provide more evidence as to the safety and effectiveness of each type of surgery.
“That evidence will help inform clinicians as they make decisions in an effort to provide the best patient care possible,” said Charles Nager, M.D., director of the Urogynecology and Reconstructive Pelvic Surgery Division at UC San Diego School of Medicine.
In the meantime, mesh continues to cause problems for thousands of women, and yet continues to be implanted in woman.
Transvaginal Mesh Lawsuits
Women have filed lawsuits against Boston Scientific, regarding their mesh products that have caused them pain, infection, scarring, erosion, bleeding, and other complications.
Boston Scientific alone faces nearly 6,000 lawsuits in federal and state courts.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.
One Comment
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After the surgery, scientists will evaluate patients every six months, collecting data on the success of the surgery, patient safety, body image, quality of life, and cost effectiveness.
FOR THOSE RECEIVING THE MESH IMPLANT - I HOPE THE STUDIES WILL ALSO LOOK AT WHEN THE MESH STARTS BREAKING DOWN INSIDE THE BODY.
I HOPE THEY WILL ALSO MEASURING FOR LEVELS OF PARTICULATE DEBRIS AND INFLAMMATION.
FOUR YEARS IN TYPICALLY NOT LONG ENOUGH TO DETERMINE LONG-TERM SAFETY OF IMPLANTED DEVICES.
ALSO WHAT KIND OF CHEMICALS AND GASES ARE THESE DEVICES RELEASING AS THEY BREAK DOWN???
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