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(USGovernment-News.Com, May 25, 2014 ) New York, NY -- The FDA is proposing that the surgical mesh be classified as “high-risk” rather than “moderate-risk” rating it has today. This proposal comes after years of reports from women suffering from infection, pain, and bleeding after receiving the plastic implants. If this proposal is adopted, manufacturers of the mesh inserts would have to submit human studies that specify that their products are effective and safe to the FDA before they could be sold. The FDA has known for three years that women using plastic mesh have greater complications after surgery than women who receive stitches after surgery.
According to data collected by the FDA, in about 10 percent of cases, the Transvaginal mesh can tear through the vaginal wall into surrounding tissues and organs within 12 months after surgery. Most women who have this erosion must undergo additional surgeries to remove the mesh. Leading manufacturer Johnson & Johnson has received over 22,000 personal injury lawsuits over complications and injuries caused by transvaginal mesh.
The transvaginal plastic mesh has been in use since the late 1990s. The mesh was designed to strengthen the pelvic wall after pelvic organ prolapse. Pelvic prolapse is common in women who have had children and in older women. In most cases, the mesh is inserted into the vagina to strengthen the pelvic wall and prevent prolapse. According to the FDA, the plastic mesh was a “high-tech” solution to traditional stitches during surgery, but no studies have shown that using the mesh improves the safety outcome of the surgery.
The FDA first approved the vaginal mesh products because they were similar to mesh used to treat hernias, which has few complications. All plastic mesh devices had a risk assessment of “moderate-risk,” which is subject to less testing than high-risk products. The FDA is allowing comments on their proposal for 90 days before voting starts.
In the U.S. District Court, Southern District of West Virginia, over 50,000 personal injury suits concerning transvaginal mesh products have been filed. These suits include:
In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325)
In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326)
In Re: Coloplast Corp. Pelvic Support System Products Liability Litigation (MDL No. 2387)
In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation – (MDL No. 2327)
In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2440)
In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2187)
The new FDA proposal does not include other mesh products used for medical procedures to treat hernias, incontinence, and other procedures that are not related to women’s health, the Associated Press reports.
[ bigstory.ap.org/article/fda-wants-stricter-safety-rules-pelvic-mesh May 2014 ]
Andres Alonso And David Krangle, Attorneys With Almost 40 Years Of Collective Legal Experience, Have Focused Their Law Practice On The Handling Of Significant Personal Injury Cases, Defective Drug And Medical Device Litigation, Construction Site Accidents,Nursing Home Abuse, Medical Negligence, Qui Tam/Whistleblower Actions And Consumer Fraud Cases. A Nationwide Law Firm Representing Injured Victims Throughout The U.S., Alonso Krangle Llp Is Headquartered In Long Island, New York, With Offices In New York City, And New Jersey. To Discuss Filing A Transvaginal mesh Lawsuit, Please Contact Alonso Krangle Llp At 1-800-403-6191 Or Visit Our Website, Http://Www.Fightforvictims.Com
For More Information About Alonso Krangle Llp Or To Join The Fight And Be A Part Of Our Team, Please Contact Us At 1-800-403-6191 Or Visit Our Website, http://www.fightforvictims.com
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