Public Citizen, a national consumer advocacy group, is urging the Food and Drug Administration to issue a recall for a surgical product designed to help women with a common condition called pelvic organ prolapse. The FDA issued a warning about the product in July, and Public Citizen urges stronger action because the mesh device exposes patients to serious health risks and “the potential for permanent life-altering harm.” On average, around 300,000 women have surgery to correct pelvic organ prolapse, which happens when the muscles holding the bladder, bowel and uterus in place are weakened or stretched and these organs drop into the vagina.
According to Public Citizen, in 2010, around 75,000 surgical procedures to correct this condition used the mesh device, which has resulted in some women experiencing infections, severe discomfort, urinary problems and perforations of the bowel, bladder and blood vessels. Some patients have experienced incontinence and recurrences of the prolapse, resulting in additional surgery to remove the mesh that had eroded the vaginal wall. Dr. L. Lewis Wall of Washington University in St. Louis and Dr. Daniel Elliott of the Mayo Clinic have joined Public Citizen’s petition for a recall of the mesh device.
“The end result [of using the mesh] is oftentimes physically and psychologically devastating for the unsuspecting patient,” Elliott wrote in a letter to the FDA.
Dr. Michael Carome of Public Citizen said the mesh treatment “needlessly exposes patients to a wide array of serious risks…Even the FDA seriously questions the safety and effectiveness of these mesh products.”
The FDA is notoriously slow in removing dangerous and/or defective medical devices from the market. Although the FDA has issued more than 30 recalls of medical devices since the first of the year, that is only a fraction of the potentially dangerous products that are brought to the agency’s attention each year for review and recall. If you are a prolapse patient who has had a mesh device implanted and you are experiencing problems, consult your physician as quickly as practical. If a mesh device has adversely affected your health and quality of life and you want to learn more about your rights and Florida product liability laws, call 888-425-2004 or 407-425-2000 to schedule a free consultation with Orlando personal injury lawyer James O. Cunningham. He has a proven record of success helping patients receive the compensation they deserve through settlements and court awards. Call today to get an experienced Orlando personal injury attorney on your side.
James O. Cunningham
Since 1977, personal injury lawyer James Cunningham has provided effective legal advocacy to people who are injured through the negligent actions of another person or entity throughout the Central Florida area. He fights to obtain recoveries for his clients’ physical and emotional pain and suffering and pursues his clients’ personal injury cases with a commitment to excellence and impeccable preparation.
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