Protegen Bladder Sling Litigation
The ProteGen sling is a medical device made of woven polyester impregnated with bovine (beef) collagen. The FDA approved the ProteGen bladder sling as part of the Vesica Sling Kit in April of 1997. The devices were manufactured by Boston Scientific Corporation, a company that claims to be the largest medical device company in the world dedicated to minimally invasive therapy.
These products were used in the surgical treatment of female stress urinary incontinence. Urinary incontinence is the medical term for the inability to control the flow of urine. Stress urinary incontinence is characterized by an involuntary loss of urine during physical activities such as coughing, laughing or lifting, and is the second most common type of urinary incontinence in older women.
How was the ProteGen bladder sling implanted?
The Vesica Sling Kit contained the ProteGen sling, a suture spacer, and metal bone anchors. The ProteGen sling was inserted through an abdominal incision behind the bladder. Using sutures, the surgeon secured the ends of the sling to metal anchors attached to the pubic bone. This sling acted like a hammock, and provided support to the urethra and bladder.
Why was the ProteGen bladder sling withdrawn from the market?
The ProteGen bladder slings and the Vesica sling kits were withdrawn from the market in January 1999. The withdrawal came after several medical studies reported complications and questioned the safety of these medical devices. Boston Scientific acknowledged in their “Dear Doctor” letter of January 1999 that these products did not perform as expected. On March 24, 1999, the FDA labeled these devices “adulterated and misbranded” and concluded that they did not function as intended.
What problems have been associated with these devices?
Medical studies reveal that these slings cause tissue erosion, dehiscence (splitting of the tissues), infections, and other serious complications requiring surgery for their removal. The metal bone anchors are also associated with a significant incidence of infection. Women implanted with these slings have experienced catastrophic injuries, including the need for major surgery and permanent neurological complications.
The index of suspicion for sling erosion or infection should be high in any patient with persistent vaginal discharge, vaginal bleeding, pelvic or abdominal pain, or fever. Every patient who received one of these devices and is having any problems or symptoms should be evaluated by a physician immediately. Even in the absence of symptoms, recipients of these products are still at risk of developing complications in the future and close medical follow-up is strongly recommended.
How can I protect my legal rights?
The law firm of Alley, Clark & Greiwe is currently accepting new clients and referrals of claims involving the ProteGen bladder sling and Vesica sling kit. If you have or someone you know has received a ProteGen bladder sling, please contact Alley, Clark & Greiwe for a free consultation regarding your rights.