New York ProteGen Vaginal Sling Recall Lawyers

If you are one of the many women who sought a medical solution to the common problem of stress urinary incontinence from a device known as The ProteGen Sling, your health may be at serious risk.

In 1997 the FDA approved a medical device known as The ProteGen Sling as a means of surgical treatment for Stress Urinary Incontinence. Stress Urinary Incontinence is an involuntary loss of urine initiated by physical activities such as coughing, laughing, sneezing or lifting. In older women, it is the second most common type of urinary incontinence.

On the market from April 1997 until January 1999
Recently acquired by Boston Scientific Corporation (BSC), Vesica Medical, Inc. had produced and marketed a medical device known as the Vesica System. It was designed for use in the treatment of feminine urinary stress incontinence. At the time of acquisition, the Vesica System did not necessitate the use of a sling device, instead requiring the insertion of two pins into the left and right side of the pubic bone that connected to suture materials that led to either side of the urethra. The pins and sutures were to act as support to a procedure called the "Bladder Neck Suspension" By "suspending" the bladder neck, stress on the bladder is relieved and incontinence reduced considerably.

In the mid 1990's, BSC began to research other uses for the Vesica System, one which included a sling supporting the bladder in addition to the surgically implanted pins and suture material. Although surgeons have been using slings for many years as a treatment for feminine urinary incontinence, the slings were usually made with the patients own tissue.

Around the same time Boston Scientific Corporation added Meadox Medicals, Inc to their acquisitions. Predominantly used in cardiovascular applications, Meadox manufactured a polyester fabric coated with bovine collagen named "Hermashield".

Although BSC failed to perform independent animal testing before submitting the "ProteGen Sling" to the FDA, in November of 1996, The "ProteGen Sling" made with "Hemashield" fabric received marketing approval. BSC sited biocompatability of the "Hemashield" fabric sling, claiming similarity to other fabrics such as Marlex, Trelex, and well known Gor-Tex. In March 1997 marketing commenced targeting the medical industry without clinical data supporting BSC's claim of biocompatability of the fabric coated collagen used with the "ProteGen Sling".

Complications often mistakenly diagnosed as unrelated to the sling
Serious side effects include:

• Vaginal Bleeding
• Vaginal Tissue Erosion And Infection
• Surgical Incision Splitting Apart
• Surgical Wound Site Never Healing With Implanted Sling
• Permanent Neurological Complications
• Major Surgery

ProteGen Sling and Vesica System recalled in January 1999.
Numerous complaints about complications were presented to BSC within a year. Although all lot numbers of the ProteGen product were considered "adulterated and misbranded", BSC maintained only 1% of the devices could produce adverse effects. Some doctors were not aware of the recall, still implanting the device after January 1999.

Lawsuits continue to be filed
Pertaining to the implantation of the ProteGen Sling and Vesica System throughout the United States. Charges include fraud on the FDA, defective design, failure to conduct proper clinical testing, failure to properly inform and train staff members in the medical community, fraudulent concealment and misrepresentation, along with related product claims including breach of warranty.

Let us fight for you
If you or someone you know has been implanted with the ProteGen Sling or a Vesica System, please contact us immediately so we may evaluate your situation and start down the path of finding a solution.

An attorney client relationship is not established by submitting this initial contact information.

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New York, NY 10170

Telephone: 212-986-7353
Fax: 212-953-4308
E-mail: wrs@wrslaw.com