History of the Protegen Sling Medical Device for the Treatment of Feminine Urinary Incontinence

A Vaginal Sling or Pubo vaginal sling uses a strip of material to compress the urethra in an effort to treat woman with stress urinary incontinence. Stress incontinence refers to the leakage of urine from the bladder related to excerise as well as coughing or even sneezing. The condition results from a combination of factors, including a weakness of the pelvic floor muscles and a prolapse of the bladder downwards as well as the weakness of the valve controlling the short tube draining the bladder known as the urethra.

Vesica Medical Inc., a company that produced and marketed a medical device known as the Vesica Bone Anchoring System (Vesica System) was acquired by Boston Scientific Corporation (BSC) of Natick, Massachusetts in 1995. The Vesica System was designed for use in the treatment of feminine urinary stress incontinence. The Vesica System has two pins that are inserted into the left and right pubic bone and connected to suture material that leads to either side of the urethra. The pins and sutures were designed to support a "Bladder Neck Suspension" procedure, a technique that did not involve the use of a "sling" device. In August of 1995, BSC began investigating other uses for the Vesica System, including a sling to support the bladder in combination with the Vesica System. Urologists have used slings for many years to treat feminine urinary incontinence by providing support for the bladder neck and thereby reducing the stress on the bladder that produces incontinence. The slings were usually made with the patients own tissue at the surgical site or from elsewhere in the patient's body.

Boston Scientific Corporation also acquired Meadox Medicals Inc, at about the same time in the mid 90's. Meadox manufactured a polyester fabric coated with bovine collagen that was primarily used in cardiovascular applications, trade name, "Hemashield". Boston Scientific decided to develop a "sling" from the same "Hemachield" material.

Boston Scientific Corporation received approval in November 1996 to market a medical device named the "ProteGen Sling" made with the "Hemashield" fabric, for treatment of feminine urinary incontinence. Boston Scientific obtained FDA approval of the "Hemashield" fabric sling by siting biocompatability of the fabric and claiming it was substantially similar to other fabrics such as Gor-Tex, Trelex and Marlex. However, Boston Scientific failed to perform independent animal testing before submitting the "Protegen Sling" for FDA approval.

Boston Scientific Corporation began manufacturing the "Protegen Sling" and in March of 1997 launched a program to market it to physicians without the clinical data supporting their claim of biocompatability of the fabric coated collagen for urological use.

Within a year complaints about complications began coming in to Boston Scientific Corporation (see dangerous complications >>)

Boston Scientific Corporation came under FDA scrutiny in spring 1998 and the FDA inspected the Spencer, Indiana manufacturing plant. Despite Boston scientific's claim that the product failure was due to the failure of the medical community, the company finally recalled the Protegen product in January of 1999. In March of 1999, the FDA notified Boston Scientific that it agreed with the recall decision and considered all lot numbers of the ProteGen Collagen Impregnated sling and Vesica Sling Kits the ProteGen to be "adulterated and misbranded." However, the letter Boston Scientific Corporation sent to notify its Physician clients maintained that only 1% of the devices could have "adverse events".

Many well respected urologists from around the country have expressed criticism of Boston Scientific Corporation for marketing "ProteGen" devices.

Lawsuits arising out of the implantation of the ProteGen Sling and Vesica System continue to be filed all over the country citing defective design, failure to warn, failure to conduct proper clinical testing, negligent physician training, fraud on the FDA, fraudulent concealment and misrepresentation, breach of warranty and other product related claims. The damages in these cases vary from the need for medical monitoring due to the enhanced risk of failure and injury to confirmed cases of tissue erosion, infection and even permanent neurological damage.