September 9, 2011     The Food and Drug Administration’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh devices for pelvic organ prolapse repair be reclassified from Class II to Class III devices. Panel members also recommended that FDA issue section-522 post-market surveillance orders to current manufacturers of surgical mesh for pelvic organ prolapse repair and that these studies include at least three years of patient follow-up data.

METZ LAW GROUP OBTAPE WORK IN THE NEWS

New York Times, Women Sue Over Device to Stop Urine Leaks

Cleveland Plain Dealer, Patients Sue Maker of ObTape Vaginal Sling over Complications

What is ObTape?

ObTape is a medical device manufactured by the Mentor Corporation designed to treat female urinary incontinence. It was surgically placed in approximately 50,000 women worldwide between 2003 and 2006.

ObTape is associated with a very high rate of vaginal extrusions (i.e. the tape rubs on the top of the vagina until it penetrates the upper wall of the vagina or causes a major irritation to the vaginal wall) and vaginal infections.

Symptoms of vaginal extrusion associated with ObTape include vaginal pain, vaginal discharge, chronic vaginal infections, pelvic pain and pain during intercourse for both women and men. In other cases, ObTape has migrated through the body, causing pain in the back, hip, and legs.

Multiple surgical operations to remove the ObTape are often required to address these problems. Many women have not been cured even after multiple surgeries.

ObTape was removed from the market in 2006.

If you or a loved one has been affected by ObTape, you may be entitled to monetary compensation.

Statutes of limitations may be an issue in many cases, thereby limiting a person’s right to sue. If you suspect that a doctor installed ObTape in you, it is important to call a lawyer immediately.

ObTape High Levels of Erosion

ObTape causes erosion problems at a much higher rate than competing products because the mesh weave is very tight, restricting tissue ingrowth.

Click here to read about why ObTape has high levels of erosion.

The FDA maintains the MAUDE voluntary database to keep track of related incidents. Click here to see more than 200 reported incidents to the FDA. It is estimated that only 1-10% of actual incidents are reported.

Mentor ObTape did not undergo clinical trials prior to receiving approval from the FDA in 2003. Check here to see where Mentor incorrectly claimed that its product is “substantially equivalent in material, function, performance and design to the urethral support tape products manufactured and marketed by Johnson & Johnson.” The Johnson & Johnson product had a much wider mesh weave, and problems with it were relatively rare.

http://www.fda.gov/cdrh/pdf3/k031767.pdf

Please review the following links for more information on ObTape.

1. Complications Associated with TransObdurator Sling Procedures
2. Mentor’s 2003 FDA Approval

Claiming damages caused by ObTape

Claiming your damages promptly is very important. We are presently assisting women and their husbands make claims for pain, suffering, medical expenses, lost wages, and other costs and damages associated with ObTape.

Many women injured by ObTape are in danger of losing their right to claim damages because of statutes of limitations. Statutes of limitations limit the time that a person can sue after discovering an injury. Many states allow lawsuits only within two years of discovery of an injury.

If you believe that you have an ObTape injury, we recommend that you call us immediately at 206-583-2745, to avoid losing your rights because of the statute of limitations. Even if someone has told you that too much time has passed since you first discovered the injury, please call us because there may still be a way that we can make a claim on your behalf.

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