ObTape

ObTape Causes High Levels of Erosion

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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
  3. Johnson & Johnson announced on December 1, 2008 that it would acquire Mentor Corporation for $1.07 billion. Click here to view article from MarketWatch.
 

How Johnson & Johnson Merger Has Affected ObTape Claims

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Johnson & Johnson completed their acquisition of Mentor Corporation on January 23, 2009.   Mentor Corporation manufactured and sold ObTape from 2003 through 2006.

J&J was famous for their deft handling of the Tylenol tampering scare, and some had hoped that after their acquisition of Mentor Corporation, J & J would “come clean”,  admit that ObTape was defective, and make amends for the harm that ObTape has caused for thousands of women.   Such an action might help maintain J & J’s tremendous brand equity, and help disassociate it from the taint of ObTape.    To date, J & J has not come clean, and their ObTape lawyers continue to deny that ObTape was defective.

 

Source: obtapeinjury.com

 

About Ob Tape

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 ABOUT OBTAPE 

Bladder problems are quite common in women, especially one condition known as female stress urinary incontinence.  There are many causes linked to the development of this condition including stress, but the fact remains that this is basically a bladder control problem that also can include extreme pain and discomfort in any woman who suffers from it.

The Mentor Corporation was one of the leaders in researching and developing a product designed to help women get control over this issue, and in 2003, they received news that their product, the OBTape vaginal sling, had been approved for sale and distribution in the United States.

The product sold very well in the early going, and it’s estimated that up to 35,000 women have used it.  It’s given to the woman surgically, and is implanted near the wall of the urethra to help support nearby muscles and thereby the flow of urine.

 

Consequences of using the OB Tape vaginal sling

Unfortunately, only a few years had passed before the OBTape vaginal sling had to be removed from the market because of its link to serious side effects.  The problem that was discovered with the OBTape vaginal sling was that unlike competing products, it was not woven into a mesh-like substance.  This created an impossibility for the flow of oxygen and other nutrients through the frame and into the woman’s system, thereby leading to the development of these side effects.

The consequences of using the OBTape vaginal sling included internal and on-site bleeding, extreme pain, constant discomfort, the loss of any bladder control they had gained with the use of this product and many other maladies.  Even more troubling was the fact that the only way to correct this problem was to have an additional surgical procedure done to remove it from the woman’s body.

 

Mentor Corporation Legal Claims

Due to the prevalence of these problems arising in women, lawsuits began to pile up against the Mentor Corporation all over the United States.  As of this writing, 22 separate lawsuits have been filed against the company because of this allegedly defective product.  The next item on the legal docket is a hearing to determine if these claims should be combined into one action against the Mentor Corporation, which is a common ‘solution’ sought by a defendant in order to simplify its defense to one case instead of potentially dozens.

 


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