Mentor ObTape Lawsuits Continue To Be Filed
UPDATED: June 19, 2018
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Mentor OB tape is off the market, but Mentor OBTape lawsuits continue to be filed as more becomes known about the company's unethical practices in getting the product approved by the U.S. Food & Drug Administration (FDA).
Mentor ObTape Injuries Could Have Been Avoided
Various medical experts and Mentor OB Tape injury lawyers claim that Mentor ObTape injuries could have been avoided. The Mentor ObTape Vaginal Sling was a medical device known as a a transobturator vaginal sling. It was supposed to replace muscles in the urethra in order to control urine flow and treat stress urinary incontinence (SUI). However, the device simply didn't work as it blocked the flow of much needed oxygen and nutrients and resulted in Mentor OB Tape side effects such as vaginal pain, vaginal discharge, vaginal infection, vaginal extrusion and urinary tract erosion.
The product came onto the market in 2003, but was taken off the market in March of 2006 due to the high volume of reported complications and complaints. There was - and continues to be - controversy over how the product was approved, whether it should have ever been on the market in the first place and that numerous injuries could have been avoided.
Mentor ObTape went through the FDA's 510(k) approval process, which is far less rigorous than a full PMA (pre-market approval) process because the company claimed that the product was “substantially similar” to products already on the market. However, a study published in June 18, 2009 entitled "Testimony Encouraging a More Rigorous Approval Process for Medical Devicesseemed," to show otherwise. It contained the testimony of Dr. Peter Lury to the House of Representatives explaining that the 510(k) for surgical meshes for pelvic organ prolapse contain little, if any, clinical data.
Dr. Lury said that instead of doing its own research, Mentor basically went off of what previous manufacturers had given to the FDA for approval and that these devices were implanted in thousands of women, relying only on scarce clinical evidence. In fact, there was a unique risk of erosion through the patient's tissue that was estimated to occur in an astonishing 10% to 20% of mesh implant cases. Those numbers would have been detected by even a small clinical trial.
In another published article in The New York Times on May 4, 2009, experts commenting on transvaginal surgical mesh lawsuits pending throughout the country were quoted as saying:
The lawsuits raise new questions about the process by which the FDA reviews medical devices. It approves medical drugs, but it merely clears medical devices with minimal testing. So it is deemed substantially equivalent to devices already in use.
Basically, what that means is that manufacturers tell the FDA that they have a similar product to one that's already on the market, that has already gone through the full PMA process, so their product shouldn't have to go through the same rigors. In other words, you already approved their product, so you should approve ours too. Unfortunately, that's exactly what happened in this situation.
Taking Responsibility for Mentor ObTape Side Effects
Even though many say that the FDA should have done more, isn't the ultimate responsibility on the manufacturer to make sure that their products are safe in order to avoid situation like Mentor ObTape and surgical mesh side effects? Absolutely, according to surgical mesh injury lawyers who represent injured victims.
They say that Mentor should take that extra step as it is ultimately liable. It's their product after all; but unfortunately, that's not what always happens. The article published in the The New York Times discusses how Mentor told the FDA that its ObTape was similar to a product that it already approved. However, there were significant differences between its ObTape and earlier, similar products already cleared by FDA.
Although the FDA cleared OBTape, Mentor then went on to promote the unique features that made that product different and even obtain a patent to emphasize that it was a new design. Mentor ObTape injury attorneys say that the company knew that its ObTape was a new design with unique features compared to previous products and that it should have done at least minimal clinical trials to try to prevent these women from going through such terrible ordeals.