A group of women are suing Mentor Corporation, creator of ObTape, a urinary incontinence treatment option, bringing to light scary situation in the how the F.D.A. operates.

According to a New York Times, "the lawsuits raise new questions about the process by which the F.D.A. reviews new medical devices. While it 'approves' drugs, it merely 'reviews' medical devices, such as ObTape, with minimal testing if they are deemed 'substantially equivalent' to devices already in use."

ObTape is such a medical device that has shallow roots in other urinary incontinence treatment devices that have since been called off the shelves due to medical problems and severe side effects in patients.

The article tells that reports of "adverse events linked to ObTape" that began to pour into the F.D.A, all describing terrible side effects.

The F.D.A. needs to make better and more stringent protocols for its testing of medical devices. Medical devices are as readily relied upon as drugs are; patients deserve to have the same confidence in their medical devices as their drugs. At AllMed, an independent review organization, we ensure that every treatment method we recommend is evidence-based and the absolute best and most fitting treatment method for your patient.

To read the full article, click here: http://www.nytimes.com/2009/05/05/health/05tape.html?pagewanted=2&_r=2&ref=health