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The New York Times recently reported on a 40 year old female who was diagnosed with Stress Urinary Incontinence and instead of proven, non-invasive pelvic floor exercises was offered a ‘quick and easy surgery’ using Mentor’s ObTape (a tape mesh) to support her bladder as a remedy. Three years and 5 surgeries later she experiences chronic vaginal discharge, chronic pain and severely reduced quality of life.

This story is shocking on several levels. First, stress incontinence is often easily cured by exercises to strengthen the pelvic floor musculature. The woman in this article was a runner working on a black belt in Karate. She clearly believed in the value of exercise and enjoyed exercising to keep fit. Why wasn’t she told about Kegel exercises or taught Kegel exercises? Why wasn’t she told about one of the many inexpensive biofeedback devices for incontinence? Or why wasn’t she referred for Physical Therapist for professional training in strengthening the pelvic floor muscles? All of these options are less expensive than surgery and extremely effective. If she truly was not told about these alternatives to surgery, then I believe the doctor is guilty of malpractice. For a surgeon to recommend surgery as the only option is all too common but when alternatives are not even discussed it certainly looks like the surgeon is recommending what is best for the surgeon rather than the patient. So, the ethics of the doctor’s recommendation is in question in this case.

Then we find out that this ObTape mesh device was cleared by the FDA because it was substantially the same as a previously reviewed device ‘that caused so much harm it was taken off the market’. Can we really trust the FDA to protect us? Is the FDA review process transparent? Is the FDA’s review process really concerned with protecting the consumer?

Congress should begin to investigate the FDA and their pro-business practices the same way they have started to investigate physician payoffs by drug companies.

The days when we can blindly trust a doctor’s recommendation are over. Always, always get a second or third opinion (one of which is a non surgical opinion if surgery is recommended). Always ask lots of questions. Always ask about alternatives. Always do the least invasive technique first, you can always escalate if necessary. The least invasive technique may take some time and energy but it is almost always best to start there first.

For more personal stories about the problems with ObTape read an ObTape victim’s blog.

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