Right now the Food and Drug Administration (FDA) is considering a decision that would expose millions more women to a surgical device with no evidence that it will improve their health. The lap-band, an implanted weight-loss device, is already approved for people who are classified as severely obese, but the company wants to expand its use to the millions of people at the lower end of the obesity range.
The Network believes that if a woman chooses to undergo weight-loss surgery, she should have the FDA's assurance that the evidence shows it will improve her health, not simply reduce the number on the scale. Obesity is associated with serious and life-threatening conditions, such as diabetes, hypertension, and heart disease. Although research shows that many women who have a lap-band are able to achieve weight-loss in the short-term, weight loss in and of itself doesn’t necessarily improve a person’s health and the company has not provided evidence that people experience meaningful health benefits beyond short-term weight-loss.
It is not too late for you to take action – the FDA will soon make its decision about expanding the use of this device. The National Women’s Health Network has written to remind the FDA that there are too many unanswered questions about the long-term safety and effectiveness of this device. You can add your voice to the Network’s by telling the FDA to do the right thing and reject the expansion of the lap-band!
Click here to send this message to the FDA.
Depending on your web browser you may have a problem viewing the message in the link. Below is the message you can send to the FDA.
Dear Dr. Shuren,
I am writing to ask the FDA to reject an expanded use of the lap-band for people at the lower end of the obesity range; there are too many unanswered questions about its long-term safety and effectiveness.
This device is already approved for people who are classified as severely obese, but this change would more than double the market, exposing millions of patients – mostly women – to the risks of serious abdominal surgery and the long-term risks of an implanted device, without evidence that it will improve their health.
Although research shows that many women who have a lap-band are able to achieve short-term weight-loss, weight loss in and of itself doesn’t necessarily improve a person’s health. Before considering expanded use, the FDA should require evidence that people experience meaningful health benefits beyond short-term weight-loss.
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Dr. Jeffrey Shuren
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