The Lap-Band is an inflatable banding system that is placed around the upper stomach to limit
food intake in severely
obese individuals. The Food & Drug Administration (FDA) gave BioEnterics' Inamed unit permission to market the Lap-Band in June 2001.
However, recent concerns have surfaced regarding the safety of the
medical device. Some
doctors now think that the FDA's approval was premature.
The FDA's action approved Lap-Band for use only in patients at least 100 pounds overweight or patients who are at twice their ideal body weight and who have failed to lose weight by diet and exercise.
The FDA concedes that nearly 90% of the patients in a Lap-Band study experienced at least one of the following side effects:
nausea, vomiting, abdominal pain,
heartburn and slippage of the band. Additionally, nearly 25% of the participants had the band removed due to such side effects or inadequate weight loss.
According to a four-year study of the first 36 users of Lap-Band, the primary reasons for removing the gastric device included
infection, leakage, and band slippage.
The FDA approved Lap-Band based upon a comparison of its risks and benefits. Severely obese people are at serious risk of developing health problems such as
hypertension (high blood pressure),
heart disease and
diabetes.
See your doctor if you have experienced serious health problems after receiving the Lap-Band device. In addition, it may be important to
contact an attorney who can help you protect your legal rights. Please keep in mind that there may be
time limits within which you must commence suit.
Attorneys associated with InjuryBoard.com will evaluate your case
free of charge. In addition, you will not pay any fees or costs unless your attorney recovers money for you. Please click on the free
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See Also
- Medical Devices & Implants
- Digestive Disorders: Overview
- Nausea: Overview