|Patient / Public:||
5 (7 votes)
1-800-GET-THIN LLC was warned in what the FDA considers “misleading advertising for lap-band surgery.” Potential surgery candidates along with patients who view or respond to advertising for lap-band surgery are “not being adequately informed of potential downsides to the surgery,” said the FDA. 1-800-Get-THIN LLC as well as another 8 additional surgery centers in the state of California were told to stop misleading people about the lap-band which is a medical device that has been approved for use by the FDA to assist obese adults in weight loss. FDA officials accused these surgical centers of leaving out important negative side effects from the Lap-Band surgery, including contraindications, potential side effects, warnings, and precautions.
These companies in California following have been sent warning letters by the FDA:
- Palmdale Ambulatory Center
- Valley Surgical Center
- Bakersfield Surgery Institute Inc
- Top Surgeons LLC
- San Diego Ambulatory Center LLC
- Beverly Hills Surgery Center
- Cosmopolitan Plastic & Reconstructive Surgery
- Valencia Ambulatory Center LLC
The main point of their message was that Lap-Band surgery, as a specifically restricted device, has been misbranded through misleading and incomplete advertising.
The Food and Drug Administration (FDA) mentioned additionally that negative facts regarding the medical device appear in a smaller-than-necessary-font size in advertisements, leading to consumers not noticing, not reading, or disregarding.
Steve Silverman who is the Office of Compliance director of the Food and Drug Administration’s Center for Devices & Radiological Health, stated:
“The FDA [regards] seriously its responsibility [in protection of consumers from products that do not include] adequate warnings. [Especially] when [these] advertisements [do not] communicate… risks associated…”
The surgical companies have been advised by FDA officials that fines, product seizures, or more could result if FDA concerns from warning notices are not addressed.
What is a Lap-Band Surgery?
A Lap-Band Surgery which is also called a (Laparoscopic) Adjustable Gastric Band, consists of a silicone device which is surgically inserted around a portion of stomach lining. The lap-band is utilized in treating patients whose body mass index (BMI) is between 30-40 (which defines obese).
The overweight patient who is a candidate for Lap-Band surgery may also have obesity related conditions, like hypertension (high blood pressure), type 2 diabetes or more. Physicians typically consider lap-band when previous other attempts and therapies have not been successful in assisting the patient to lose weight. Diet, exercise, and behavioral changes are always preferred to invasive procedures.
Patients who choose Lap-Band surgery must be committed significant lifestyle, exercise, and eating changes.
Patients who are under 18 are prohibited from having Lap-Band surgery. FDA officials say that this is an example of a limitation to the lap-band and it is crucial that patients and family understand the limitations and risks of the surgery before receiving it.
Physicians and other medical professionals and providers are bound by law to educate their patients regarding risks. Lap-Band advertisement and promotions need to explain risks in a clear and visible form.
Individuals with complications or problems who believe that issues are occurring with their surgery are encouraged to file reports voluntarily directly with the FDA. The Food and Drug Administration uses and concludes that these important reports are helpful in identifying, understanding, and communicating any risks associated with specific medical devices.