Allergan Inc., maker of the Lap-Band Adjustable Gastric Banding System, has announced it will no longer sell the weight loss device to troubled California surgical centers affiliated with the 1-800-GET-THIN marketing company, reports The Los Angeles Times.
The Lap-Band is a medical device approved by the U.S. Food and Drug Administration (FDA) for weight loss in obese patients. Doctors insert the Lap-Band laparoscopically and place it around the upper part of the patient’s stomach to create a small pouch that limits food consumption.
In a statement, Allergan Inc. said it had “made the decision to presently discontinue the sale of the Lap-Band … to all entities affiliated with 1-800-GET-THIN.”
Allergan’s action follows the launching of investigations by local, state and federal regulators into the practices of the surgical centers and 1-800-GET-THIN.
After becoming concerned that 1-800-GET-THIN’s billboards, bus placards, newspaper advertisements, website and other marketing was misleading consumers and failing to convey the risks, the FDA sent warning letters to these companies in December telling them to stop misleading consumers:
- Marketing company 1-800-GET-THIN LLC
- San Diego Ambulatory Surgery Center, LLC
- Bakersfield Surgery Institute Inc.
- Beverly Hills Surgery Center
- Palmdale Ambulatory Center
- Valley Surgical Center
- Top Surgeons LLC
- Valencia Ambulatory Center LLC
- Cosmopolitan Plastic & Reconstructive Surgery
Some of the companies are also facing other allegations. Five patients who underwent Lap-Band surgery at clinics associated with 1-800- GET-THIN have died. California regulators are looking into the deaths and the families of some patients have filed lawsuits.
Medscape News reports that ex-employees and patients of the surgical centers have filed a lawsuit claiming the surgical centers performed Lap-Band and other medical procedures with staff personnel that were unqualified, in facilities that were unsanitary and utilized malfunctioning equipment.
Their lawsuit alleges:
- Owners and staff at the Beverly Hills Surgery Center covered up the events leading up to the death of one patient;
- Failure to maintain equipment and possess ventilators large enough for obese patients.
- High incidence of post-operative infections due to substandard sanitation policies and inadequate equipment;
- Unqualified nurses in operating rooms, nurses operating as surgeons and unsupervised administration of anesthesia;
- Performing unnecessary procedures.
Owners of the surgery centers deny all the allegations.
“Our surgery centers are staffed with experienced bariatric surgeons, trained by Allergan on the proper procedures for implanting the Lap-Band,” a representative of the surgery centers said in a statement to KTLA News. “Patients interested in weight loss solutions have a range of options, of which the Lap-Band is only one. We will continue to work with our patients to find the best healthcare options for their medical needs.”
Allergan will continue to sell Lap-Band to other medical facilities and bariatric surgeons.