The FDA today announced that it has issued warning letters to eight
California surgical centers and a marketing firm for misleading advertising of
Lap-Band.
The FDA issued warning letters to Bakersfield Surgery Inc; Beverly Hills
Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top
Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic &
Reconstructive Surgery; San Diego Ambulatory Center LLC; and the marketing firm
1-800-GET-THIN because these groups misrepresented Lap-Band (Allergan), which
is a restricted medical device, according to the press release.
In the letters, the FDA warns that billboard and advertising inserts
used by the groups to promote the
Lap-Band procedure fail to provide required risk information,
including warnings, precautions, possible side effects and contraindications.
Further, the FDA expressed concern that the font size of information related to
risks on the advertising is too small to be read by consumers.
“The FDA takes seriously its responsibility to protect consumers
from products promoted without adequate warnings,” Steve Silverman,
director of the Office of Compliance in the FDA’s Center for Devices and
Radiological Health, said in a press release. “It’s particularly
troublesome when advertisements don’t communicate the serious risks
associated with medical devices.”
If the companies do not amend their advertising and promotion
strategies, the agency may take further action, such as product seizure or
civil money penalties, the release stated.
“The decision to undergo a gastric banding procedure should be done
in close consultation between a patient and his or her health care
provider,” Kimber Richter, MD, deputy director for medical affairs
in the Office of Compliance in the FDA’s Center for Devices and
Radiological Health, said in the release. “It is important for the patient
to fully understand both the risks and the benefits of the procedure and for
the health care provider to be sure the procedure is appropriate for the
patient.”