Subject: Medical Device/Misbranded
Issuer: Center for Devices and Radiological Health
Issued: June 25, 2012 Closed:
Not Issued
Source ucm311416 Archive Code:
20170404201813 6/25/12

Department of Health and Human Services

Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

JUN 25 2012
Via United Parcel Service
Hooman Shabatian, M.D.
Lap-Band VIP
5879 W Pico Boulevard
Los Angeles, California 90019-3717
Refer to CPT 1200101 when replying to this letter.
Dear Dr. Shabatian:
The Food and Drug Administration (FDA) has learned that LAP-BAND VIP is marketing the LapBand gastric banding system (LapBand) in the United States (U.S.) in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The LapBand is a device within the meaning of Section 201(h) of the Act, § 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. LAP-BAND VIP’s promotion of the LapBand misbrands the device under sections 502(q), 502(r), and 201(n) of the Act, 21 U.S.C. §§ 352(q), 352(r), and 321(n).
Under section 515(d)(1)(B)(ii) of the Act, 21 U.S.C. § 360e(d)(1)(B)(ii), FDA may require as a condition of approval of a device that the sale and distribution of the device be restricted to the extent permitted under section 520(e) of the Act, 21 U.S.C. § 360j(e). FDA’s approval of the LapBand restricted this device by requiring that it only be sold and distributed upon authorization by a licensed practitioner (i.e., under prescription). Section 502(q) of the Act provides that a restricted device is misbranded if its advertising is false or misleading in any particular. According to section 201(n) of the Act, in determining whether a device’s labeling or advertising is misleading, the extent to which the labeling or advertising fails to reveal material facts must be taken into account. In addition, a restricted device is misbranded under section 502(r) of the Act if the device’s distributor does not include in all advertisements and other descriptive printed materials a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications.
Examples of the advertising pieces we reviewed that misbrand the LapBand are described below.
1. We reviewed the text of two television commercials. The text from the commercials follows:
Commercial 1
“I tried a lot of different weight loss programs but they just didn’t work for me. I saw some pictures of myself at a party and I didn’t recognize myself and I knew I had to make a change. Hi I’m Pam [sic] I had the LapBand done two years ago and I’ve lost 90 pounds. After the LapBand my kids have to keep up with me. We play basketball, we play soccer, we go hiking.
Go to the website, sign up for a free seminar – you can also do over [sic] the phone if you like, it’s the best thing you can do for yourself. Visit LapBand for a free PPO verification. Better Care – Better results.”
Commercial 2
My weight made me feel like I couldn’t participate in activities with my friends and family. When my doctor told me that I could actually die because of my weight. [sic]That’s when I made my decision to change my life and I called LapBand VIP. LapBand VIP brought out the best in me. After LapBand VIP I can now ride my Quad, walk my dog and play golf with the best of them. Make the change today call LapBand VIP.
In addition to the television commercials, we also reviewed billboards advertising Lap-Band VIP. The text of the billboards reads as follows:
Billboard 1
“LAP-BAND VIP. Your Success is Our Success. Lose up to 50LBS or more! (909)297-3337.”
Billboard 2
“LAPBANDVIP.COM. 800.561.9000. PPO INSURANCE VERIFICATION.” There is a photo of a thin woman with the caption: “TIFFANY LOST OVER 100 LBS. Actual Patient. Results May Vary.”
These advertisements all fail to reveal material facts, including relevant risk information regarding the use of the LapBand, age and other qualifying requirements for the LapBand procedure, and the need for ongoing modification of eating habits, as provided in the approved LapBand labeling. Therefore, the advertisements are misleading within the meaning of section 201(n) of the Act and misbrand the LapBand under section 502(q) of the Act. Additionally these advertisements do not provide the LapBand’s relevant warnings, precautions, side effects, and contraindications. Therefore, the advertisements also misbrand the LapBand under section 502(r) of the Act.
FDA requests that LapBand VIP immediately cease marketing the LapBand using advertising that violates the Act. The firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. Such action could include seizure, injunction, and civil money penalties.
Please notify this office in writing within fifteen working days from the date you receive this letter of the specific steps the firm has taken to correct the noted violations, including an explanation of how the firm plans to prevent these violations, or similar violations, from occurring again. Include documentations of the corrective actions taken.
If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be sent to:
Terri T. Garvin
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
Silver Spring, MD 20993
Finally, you should know that this letter is not intended to be an all-inclusive list of the firm’s violations of the Act. It is the firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.
Sincerely yours,
Steven D. Silverman
Office of Compliance
Center for Devices and
Radiological Health