Inspections, Compliance, Enforcement, and Criminal Investigations
Valencia Ambulatory Surgery Center, LLC 12/9/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
DEC 9 2011
VIA UNITED PARCEL SERVICE
CEO and Principal
Valencia Ambulatory Surgery Center, LLC
25775 McBean Parkway
Valencia, CA 91355
Refer to GEN1001514 when replying to this letter.
Dear Ms. Omidi:
The Food and Drug Administration (FDA) has learned that, through means including the entity 1-800-GET-THIN, the Valencia Ambulatory Surgery Center, LLC 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 function of the body. Your 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 material 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 follow:
1. We reviewed two photos of billboards. The billboards read:
“LOSE WEIGHT WITH THE LAP-BAND! SAFE 1 HOUR, FDA APPROVED
1-800-GET-THIN; 1-800-953-5000; PPO INSURANCE; FREE INSURANCE
“MARCIANO LOST 125 POUNDS; LAP-BAND WEIGHT LOSS REVOLUTION!
CALL 1-800-GET-THIN; 1-800-953-5000; PPO INSURANCE; FREE INSURANCE
2. We also reviewed several advertising inserts. One insert reads, “Celebrate Black History Month! Let Your New Life Begin! 1-800-GET-THIN.” The other insert reads, “Significantly Overweight? CALL: 1-800-GET-THIN.” The text and photograph on the back of both inserts are the same. In large text is the statement, “LET YOUR NEW LIFE BEGIN!” Below the text is a photograph of a woman with a caption that reads, “I LOST 130 POUNDS.” In very small print below the woman’s photograph is the following text:
“You may be a candidate for the LAP-BAND® if your BMI is over 40 or between 35 and 40 with other specific medical conditions. The LAP-BAND® procedure has certain risks, side effects and contraindications. Consult your physician before deciding if the LAP-BAND® is right for you. For more information visit, www.1800getthin.com/safety. Typically with the LAP-BAND®, 1-2 pounds of weight loss per week and 50-70% of excess weight lost and maintained at 5 years can be expected.”
Below this language is the final caption, printed in very large font: “GET THE LAP-BAND! CALL NOW! 1-800-GET-THIN HOURS: 6:30AM - IOPM • (1-800-540-8000) BEVERLY HILLS| WEST HILLS|VALENCIA|PALMDALE|APPLE VALLEY| BAKERSFIELD|COVINA|SANTA ANA|LONG BEACH|SAN BERNARDINO| SAN DIEGO”
Another insert features a woman named Christine. Above her photo, in very large print, is the caption, “I LOST 90 POUNDS WITH THE LAP-BAND!” Next to her photograph, the following testimonial is printed:
“I'm Christine. I have lost 90 pounds with the Lap-Band! I struggled forever to lose weight. I tried everything! Crazy diets, workout videos, personal trainers. I always ended up back at the same weight. The Lap-Band has helped thousands of happy people safely and effectively lose weight and keep it off! . . .The Lap-Band is changing lives one pound at a time. If you are ready to lose weight, pick up the phone and call 1•800- GET THIN. You can lose the weight with the Lap-Band just like I did.”
Following the testimonial the caption reads, “Free Seminar at a Location Near You! Covered by PPO Insurance. LOSE WEIGHT NOW! Call Now For Your FREE Lap-Band Guide.” Below this statement is cautionary information in small font, which provides, “Consult your physician to discuss risks and other options. See 1800GETTHIN.com/safety. Studies show about a 50% - 60% excess weight loss at 3 years. The final text located on the bottom of the insert in very large print is 1-800-GET-THIN Hours 7am-10pm 1-800-953-5000.”
These advertisements 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. In addition, while some of your advertisements make mention of risks and suggest a physician consultation, these advertisements do not adequately state the LapBand’s relevant warnings, precautions, side effects, and contraindications. Therefore, the advertisements also misbrand the LapBand under section 502(r) of the Act.
Note also that we are concerned that the information your firm does provide related to risks is in font that may be so small as to render the information illegible.
FDA requests that Valencia Ambulatory Surgery Center, LLC, immediately cease marketing the LapBand using advertising that violates the Act. Your 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 your firm has taken to correct the noted violations, including an explanation of how your 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. Please provide a translation of documentation not in English to facilitate our review. 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 your firm’s violations of the Act. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.
Steven D. Silverman
Office of Compliance
Center for Devices and