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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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oBand Centers Westwood, CA 11/2/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

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

 

WARNING LETTER
 
November 2, 2012
 
VIA UNITED PARCEL SERVICE
 
 
Isaac Verbukh
Registered Agent
oBand Centers
4333 Admiralty Way
Marina Del Rey, California 90292-5469
 
Refer to GEN1001514 when replying to this letter.
 
Dear Mr. Verbukh:
 
The Food and Drug Administration (FDA) has learned that the oBand Centers are marketing the LapBand gastric banding system 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.
 
FDA approved the LapBand on June 5, 2001, for use in weight reduction for certain severely obese adults. See approval order and approved labeling  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p000008
The Office of Compliance, in FDA’s Center for Devices and Radiological Health, has reviewed oBand Centers’ website at www.obandcenters.com (last visited on October 25, 2012). For the reasons described below, the claims on the website misbrand and adulterate the Lapband.   
 
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, 21 U.S.C. § 352(q), 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, 21 U.S.C. § 321(n), in determining whether a device’s labeling or advertising is misleading, the extent to which the labeling or advertising fails to reveal material facts shall be taken into account.
 
oBand Centers’ website fails to reveal material facts regarding the risks posed by the LapBand device. For example, on the webpage at www.obandcenters.com/right_risks.asp, under the heading, “Risks,” the website states the following:
 
The incidence of complications for lap band procedures world wide is extremely low. The rate of complications for specific doctors at specific facilities can vary substantially. Our doctors are among the few nationally recognized lap band specialists who have the best success rates and the lowest complication rates. During your consultation the surgeon will discuss his/her personal success and complication rates and compare them to the world wide statistics.
 
This significantly understates the risks posed by the device, for example by failing to mention the risk of death or serious injury from gastric band surgery (such as damage to the liver, spleen, and major blood vessels, lung problems, blood clots, infection, gastric perforation (which, if it occurs after the procedure, may require additional surgery), esophageal dilatation, severe vomiting and a significant rate of revision surgery) and the fact that such surgical risks are greater for patients who are obese or have other underlying medical conditions. 
 
oBand Centers’ webpage at http://www.obandcenters.com/right_procedure.asp, shows a copy of the Allergan LapBand video. Although the end of the video includes what is titled, “A Brief Description of Relevant Indications For Use, Contraindications, Warnings and Adverse Events For the Lap-Band System,” the information shown is not accessible to the viewer both because of the brief appearance of the information as well as the tiny and blurry print, which renders the content illegible.
 
Therefore, oBand Centers’ promotional materials are misleading within the meaning of section 201(n), 21 U.S.C. § 321(n), of the Act and misbrand the LapBand under section 502(q), 21 U.S.C. § 352(q), of the Act. FDA requests that the oBand Centers immediately cease marketing the LapBand using promotional materials 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. Please provide a translation of documentation not in English to facilitate our review. Your response should be sent to:
 
Deborah Wolf
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
WO66-3521
Silver Spring, MD 20993
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the oBand Centers’ violations of the Act.  It is the firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.
 
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
    Radiological Health