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Warning Letter Analysis: Device Companies Hit for Marketing, Social Media Problems

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By Alexander Gaffney

Alleged marketing deficiencies were the subject of nearly identical warning letters sent to two separate manufacturers of hypoerthermic medical devices, both of whom were accused of using online advertisements to promote their respective devices for conditions not cleared or approved by the US Food and Drug Administration (FDA).


ThermaSolutions Incorporated (Medical Device) See: 22 June 2012 Update

In its 7 May warning letter to Minnesota-based medical device manufacturer ThermaSolutions, FDA took aim at alleged violations within ThermaSolution’s online marketing of its TheremoChem-HT System, which the agency noted is cleared through the 510(k) process.

The device is used under approved conditions to raise the core temperature of the peritoneum, but FDA said the company was marketing the product on its website as a means to heat chemotherapy drugs injected during cancer treatments (hyperthermic intraperitoneal chemotherapy, or HIPEC).

FDA also called attention to a piece of marketing in which ThermaSolutions’ marketing team managed to get the TV show “Grey’s Anatomy” to feature the product in an episode. In materials accompanying its highlight of the episode, ThermaSolution said the device was positioned “to make sure the procedure and equipment was used the way our clients do too.”

The company’s Twitter page also received FDA attention after the agency noted the company was claiming it had clearance for use as a HIPEC device, which it does not.

While FDA ordered the company to immediately remove all marketing violations, as of 13 June the company had not yet removed references to the Grey’s Anatomy show from its website, though it seemed to have scrubbed its main webpage and Twitter account of nearly all references to HIPEC.

[Editor's note: Regulatory Focus received comment from Steve Stonelake of Thermasolutions on 22 June saying the company "had removed all references to the Grey's Anatomy" episode from its website. The webpage listed above on 13 June no longer functions.]


Belmont Instrument Corporation (Medical Device)

Massachusetts-based medical device manufacturer Belmont Instrument Co. might not have gotten its products placed on a TV show, but it nevertheless received a warning letter similar to one received by ThermaSolutions. In a 7 May warning letter sent to Belmont’s President, George Hertzlinger, FDA said the company was marketing its Belmont Hyperthermia Pump as a HIPEC device despite failing to get clearance for the condition under the 510(k) process.

As of 13 June, Belmont had entirely deleted its website marketing its Hyperthermia Pump per FDA’s request to remove all violative marketing materials from its website.




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