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FDA Warns Doctor Over Unapproved Device

Posted 14 February 2019 | By Ana Mulero 

FDA Warns Doctor Over Unapproved Device

In a 14-violation US Food and Drug Administration (FDA) warning letter, the agency flagged a doctor’s website for significant deviations from FDA quality system requirements and good manufacturing practices (GMP), as well as illegally marketing an unapproved device for a complication of breast implants.

The warning letter was issued to Mark Berman of Beverly Hills, California for marketing the implantable Pocket Protector device online with claims and use indications that require FDA approval.

The website’s page on breast augmentation goes on to claim that while the material used for the Pocket Protector “has been used in general and vascular surgery for many years, it was first introduced into cosmetic/plastic surgery in 1983 (by me) and is still commonly used.” FDA, however, debunked these claims in the warning letter. The agency “is not aware of an implantable device intended for use with breast implants, such as yours, that is legally market for this use,” Shari Shambaugh, a program division director at FDA’s Center for Devices and Radiological Health (CDRH), wrote in the warning letter.

As a result of the agency’s inspection of Berman’s website, CDRH determined that the Pocket Protector requires an approved premarket application approval as a class III medical device. The agency also disagreed with Berman’s assertion in his July 2018 response to the FDA Form 483 that the Pocket Protector qualified for the custom device exemption of the FD&C Act as it did not meet certain specified criteria, such as a five-unit yearly limit on the production of a device type and annual reports to FDA.

FDA Commissioner Scott Gottlieb highlighted the concerns regarding claims around using the Pocket Protector device for the prevention and treatment of a complication of breasts implants known as scar tissue tightening.

“Berman is taking advantage of patients and exposing them to a broad range of unknown health risks, including not effectively preventing capsular contracture as the product claims or causing additional harm such as infection or adverse reactions with the breast implant,” Gottlieb said.

Berman was directed to immediately cease manufacturing and distributing the Pocket Protector. The agency deemed the device adulterated over the 14 violations—each of which cite failures to meet GMP requirements of the device quality system regulation. These violations relate to failure to establish complaint handling procedures and maintain a device master record, among several other requirements. Further, the device was also deemed misbranded over a lack of medical device reporting procedures to report adverse events. Berman did not immediately respond to a request for comment.

Warning letter

 

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