FDA issued a warning letter yesterday to Mark Berman, MD, who has a practice in Beverly Hills, CA, for “illegally marketing an unapproved implantable device.” The so-called Pocket Protector, which FDA describes as a “pouch made of two sheets of a type of expanded polymer bonded together by silicone rubber cement,” is marketed by Berman as an implantable device that can prevent and treat breast implant complications known as capsular contracture, or tightening of the scar tissue. The pouch is designed to be implanted as a lining inside the breast pocket during breast augmentation procedures.
Capsular contracture occurs when the scar tissue around a breast implant tightens up, sometimes causing deformity and pain, said FDA in a press release distributed today announcing the warning letter. Severe cases of capsular contracture may require surgery. This usually involves removal of the breast implant and surrounding scar capsule, with or without replacement of the breast implant. FDA notes that it has “never approved any product to prevent or treat capsular contracture” and that Berman is exposing patients to a broad range of unknown health risks. These include “not effectively preventing capsular contracture, as the product claims, or causing additional harm such as infection or adverse reactions with the breast implant,” said FDA.
The warning letter also notes that the manufacturing site, “which appeared to be a multi-purpose room in Dr. Berman’s office,” in the words of FDA, is not suited for manufacturing an implantable medical device. The agency cited serious deviations from current good manufacturing practices and the potential for microbial contamination of the device. Berman also failed to establish a process for collecting and reviewing adverse event reports, which is required by FDA.
Berman must respond to FDA within 15 working days, detailing how the violations itemized in the warning letter will be corrected. The letter also requests that he immediately cease manufacturing and distributing the Pocket Protector.
Noting that this is not the first time that FDA has wrangled with Berman, FDA Commissioner Scott Gottlieb, MD, said that the agency will continue its “efforts to protect patients from those individuals who choose to skirt laws intended to keep patients safe and sell unproven and potentially unsafe medical products."
Berman is also the subject of a federal enforcement case unrelated to this product, which was filed in May 2018. In that case, the United States is seeking a permanent injunction against Berman and his California Stem Cell Treatment Center to stop them from marketing stem cell products without FDA approval.