The US Food and Drug Administration (FDA) has sent a warning letter to a physician in Beverly Hills, California, for illegally marketing an unapproved implantable device, called the Pocket Protector, which he claims can prevent and treat capsular contracture, a known complication of breast implants.
The FDA has never approved any product to prevent or treat capsular contracture.
By illegally manufacturing and marketing this device, Mark Berman, MD, 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," FDA Commissioner Scott Gottlieb, MD, said in a statement released today.
Capsular contracture occurs when the scar tissue around a breast implant becomes tight, sometimes causing deformity and pain.
The Pocket Protector is a pouch made of two sheets of a type of expanded polymer bonded together by silicone rubber cement that is implanted as a lining inside the breast pocket during breast augmentation procedures, the FDA explained.
Berman has unlawfully marketed the medical device through his website and through promotional videos touting the Pocket Protector as safe and beneficial for treating or preventing capsular contracture, even though the product has never been evaluated by the FDA for safety or efficacy with regard to that or any other use, the agency said.
The warning letter also discusses findings of a recent FDA inspection of the Pocket Protector manufacturing site, which appeared to be a multipurpose room in Berman's office and was "inadequate" for the manufacture of an implantable, sterile device, the FDA said.
FDA investigators found evidence of "many significant deviations" from current good manufacturing practices, including unvalidated manufacturing processes, lack of control over the components used in production, and the lack of sufficient, validated product testing.
These deviations could lead to "serious" patient harm, including the potential risk for microbial contamination, the FDA said. Berman also failed to establish a process for collecting, identifying, and reviewing medical device reports of adverse events associated with use of the Pocket Protector, as required by FDA regulations, the agency said.
It's not the first time the FDA has warned Berman about the illegal marketing of unapproved medical products. The FDA announced in May 2018 that it was seeking a permanent injunction to stop Berman and his California Stem Cell Treatment Center from marketing unapproved stem cell products.
"Advancing and protecting women's health is a priority for the FDA. As part of these efforts, we will not tolerate bad actors who take advantage of patients by marketing unapproved and potentially unsafe products that deceive patients and put them at risk," Gottlieb said.
"We'll continue our 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," said Gottlieb.
Medscape Medical News © 2019
Cite this: FDA Warns 'Bad Actor' Doc Over Illegal Marketing of Breast Device - Medscape - Feb 14, 2019.
Comments