The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures.
In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices.
“This is not the first time the FDA has notified Dr. Berman concerning his illegal marketing of unapproved medical products and potentially putting his patients at significant risk. Dr. Berman is well aware that the FDA has never approved any product to prevent or treat capsular contracture. By illegally manufacturing and marketing this device, Dr. 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,” FDA Commissioner Dr. Scott Gottlieb said in a press release.
The illegally marketed Pocket Protector is made of two sheets of expanded polymer bonded together by silicone rubber cement to make a pouch, and is intended to be implanted as a lining inside the breast pocket during augmentation procedures, according to the FDA release.
“The agency has never approved any implantable device for use in preventing or treating capsular contracture,” Gottlieb said in the posting. “Such a device would require premarket approval by the agency. Dr. Berman unlawfully marketed the unapproved product via a website and through promotional videos telling the public that the Pocket Protector was safe and beneficial for treating or preventing capsular contracture, even though the product has never been evaluated by the FDA for safety or efficacy for that or any use.”
The warning letter also included a recent inspection of Dr. Berman’s office, in which officers of the agency found the manufacturing site “inadequate for the manufacture of an implantable, sterile device.”
FDA investigators noted significant deviations from guidelines, including unvalidated manufacturing processes, lack of component control and a potential risk for microbial contamination.
“The warning letter requests that Dr. Berman immediately cease manufacturing and distributing the Pocket Protector,” Gottlieb wrote in the warning.
The new warning letter from the FDA isn’t the first time Dr. Berman has been under federal scrutiny.
Last year, Dr. Berman and associate Dr. Elliot Lander became the focus of a U.S. Department of Justice complaint for permanent injunction for allegedly offering unproven stem cell treatments at clinics in Southern California, according to an FDA release.
The same complaint also targeted Sunrise, Fla.-based US Stem Cell Clinic chief scientific officer Kristin Comella and co-owner Theodore Gradel for marketing similar unapproved stem cell products, according to the release.
The agency claims that Dr. Berman controls the operations of the California Stem Cell Treatment Center, the Cell Surgical Network Corporation and approximately 100 affiliates, which offered unapproved stem cell therapies. The order requested that all of the clinics “cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.”
In 2017, the U.S. Marshals Service, on behalf of the FDA, seized five vials of Vaccinia Virus Vaccine (live), a vaccine reserved for individuals at high risk of small pox, such as U.S. military members. The vaccine was being mixed with a cellular product derived from fat and was being administered to cancer patients with potentially compromised immune systems, the FDA said.
Dr. Berman’s centers also offered stem-cell based products for a variety of experimental treatments for serious diseases and conditions including cancer, arthritis, stroke, amyotrophic lateral sclerosis, multiple sclerosis, macular degeneration, Parkinson’s disease, chronic obstructive pulmonary disease and diabetes, according to the FDA release.
“The FDA has not approved any biological products manufactured by California Stem Cell Treatment Center for any use,” the FDA wrote in its notice.