The U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue.
The warning letter also notifies Dr. Berman of significant deviations from the FDA’s quality system requirements and current good manufacturing practices (CGMPs), including deviations from manufacturing processes intended to keep implants sterile.
“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,” said FDA Commissioner Scott Gottlieb, M.D.
“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. 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.”
The warning letter issued today reflects the agency’s commitment to advancing policies that enhance the FDA’s oversight of device safety, including device therapies unique to women. As part of the Medical Device Safety Action Plan and the agency’s ongoing commitment to advancing women’s health, the FDA has warned the public when safety issues are identified, such as breast implant-associated anaplastic large cell lymphoma, vaginal rejuvenation and unsafe silicone injections.
The agency has also established the Women’s Health Technologies Strategically Coordinated Registry Network to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.
Capsular contracture is a known complication of breast implants. This condition occurs when the scar tissue around a breast implant becomes tight, sometimes causing deformity and pain. 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. Capsular contracture may be more common following infection, injury to blood vessels (hematoma) or fluid buildup under the skin (seroma). However, the cause of capsular contracture is not known.
The medical device that Dr. Berman is illegally marketing to patients under the name 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 agency has never approved any implantable device for use in preventing or treating capsular contracture. 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.
In addition, the warning letter discusses the FDA’s recent inspection of the Pocket Protector manufacturing site, which appeared to be a multi-purpose room in the Dr. Berman’s office. The agency found the manufacturing site to be inadequate for the manufacture of an implantable, sterile device. Investigators documented evidence of many significant deviations from CGMPs, including unvalidated manufacturing processes, lack of control over the components used in production, and the lack of sufficient and validated product testing.
These significant deviations could lead to serious patient harm, including the potential risk of microbial contamination. Additionally, the FDA noted that Dr. Berman had 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 warning letter requests that Dr. Berman immediately cease manufacturing and distributing the Pocket Protector. It also asks him to respond, within 15 working days from the date the warning letter was received, with details of how the violations noted in the warning letter will be corrected. Any violations not corrected could lead to enforcement action such as seizure, injunction, or prosecution.
Separate from the violations noted in this warning letter, Dr. Berman’s marketing of other FDA-regulated products without FDA approval is currently the subject of a federal enforcement case that was filed in May 2018. In that case, the United States is seeking a permanent injunction against Dr. Berman and his California Stem Cell Treatment Center to stop them from violating the law by marketing stem cell products without FDA approval.
Health care professionals and consumers should report any adverse events related to treatments with the Pocket Protector product to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: Company Press Release