![]() This condition occurs when the scar tissue around a breast implant becomes tight, sometimes causing deformity and pain. 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.Ĭapsular contracture is a known complication of breast implants. 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 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. 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.” 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. By illegally manufacturing and marketing this device, Dr. Berman is well aware that the FDA has never approved any product to prevent or treat capsular contracture. Berman concerning his illegal marketing of unapproved medical products and potentially putting his patients at significant risk. “This is not the first time the FDA has notified Dr. 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. “Advancing and protecting women’s health is a priority for the FDA. 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. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue. ![]() 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.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |