Silimed’s CE Certificate for Silicone Implants in the European Market Suspended by The Medicines and Healthcare Products Regulatory Agency
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHPRA) made the decision on September 23, 2015, to suspend silicone implants manufactured by Silimed for concerns over potential particulate contamination.
Silimed is working with European agencies to provide technical documentation to resolve MHPRA's concerns. Additionally, Silimed has voluntarily suspended the sale of its products in the European market until health authorities receive Silimed's official technical report. Silimed has also reinforced through company statements that this issue is exclusively connected with the guidelines of the sanitation policy of the European Community and it complies with the other regulations in effect in other markets.
ASPS will continue to monitor this effort very closely and provide updates to members as new information is learned. At this time we do not have information that suggests that this issue poses a threat to patients in the US. The health of breast augmentation and reconstruction patients is a high priority for the ASPS as demonstrated by our efforts to develop the National Breast Implant Registry (NBIR) for ongoing device surveillance and the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) to better understand breast implant associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). The ASPS and The Plastic Surgery Foundation are committed to developing clinical data tools to ensure patient safety and quality care of plastic surgery patients.
Silimed is a Brazilian company that has been manufacturing silicone implants for 37 years with product approvals in 75 countries. In 2007, Sientra acquired the rights to sell Silimed breast implants in the United States. In 2012, Sientra received FDA approval of its Silimed-brand portfolio of round and shaped silicone breast implants.
In a statement Sientra noted - "The MHRA announcement has no applicability to Sientra's products as it is applicable only to the distribution of Silimed's CE-marked implants in Europe." Hani Zeini, Founder and Chief Executive Officer Sientra, Inc., said. "Our products are FDA-regulated and PMA-approved. Sientra's breast implants and our other products continue to be marketed and available in the United States and there has been no change to the regulatory status of Sientra's FDA-approved breast implants."
The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world. Representing more than 11,000 physician members worldwide, the society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery. ASPS comprises more than 92 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada.