The Medicines and Healthcare products Regulatory Agency (MHRA) says it has no plans to ban specific types of breast implants after the French regulatory authority (ANSM) took the decision last week to restrict the use of macrotextured breast implants and breast implants with polyurethane-coated surfaces.
The MHRA says it convened a meeting of its Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group to re-examine the data in the wake of the French decision. Based on an analysis of the latest scientific evidence, the group has concluded that “there has been no new evidence of an increased risk to patients above what is already known and there is no need for people with breast implants to have them removed”.
As of February 2019, the MHRA had received 62 reports of anaplastic large cell lymphoma (ALCL) in patients with breast implants, of which 52 met the 2016 World Health Organization (WHO) diagnostic criteria for breast implant-associated (BIA) ALCL.
Of the total number of women with ALCL, there have been three deaths but only one of these has been confirmed to meet the WHO diagnostic criteria.
In the United Kingdom, the estimated risk for BIA-ALCL, based on the reported confirmed cases, is one per 24,000 implants sold.