The US Food and Drug Administration (FDA) has confirmed that anaplastic large cell lymphoma (ALCL) is a rare but real risk associated with breast implants.

The FDA had recognised a possible association in 2011 but at the time concluded that more information was needed.

Since then, the World Health Organization formally designated such cases as breast implant associated anaplastic large cell lymphoma (BIA-ALCL). Australia’s TGA issued an alert about the risk in December 2016.

The FDA reported that of the 359 US cases – including nine deaths – information on the implant surface was available in 231. Of these, 203 involved a textured implant.

312 reports included information on the implant fill type – 186 filled with silicone gel and 126 with saline.

The agency recommended that physicians consider the possibility of BIA-ALCL in patients with breast implants presenting with late onset, persistent peri-implant seroma. Some cases also present with capsular contracture or masses adjacent to the breast implant.

The American Society of Plastic Surgeons advised 75% of patients required either removal of the implants and total capsulectomy or removal of a resectable mass.

About 15% of patients with advanced disease and metastasis may require further treatment such as chemotherapy.