Breast implants can cause a rare and hard-to-treat form of cancer, the FDA has confirmed in a landmark update to its guidelines. It comes after the federal agency received reports from 359 women claiming a link between their implants and their diagnosis of anaplastic large cell lymphoma (ALCL), a rare form of non-Hodgkin's lymphoma.
As of February 1, 2017, nine of those women have died.
The update marks something of a triumph for US medical researchers, six years after the World Health Organization first warned of the potential link.
Last year French regulators became the first to acknowledge the 'clearly established link', ordering manufacturers to prove the safety of their products or face them being banned.
The UK Medicines and Healthcare Products Regulatory Agency is still analyzing the French and American reports, and has yet to acknowledge the 'clearly established link'.
Breast enhancements are the second most-popular form of plastic surgery in the US, with more than 300,000 procedures performed a year. Under scrutiny are implants with a textured surface – the most common type in the US, accounting for 99 percent of all used.
The regulators assured patients the cancer is easily treatable by removing the implants.
'All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants,' the FDA said in a statement released on Tuesday.
'Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation,' it said.
The agency said the update has come amid a recent surge in circumstantial evidence showing a link.
'As of February 1, 2017, the FDA has received a total of 359 medical device reports of breast-implant-associated ALCL, including nine deaths,' it said.
'Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells).
'There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants.'
Some research has suggested bacteria on the outer shell introduced during implantation leads to immune system changes that trigger the cancer. However, this is not proven.
British body the Medicines and Healthcare Products Regulatory Agency (MHRA) has not revised its guidance since 2014. A spokesman said: 'We will closely monitor the results of the investigation by the French Regulatory Authority and will take appropriate regulatory or safety action if needed.'
In most cases of BIA-ALCL, women are successfully treated with surgery alone, but chemotherapy and radiotherapy may also be needed.
There has been growing concern among the medical community about BIA-ALCL since 2011, when US health chiefs the Food and Drug Administration (FDA), the MHRA, and the World Health Organisation issued alerts to doctors and urged them to report cases.
Since then, doctors registered with the British Association of Aesthetic and Plastic Surgeons BAAPS, who represent all cosmetic surgeons working in the NHS, have warned patients of BIA-ALCL.