The U.S. Food and Drug Administration says it has received reports of 9 deaths and more than 350 cases of a rare blood cancer linked to breast implants.
The FDA said it now agrees with the World Health Organization, which concluded years ago this type of lymphoma can develop following breasts implants.
Concerns were first raised at the FDA in 2011, but the agency said then that there were too few cases to know if there was a connection.
The disease seems to occur more often with textured implants in the scar tissue near the implant and is associated with pain and swelling sometimes years after the surgery has healed.
Whether the implants contained silicone gel or saline appeared much less important than surface texture in disease risk.
The FDA said Tuesday it can’t determine how many cases there are, but noted Australia has also reported three deaths.
Details on breast implant surface and fill type are limited, the U.S. regulator said.
Since the blood cancer has generally been identified only in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, preventative “breast implant removal in patients without symptoms or other abnormality is not recommended,” the FDA said.
In most cases, it’s treatable, The New York Times reported.
Health Canada’s website also notes breast implants have been associated with this form of lymphoma, known as anaplastic large cell lymphoma.
The FDA said it’s difficult to give an exact number of cases because of a lack of world-wide reporting and global implant sales data.