More than 400 cases reported to FDA
The number of cases of a rare type of lymphoma linked to breast implants has surpassed 400, according to updated information from the FDA.
As of Sept. 30, 2017, the FDA had received 414 medical device reports (MDRs) of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), a 15% increase since agency's previous report on the issue in March 2017. The MDRs included nine patients who died.
Not all reports included complete information, but from the information available, the FDA determined that:
- 242 involved implants with textured surfaces and 30 with smooth surfaces
- 234 implants were filled with silicone gel and 179 with saline
- In about half the cases, the BIA-ALCL diagnosis occurred 7-8 years after implantation
As part of the update, the FDA reviewed reported cases of BIA-ALCL in the medical literature and found that the estimated lifetime risk of developing BIA-ALCL for a women with textured breast implants rages from 1 in 3,817 to 1 in 30,000. However, the FDA emphasized that it is not changing its recommendations on use of breast implants.