At the time, the FDA stated that, “All of the information to date suggests that women with breast implants have a very low but increased risk of developing anaplastic large-cell lymphoma compared to women who do not have breast implants.” ALCL, which can develop in areas of the body other than the breast, is quite rare: experts believe that it develops in just one of 500,000 women, and even less commonly in women with breast implants—annual diagnoses are estimated to occur in only 3 of 100 million women.
This week, the FDA updated its original warning regarding implants and ALCL, based on additional data provided by physicians. Although limited worldwide reporting prevents knowing the precise number of ALCL cases related to breast implants, as of February 1, 2017 the FDA had received 359 reports of implant-related ALCL, including 9 women who died from the disease. This new update reiterated that, although the risk for ALCL is greater for women who have breast implants than those who do not, it is still quite low.
The update included three new facts:
1. The risk of implant-related ALCL is higher in women
who have textured breast implants, compared to those
who have smooth implants.
Information about the type of breast implant involved
was available for 231 of 359 cases:
- 203 involved textured implants
- 28 involved smooth implants
of ALCL. Of 312 cases for which information was
- 186 were silicone gel implants
- 126 were saline implants
common in women who have implant revision
operations for late-onset, persistent seroma and who
experience related pain, lumps, swelling or asymmetry.
According to the FDA, “It is important to note that details on breast implant surface and fill type are limited. While the MDR [medical device report] system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data.”
ALCL can develop adjacent to or in the capsule of scar tissue surrounding the implant. Successful treatment most often involves removing the implant and the scar tissue; radiation therapy, chemotherapy or additional treatment is not usually required. The FDA recommends seeing a physician if the area around an implant looks or feels unusual.
FDA 2011 statement
FDA 2017 update