Breast Implant Removal & Downsizing

BIA-ALCL is not a form of breast cancer. Rather, it is a very rare and treatable T-cell lymphoma that forms in the capsule tissue that forms around all breast implants.

BIA-ALCL was first reported in the medical literature in 1997. The FDA made their first statement on a possible association between breast implants and ALCL in 2011. At the time, they estimated that the risk of a patient developing BIA-ALCL was less than one in 500,000. Since that time there has been an intense effort on gathering information about this new lymphoma. As of 2019 there were 573 cases reported worldwide, including 33 deaths. In the patients who did not survive, most experienced significant delay in diagnosis and did not have complete treatment. This is not uncommon during the early phase of a newly discovered disease when doctors don’t know to look for it and don’t have sufficient scientific evidence to know how to properly treat it.

Current estimates for the lifetime risk of getting ALCL range from 1/1000 to 1/30,000. As more information is gathered by the FDA we will have better risk estimates. The FDA reported that approximately 90% of cases were in patients with textured implants. Approximately 10% of patients had a smooth implant at the time of diagnosis, but limitation in available data makes it unclear how many of these patients had a history of having a textured implant previously. The FDA also reported that most cases of BIA-ALCA were associated with Allergan textured devices. There is currently not a single well-documented case involving a patient with a history of smooth implants only developing BIA-ALCL.

This lymphoma usually appears 7-8 years after placement of an implant. Patients with BIA-ALCL experience a new onset swelling of the effected breast. The swelling may increase over days to weeks, leading in some cases to one breast being twice the size of the other. The FDA recommends patients monitor their breast implants and contact their doctors immediately if they notice pain, swelling or any other changes in or around their implants. We encourage our patients to perform monthly self-exams and to follow up with us for an examination every year.

When a patient comes in with a fluid-filled breast a small needle will be used to withdraw some or all of the fluid to send for cytology. A pathologist will test the fluid for CD30 immunohistochemistry to identify whether features of ALCL are present. If the test is positive the patient will move on to treatment.

We recommend that patients should contact their plastic surgeon any time they notice a change in the way breasts look or feel after implant surgery. However, a breast cancer surgeon or oncologist can also evaluate new onset swelling. Whichever doctor gets involved first, one of the initial steps will be to refer you to a radiologist to perform a needle aspiration of the fluid. You will also likely be referred for breast imaging.

The current treatment guidelines call for en bloc removal of the implant and capsule. This means that the entire implant capsule is removed in one piece with the implant inside. The lymphoma cells are found in the scar capsule, so the entire capsule needs to be removed. Patients can decide whether or not they want to have a new implant placed after discussing the pros and cons with their surgeon and oncologist. The oncologist can also give recommendations regarding the possible need of radiation or chemotherapy based on the stage of the disease and how complete the resection was.

At present the FDA does not recommend patients with textured implants have them removed. The risk of developing BIA-ALCL ranges from 1/1000 to 1/30,000. To put this in perspective, a woman living in the United States has a 1 in 8 lifetime chance of developing breast cancer. Since the risk of getting BIA-ALCL is considered low, and there are potential (although uncommon) complications associated with implant removal surgery, the current suggestion is to leave textured implants in place. However, any patient who wants to discuss implant removal or have it performed is encouraged to call us so we can discuss the pros and cons of all options at length.