HomeBlogLatest News: FDA study documents low, but increased risk of ALCL with breast implants

Latest News: FDA study documents low, but increased risk of ALCL with breast implants

Update 08/07/19: To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market.

Update 04/30/19: FDA Updates ALCL Information; Cases Still Comparatively Rare

The FDA has found that women with breast implants may have a very low but increased risk of developing ALCL, a rare form of lymphoma, in the scar tissue and fluid adjacent to the implant.

The main symptom of ALCL in women with breast implants is a delayed fluid collection around the breast implant, presenting as significant swelling on the affected side. It is typically found many years after the implant surgery. It is most commonly associated with textured surface breast implants.

If you develop any unusual signs or symptoms any time after you have had breast implant surgery you should seek care from a Board Certified Plastic Surgeon. If diagnosed early, ALCL can usually be successfully treated by removal of the implant and surrounding scar tissue.

Background on ALCL

Anaplastic large cell lymphoma (ALCL) was first identified as a disease in 1985. It was found to be more common in young people, mostly males. It was initially identified in two distinct presentations, a cutaneous form defined by skin only involvement without systemic spread, and a second systemic presentation. Breast implant associated ALCL represents the third type of presentation.

In 2011, the FDA identified a possible association between breast implants and development of ALCL. Initially there were so few cases it was difficult to determine the disease entities and risk factors. Soon afterwards the American Society of Plastic Surgeons – the exclusive society of Board-Certified Plastic Surgeons – collaborated with the FDA to create the PROFILE registry to gather information and better characterize breast implant associated ALCL. In 2015 a landmark article appeared in the Plastic and Reconstructive Surgery Journal analyzing 173 cases worldwide. Since that time more articles have appeared and more emphasis has been placed on educating plastic surgeons about ALCL at national and industry meetings.

As of February 1, 2017 FDA has received 359 medical device reports of breast implant associated ALCL. There have been nine deaths. Of the 231 reports that include information on implant surface, 203 (87%) of these are reported to be textured surface implants. What is not clear from the FDA’s public website, but appears regularly in the plastic surgery literature, is whether these are unique cases or is there some duplication of cases. Mandatory reporting is provided by the manufacturers, but there are also voluntary reports submitted by surgeons and patients, both from the United States and abroad. Another problem has been simply a lack of information regarding the implants. The average time from implantation to diagnosis is eight or nine years and in at least one case was 40 years. After that length of time the information is simply no longer available.

It is estimated that 10 million women in the world have breast implants. Approximately 300,000 breast augmentations are performed in the United States annually, representing roughly 40% of the worldwide total. When considering these totals the incidence of ALCL is exceptionally rare, but because of its seriousness must be considered as a risk factor. The primary treatment is implant removal and removal of the scar tissue capsule around the implant. Some cases have been treated with radiation and chemotherapy.

All women should perform regular breast self-exams. Women with breast implants should include examination of the implant as part of that regular monthly exam. Any abnormal findings should be reported to your plastic surgeon.