The US Food and Drug Administration (FDA) has provided an update on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). First, a bit of background: The FDA has been closely tracking the relationship between breast implants and ALCL since the agency first identified a possible association in 2011. Here’s what they have found:
As of 20 September 2017, the FDA has received a total of 414 medical device reposts of BIA-ALCL, including nine deaths.
- Of the 414 reports, 272 included information about the surface of the implant. There were 242 reports of implants with textured surfaces, and 30 implants with smooth surfaces. Of the 413 that reported implant fill types, 234 were silicone gel, and 179 saline.
- BIA-ALCL has been identified most often in patients undergoing implant revision operations for late-onset, persistent sermon. Half of the reported cases of BIA-ALCL were found within 7 to 8 years of implantation.
- Based on the clinical literature, the FDA estimates that the lifetime risk of developing BIA-ALCL for patients with textured breast Jim plants ranges from 1 in 3817 to 1 in 30,000.
So what does this all mean if you already have implants? You should continue to have routine care and support. As BIA-ALCL has generally only been identified among patients with late onset of symptoms (pain, lumps, swelling, breast asymmetry), removal of the implants if you do not have signs or symptoms is generally not recommended. And be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. As clinicians, we should consider the possibility of BIA-ALCL in a patient with late-onset, persistent seroma (a pocket of clear fluid) around the implant.
I’m Dr. Michael Hunter, and I encourage you to follow me on this blog, or on my wellness blog: Wellness!
I am a graduate of Harvard and Yale. I completed a radiation oncology training program at University of Pennsylvania, and practice in the Seattle area. Thank you for joining me today.
http://www.medscape.com (21 March 2018)