July 26, 2019 Important letter from Dr. Gayoso to his patient with textured implants:
I am directing this brief letter to my patients who have textured surface breast implants as part of an effort to keep you informed and to reassure you that I am committed to your care over time. I am as ever available to you by phone or in person.
As we all have become aware, there is concern about the possibility of developing a tumor in the scar tissue around a breast implant. It is called BIA-ALCL (breast implant associated anaplastic large cell lymphoma). This is very uncommon. Women with this tumor tend to develop enlargement or change in shape of one breast, or pain, or possibly a lump in the breast or the arm pit. Generally, this would happen several years after the implant is placed. It is curable with removal of the implant and the capsule (i.e. the scar tissue), but without treatment the tumor could grow and spread. There have been deaths related to BIA-ALCL.
It seems that BIA-ALCL is associated with the texturing that is used in the surface of certain types of implants. This includes the texturing on Allergan style 410 teardrop shaped implants, and the textured round implants from Allergan. It does not seem to be related to whether an implant is saline or silicone filled. Smooth surface implants do not seem to be linked to BIA-ALCL.
The FDA has recommended that women with textured surface implant be aware of the possibility, and monitor their breasts for changes in size, shape, and appearance; but they have NOT recommended removal of these implants in patients who do not have signs or symptoms of a problem. The American Society of plastic surgeons, and the American Society for Aesthetic Plastic Surgery concur with this recommendation. This is because the tumor is very uncommon. While it is possible to remove and replace these implants, it may be that the risks of another surgery are greater than the risk developing ALCL.
Recently the FDA recommended that Allergan voluntarily recall all unused textured surface implants, and this is widely reported. It does NOT mean a recall of implants already in place, and it does not mean they are recommending removal.
Since surveillance and observation over time are so important, I will want to evaluate you in person, and discuss in an individual and detailed manner your concerns and develop a plan for you. This a process we are starting now. I and my clinical staff will also be calling all our textured surface implant patients in the coming days.
While this letter contains limited information, there is an excellent article at the website of the FDA regarding BIA-ALCL. https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan. There are also similar summaries at The American Society for Aesthetic Plastic Surgery https://aestheticsociety.cmail19.com/t/r-l-jiulyhg-uhthdhkkkt-j/ , and The American Society of Plastic Surgeons http://email.plasticsurgery.org/c/1XNSuR79dMyJNTQdFQIO2B1KTGi .
Please be assured of my commitment to you and our long-term relationship.
Antonio J Gayoso, MD