Breast Implant Associated Anaplastic Large Cell Lymphoma & Breast Implant Illness
By Inessa Shlifer, PA-C, DFAAPA
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
An alarming number of women with textured breast implants have developed Anaplastic Large Cell Lymphoma (ALCL).
These textured implants gained their popularity because they tend to adhere to surrounding tissue providing a stable implant position. In many cases, especially those combined with mastopexy (breast lift), achieving stability is important.
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Breast Augmentation & Anaplastic Large Cell Lymphoma
Breast augmentation (BA) is not only used for aesthetic enhancement. Surgical teams widely offer the option to women with BRCA1 and BRCA2 gene mutations who undergo prophylactic double mastectomy followed by bilateral breast implants.
None of the following complications associated with smooth gel breast implants manufactured by Mentor or Allergan exist in the literature. Contrary the Allergan Natrelle® saline-filled breast implants, the Natrelle® silicone-filled textured breast implants are associated with anaplastic large cell lymphoma.
History of Breast Implants
- 1976: After the U.S. Congress passed the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the FDA started regulating breast implants as a medical device.
- 1991: FDA starts to regulate silicone gel-filled breast implants. The agency required manufacturers to prove safety and efficacy but allowed them to keep their products on the market until they provided such data.
- 1992: FDA issues moratorium to stop using silicone gel-filled breast implants until manufactures provided safety and efficacy data.
- April 1992: The FDA allows breast implants to be used for breast reconstruction only. They also recommended researchers follow patients in ongoing clinical studies.
- March-May 2000: The first saline-filled breast implants earn approval for reconstruction and cosmetic use.
- August 2000: FDA approves silicone gel-filled breast implants manufactured by Mentor.
- October 2003: FDA approves silicone gel-filled implants manufactured by Allergan.
- November 2006: Both Mentor and Allergan get a green light for their silicone gel-filled breast implants since their ban in 1992.
- January 2011: FDA issues a warning about anaplastic large cell lymphoma associated with textured silicone gel-filled breast implants.
In 1992, silicone gel-filled breast implants were taken off the market on a notion they had high rapture rates and caused cancer and other inflammatory diseases. It took almost ten years for manufacturers to convince regulators they had developed new, safer devices.
In 2006, they re-appeared on the market with the requirement that both breast implant manufacturing giants – Mentor and Allergan – would perform 10-year follow up on 40,000 patients.
In January 2011, the FDA issued a warning about ALCL associated with textured silicone gel-filled breast implants.
At the time of publication, there is a Class I recall (the most serious type) as identified by the FDA of Allergan Natrelle Biocell Textured Breast Implants due to the risk of BIA-ALCL.
Anaplastic Large Cell Lymphoma (ALCL)
Anaplastic Large Cell Lymphoma is a form of cancer that seems to be confined to breast implants surrounding tissue capsule. Upon explantation of textured breast implants, there is often fluid inside of the capsule and sometimes the capsule itself appears to be thicker than a normal capsule.
Patients that seek removal of breast implants present with concerns of painful sensations in breast tissue and armpit as well as redness of the surrounding skin.
ALCL is not a true breast cancer. It’s a very slow moving form of cancer of the immune system that takes 2 to 10 years to develop. It can be cleared by removing the breast implants and surrounding breast capsule.
The common symptoms related to ALCL are breast asymmetry, redness, breast hardening, and painful lumps in the breast tissue.
Other Risks with Breast Implants
At the annual New York Regional Society of Plastic Surgeons (NYRSPS) conference on October 26th, 2019, plastic surgeons held a special panel of experts discussing this same topic – Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) – and one more that is being widely covered in the news and on social media – Breast Implant Illness (BII).
Breast Implant Illness
BII is a condition where breast implants provoke a host of autoimmune reactions and diseases, such as rheumatoid arthritis, scleroderma, Sjogrens’s syndrome, and sarcoidosis. Even though no hard scientific evidence exists to support the existence of BII, the level of concern is increasing and cannot be ignored. Women worldwide present with symptoms that stand in the way of their healthy lifestyle.
At the conference, we had heated discussions about the credibility of such symptoms and what regulatory mechanism should be implemented to follow these developments.
Patricia A. McGuire, MD, a board-certified plastic surgeon on the task force for the American Society for Aesthetic Plastic Surgery was one of the presenters on BII. She believes that despite not having identifiable evidence for BII, this condition needs further investigation and should be taken seriously.
What We Are Doing
In both offices where I work as a plastic surgery PA, we have placed a good number of textured breast implants. Today with the ALCL scare, our patients call us and ask if they should come to the office and either remove the textured implants or replace them with smooth breast implants. The US Food and Drug Administration (FDA) doesn't currently require the removal of textured implants unless patients develop signs or symptoms of BIA-ALCL.
However, our patients are often too anxious to wait for this and we recommend they come in for replacement. As a standard surgical procedure, we remove the implants, perform a total capsulectomy (complete removal of the capsule), irrigate with triple antibiotic, and replace with smooth silicone-filled implants. We send specimens for pathology examination. So far, we have not had any cases of BIA-ALCL; however, when patients desire to exchange implants, it is our obligation to do so.
Plastic Surgery CME
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