Over the last year, there has been significant concern by both patients and the media regarding the development of breast implant associated anaplastic large cell lymphoma. It’s created some anxiety and concern with patients who are considering breast implants for augmentation or reconstructive purposes. Hopefully by highlighting and reviewing the current literature and recommendations, we can provide some responsible and accurate information for patients with concerns.
Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a rare, T-cell lymphoma. It came to national attention only after the US FDA safety communication in 2011. Awareness has grown exponentially following advisory statements by the World Health Organization, the National Cancer Institute and the US FDA in 2016 in 2017.
In 2016, the National Comprehensive Cancer Network was established to set guidelines for BIA-ALCL. This network has established best-evidence guidelines for diagnosis and treatment. The following is a summary:
Approach to suspected BIA-ALCL patient
Any patient presenting with a seroma occurring greater than 1 year after implantation, not readily explained by infection, or trauma, should be considered suspicious for the disease. Postoperative seromas less than one year after first implant is not part of the disease spectrum of BIA-ALCL. Patient’s, only present with a rapid onset of spontaneous fluid collection, capsular mass at an average of 8-10 years after the original implantation was done with a textured breast implant. Reconstructive cases are roughly equal to cosmetic indications in the propensity for development of BIA-ALCL. All reported cases to date where a detailed implant history was available involved a textured surface breast implant.
Capsular contracture as an isolated finding has not manifested as BIA-ALCL.
Initial evaluation of an enlarged breast should include ultrasound evaluation for fluid collection, breast masses or enlarged lymph nodes. In cases where ultrasound does not adequately image the area, the patient may also require magnetic resonance imaging (MRI). Mammography has been found to be an inferior imaging technique for both the evaluation of effusion and mass.
In most cases, ultrasound was used as a screening tool. Any periprosthetic fluid collections should undergo fine-needle aspiration. At the time of aspiration, ultrasound guidance may aid in implant protection and displacement. The fluid aspirate should be sent to an experienced pathology department for evaluation for BIA-ALCL. A suspicious mass requires biopsy and evaluation to rule out breast cancer.
After the confirmation of BIA-ALCL, consultation with an oncologist and consideration for surgical oncologist are recommended. Additional screening tests, such as MRI or PET scan may be required for proper staging.
Early diagnosis and complete surgical excision of the disease, removal of the implants and the surrounding fibrous capsule is the optimal approach for the management of BIA-ALCL in the majority of patients. It is curative, if the disease has not spread past the capsule. At present, there is no indication for radical mastectomy, sentinel node biopsy or full axillary dissection. Surgeons and patients make consider removal of the contralateral implant because approximately 4.6% of cases have demonstrated incidental ALCL in the contralateral breast implant. Replacement with smooth implants can be done, depending on the patient’s desires, but the replacement with textured implants should be avoided because of the likely genetic predisposition and susceptibility of the patient.
In the rare case of advanced disease, chemotherapy will frequently be warranted. This occurs in 2–18% of patients with positive diagnosis of ALCL and is usually correlated with delayed diagnosis. Most insurance companies do not specify whether treatment for BIA-ALCL is a covered benefit, however, Blue Cross Blue Shield and Aetna have recently guaranteed coverage for implant and capsule removal with a confirmed diagnosis of BIA-ALCL in both cosmetic and reconstructive patients. The American Society of Plastic Surgeons and the National Comprehensive Cancer Network are working with insurance companies to establish coverage justification.
BIA-ALCL was first described over 20 years ago, but has recently led to significant concern among the public, media and surgeons. BIA-ALCL is a treatable, indolent disease with excellent prognosis in the majority of patients. Breast implants are considered safe and continue to be approved by the FDA for use in both cosmetic and reconstructive breast surgeries. Patient safety is my first and foremost responsibility, and as such, I happily share the newest information so that you can make an informed decision about proceeding with any implant related choices.
At my practice, we use a variety of different methods for breast augmentation and breast reconstruction, which include, smooth implants, saline implants, silicone implants and autologous fat grafting, all of which have not been correlated with the development of BIA-ALCL.
In the last year, I have received a few telephone calls from worried patients, regarding whether or not to remove their textured implants to avoid the development of BIA-ALCL. It is important to understand that it is a very rare disease, even in those patients with textured implants. The approximate rate is 1 case in every 30,000 patients with textured implants. In those patients who currently have textured implants, prophylactic removal is not indicated, because the risk of contracting ALCL is so low. I counsel patients to watch out for unexplained, unilateral breast swelling and ask them to call my office for an evaluation. Reassurance, assessment and diminishing anxiety is part of what will be performed on that initial evaluation. Even if the patient presents with unilateral breast swelling and is atleast one year out after surgery, the likelihood that it is ALCL is less than 10%. So, if you develop unilateral breast swelling, take a deep breath, call your surgeon and get evaluated. The likelihood is that you do not have BIA-ALCL.
Please don’t hesitate to contact us via the practice website or call (415) 668-2122 with any questions regarding your particular breast concerns. I hope this article was useful, and I wish you health and prosperity.