What you need to know about ALCL

 

When you had your implants placed, you may have been given a small wallet-sized card with the make and model of implant.

For any patient that had their implants placed at Maxwell Aesthetics within 10 years, we have the records of all breast implants place on file. If you had your implants placed greater than 10 years ago, we still may have your record. Please call us so we can let you know what type of implant you have. If you did not have your implants placed at Maxwell Aesthetics, you should contact your surgeon or hospital/surgery center where your implants were placed and ask for your operative report. Usually, there is a medical records office or administrator who will be able to retrieve the report.

Textured Allergan implants affected by the FDA statement are all from Allergan include;: Natrelle Saline-Filled breast implants

Natrelle Silicone-Filled breast implants Natrelle lnspira Silicone-Filled breast implants

Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants

What symptoms are seen with BIA-ALCL?

 The most common symptom is breast swelling that occurs after one year post textured implant placement. It may or may not cause pain. The average time for the swelling to occur in patients who have BIA-ALCL is 8 years after placement. Other symptoms that can occur include a lump found in the breast or in a lymph node in the armpit. While swelling or lumps should prompt a medical evaluation, this does not always indicate BIA-ALCL. There may be other benign reasons for these symptoms.

How do we test for BIA-ALCL?

If you have textured implants, the FDA recommends routine medical care and follow up including mammography when appropriate. If you have any swelling in the breast or lumps in the breast or armpit, please contact our office for an evaluation to determine if you should have an ultrasound imaging exam performed. Currently, there are no screening recommendations for patients with textured implants without symptoms.

If you have swelling and there is fluid around your implant seen on an  ultrasound,  a  sample  of the fluid can be collected with a small needle and sent for a special BIA-ALCL pathology assessment. We know there are specific markers on BIA-ALCL cells called CD30 that can be tested to make a diagnosis. iv

What if I have textured implants but do not have any symptoms? Should I have my implants removed?

Currently, the FDA does not recommend removing textured implants in patients without symptoms. While this is a broad statement, it is my opinion that each patient should be assessed and have a treatment plan for their individual medical care. There are several factors including capsular contracture (firmness around the implant), peace of mind or other reasons that removing textured implants may be the best option for you. If you feel this may be your situation or if you have any questions to better help you make an informed decision, please schedule a consultation with Dr. Kaminsky.

What is safe if I remove my implants? Can I have an additional non-textured implant? Am I a good fit for a breast lift?

Briefly, yes – other non-textured implants can be placed (gel or saline) and a breast lift may be a good option as well. Each patient will have a variety of factors to consider in order to individualize their best treatment plan.

I just received a BIA-ALCL diagnosis from a sample of fluid that was taken from my breast, now what?!?

The first step is to remember to breathe! There will be a lot of information to process and it can be overwhelming. Some positive news is that BIA-ALCL is a very slow cancer. There have only been 12 reported deaths in patients with BIA-ALCL from the 573 cases in the United States. It is curable.

Schedule an appointment immediately with Dr. Maxwell and let our scheduler know you have a confirmed diagnosis. We encourage you to keep a journal/diary and write down all of your questions as there will be many. It can be very challenging to recall important questions you have while meeting with your surgeon or other physicians.  It is also very important to have a family member or close friend join you at appointments for both support as well as helping remember and process all of the details of your treatment plan.

Patients with a diagnosis of BIA-ALCL that is limited to the capsule surrounding the implant and does not go beyond this boundary (the majority of new diagnoses) can be cured with a total capsulectomy and removal of the implant. Dr. Maxwell has a tremendous amount of experience with the total capsulectomy and implant removal procedure and has pioneered surgical techniques to ensure removal of the complete capsule in even the most difficult cases.

Chemotherapy is not needed unless there is very rare, advanced disease that is well beyond the existing capsule surrounding the implant into the lymph nodes or far from the breast.

I like to be a well-informed patient, what are some reliable resources you recommend?

 While there is a lot of misinformation on the internet, there are also excellent sources that can provide additional accurate and up to date information.

One such site, which is maintained by the American Society of Plastic Surgery:

www.plasticsurgery.org/patient-safety/breast-implant-safety/bia-alcl-summary

An additional website that can help answer some of the questions regarding the Allergan textured implant warranty:

www.allergan.com/biocellresources

While this is a lengthy post, there is a lot of information to review. If you have any questions, points of clarification, or would like to be evaluated, please call Maxwell Aesthetics for a consultation at 520-751- 1225. If you have found this Q&A to be helpful, please share it. It is important that accurate

information is shared to help those affected by the textured implant recall and raise BIA-ALCL awareness.


www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-brea_st­ implants-requests-allergan

ii https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allergan-pdf-documents/biocell­ replacement-warranty.pdfi

iii www.fda.gov/medicaI-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic­ large-cell-lymphoma

iv Current Risk Estimate of Breast Implant Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants.

Collett DJ, Rakhorst H, Lennox P, Magnusson M, Cooter R, Deva AK. Plast Reconstr Surg. 2019 Mar;143:30S-40S

v Breast implant-associated anaplastic large cell lymphoma, a systematic review and in-depth evaluation of the current understanding. Ebner PJ, Liu A, Gould DJ, Patel KM. J Surg Oncol. 2019 Aug 1

vi The Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand Confirms the Highest Risk for Grade 4 Surface Breast Implants. Magnusson M, Beath K, Cooter R, Locke M, Prince HM, Elder E, Deva AK. Plast Reconstr Surg. 2019 May;143(5):1285-1292

vii ASPS and ASAPS BIA-ALCL Advisory Update www.surgery.org/sites/default/files/BIA-7-31-18.pdf