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Breast Implant Resources

The Aesthetic Society has a number of resources to help you and your patients navigate the latest findings on BIA-ALCL and Breast Implant Illness (BII).  They are detailed below:

Breast Implant Illness

Breast Implant Illness (BII) has become a hot-button issue as of late, both in the media and as reported by many of our members based on what they’re seeing in their practices.

Unlike BIA-ALCL, a scientifically-known condition linked to implants, Breast Implant Illness (BII) falls into a gray area, as there is no science behind it yet to either confirm or deny its existence. As such, we hope to support our members as advocates for their patients by providing useful materials including the talking points below as research into Breast Implant Illness (BII) continues.

Written and clinical resources:

Breast Implant-Associated ALCL

ASAPS is committed to patient safety, advancing the quality of care, and practicing medicine based upon the best available scientific evidence on breast implants.

Written and Clinical Resources:

Video Resources:

Q&A

Allergan announced a voluntary recall of Biocell implants on July 24, 2019. What does that mean? Why would they use a word that could cause such anxiety for our patients?

  • Recall is a regulatory term used when a manufacturer takes corrective or removal action to address a problem with a medical device that violates FDA regulations. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.[10]
  • This recall involved a voluntary suspension of sales, shipments, and removal of devices from operating rooms and physician offices.
  • This does not mean Biocell implants that are already implanted should be removed.

Has there been a case of ALCL in a patient who had implant removal without capsulectomy?

  • There have been cases where ALCL was diagnosed after implant removal without capsulectomy. Since all cases had a history of seroma at the time of implant removal, which had not been tested for ALCL, it is felt that these cases were undiagnosed ALCL at the time of implant removal.[8]
  • All ALCL cases that have been reported where a smooth implant was in place at the time of diagnosis had a previous history of a textured implant, mixed implant history, or unknown implant history. The details of those cases are unclear as to whether a capsulectomy was or was not performed. For that reason, removal of the capsule should be considered if it can be safely performed to potentially lower the risk of developing BIA-ALCL.[9]

If capsulectomy is performed should the capsule be sent to pathology? What testing should be performed? Is CD30 testing necessary?

  • Any capsule which is removed, especially if it is in any way abnormal, should be sent to pathology for microscopic evaluation with further testing as indicated. Expert pathologists do not believe that in the absence of suspicious morphology, CD30 stain is needed for examination of a capsule. (personal communication, Dr. Marshall Kadin, April 24, 2019). There has been a social spread of misinformation recommending sending the solid capsule for CD30.[6] The solid tissue pathologic evaluation is the only test needed after capsulectomy unless abnormalities are found, then further testing will be considered per the pathologist’s recommendations.[3] CD30 is a normal cell marker, not specifically related to BIA- ALCL. There can be CD30 positive lymphocytes in a normal lymphocyte population. CD30 markers are significant when found in abnormal lymphocytes, and specifically with a single clone of CD30+ ALK- anaplastic lymphocytes.[7] We recommend for any concerns, consultation with the pathologist be considered prior to surgery.
  • Capsule tissue should be sent in formalin unless the pathologist will be performing cultures of the tissue or if the pathologist requests a fresh specific after preoperative consultation
  • Any seroma fluid should be sent for cytology and immunohistochemistry for CD30 testing
  • For implants placed for cosmetic reasons, insurance may not cover exam by a pathologist, so informed financial consent for testing should be obtained preoperatively.

Should acellular dermal matrix (ADM)/mesh be removed if a capsulectomy is being performed in an asymptomatic patient?

  • ADM or mesh that was placed at previous surgery should only be removed if it is not incorporated or as part of an en bloc capsulectomy where tissue and implant are removed together in to obtain clear margins for ALCL or other malignancy as indicated.[3]

Has there been a case of ALCL in a patient who had an uncomplicated textured expander to smooth implant?

  • Anecdotally, we are aware of a case, but this is yet to be confirmed and/or published.

Should a capsulectomy be performed at the time of exchange from textured expander to smooth implant?

  • In the absence of seroma, mass in the capsule, or any other abnormality encountered, removal of the capsule is not necessary unless clinically indicated.

If an asymptomatic patient does elect to have their implants removed/replaced is a total or partial capsulectomy required?

  • There is no scientific data to support complete removal of an implant capsule in the absence of malignancy or capsular contracture.[4]
  • If a capsulectomy is performed, both solid tissue and any seroma fluid (if present) should be sent for pathological examination whenever exchange or removal is performed for any indication.[3]
  • Capsulectomy carries risk(s) and informed, educated consent should be obtained after discussing the potential risks with the patient.[4]
  • For patients who elect to undergo textured implant removal, with or without replacement, because of anxiety related to their textured implant and potential for development of ALCL, the aim is to perform a precise complete or partial capsulectomy unless intraoperative findings do not allow this to be performed safely.[5]
  • The capsule should be photographed to document its appearance, and the capsule sent to pathology for examination with cultures performed if indicated or requested by the patient.
  • Any patient with symptoms, swelling, seroma, mass, rash, etc. should have appropriate preoperative work-up with aspiration of fluid, cytology, immunohistochemistry testing for CD30, and cultures as indicated per NCCN guidelines for diagnosis of BIA-ALCL.[3]

Should asymptomatic patients have their implants removed prophylactically?

  • None of the regulators worldwide are recommending prophylactic removal. The FDA has specifically stated “If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL.”[1]
  • For patients who are concerned, evaluate the patient for signs/symptoms of ALCL and test appropriately as indicated.[2]
  • If the patient is asymptomatic, offer to see the patient for regular follow up with exam and imaging as indicated.

How do you manage an asymptomatic patient with a textured implant who is concerned about developing ALCL?

  • Patients need to be evaluated for a history of any change to her breast, specifically those related to ALCL, swelling, mass, pain, or rash. Any symptoms need to be evaluated with physical examination, ultrasound, mammogram, or MRI as indicated.[2]
  • If the physical examination and testing are negative, the patient should be reassured that nothing has been found physically or radiologically to indicate BIA-ALCL. These patients should be offered regular follow up visits and educated on the signs/symptoms of ALCL and instructed to return sooner for any change in their breast.

Source: McGuire et al in ASJ Open Forum: “Management of Asymptomatic Patients With Textured Surface Breast Implants”

REFERENCES
1. The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication. https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue. Accessed August 1, 2019.
2. Magnusson M, Beath K, Cooter R, et al. 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. Plast Reconstr Surg. 2019;143(5):1285-1292.
3. Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthet Surg J. 2019;39(Supplement_1):S3-S13.
4. Lapid O, Noels EC, Meijer SL. Pathologic findings in primary capsulectomy specimens: analysis of 2531 patients. Aesthet Surg J. 2014;34(5):714-8.
5. McGuire PA, Haws MJ, Nahai F. Breast implant illness: how can we help? Aesthet Surg J. 2019;39(11):1260-1263.
6. Magnusson MR, Cooter RD, Rakhorst H, McGuire PA, Adams WP Jr, Deva AK. Breast implant illness: a way forward. Plast Reconstr Surg. 2019;143(3S A Review of Breast Implant- Associated Anaplastic Large Cell Lymphoma):74S-81S.
7. Kadin ME, Morgan J, Xu H, Glicksman CA. CD30+ T cells in late seroma may not be diagnostic of breast implant-associated anaplastic large cell lymphoma. Aesthet Surg J. 2017;37(7):771-775.
8. Chacko A, Lloyd T. Breast implant-associated anaplastic large cell lymphoma: a pictorial review. Insights Imaging. 2018;9(5):683-686.
9. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma. Accessed August 1, 2019.
10. FDA 101: Product Recalls. https://www.fda.gov/consumers/consumer-updates/fda-101-product-recalls. Accessed August 1, 2019