BIA-ALCL For Patients with Breast Implants

WHAT IS BIA-ALCL?

BIA-ALCL is Breast Implant-Associated Anaplastic Large Cell Lymphoma, a T-cell lymphoma that can arise around breast implants placed for either reconstructive or cosmetic indications.1 Currently, the cause of BIA-ALCL is not clearly understood, but has only been associated with textured implants. It is believed that the rough surface on a textured implant, may cause a chronic immune reaction, leading to the infiltration and proliferation of lymphocytes. ALCL has NOT BEEN ASSOCIATED with SMOOTH SHELL IMPLANTS. Dr. Mulholland has been using, almost exclusively, only smooth-shelled implants for the past 10 years.

 

If I UNDERGO A SMOOTH SHELL, COHESIVE GEL BREAST AUGMENTATION, DO I NEED TO WORRY ABOUT ALCL?

BIA-ALCL has not been associated with smooth shell breast implants and is the only type of implant that Dr. Mulholland offers.

 

IS BIA-ALCL A TYPE OF BREAST CANCER?

BIA-ALCL is not a cancer of the breast tissue itself, but a type of cancer that develops around the scar tissue from the implant called the capsule, and in some cases, can spread throughout the body.1

 

IS BIA-ALCL COMMON?

It is estimated that there are 35 million women worldwide who have breast implants.2 The true incidence of BIA-ALCL is hard to estimate.3 To date, the estimated incidence rates in the scientific literature range from 0.03% to 0.003%, or 1 in 3,817 to 1 in 30,000.4-7*

* Publications referenced here include patient populations with breast implants and patients specifically with textured breast implants.

 

THE INCIDENCE OF BREAST CANCER IN CANADA IS 1 IN 8.

It is estimated that 1 in 8 Canadian women will develop breast cancer. This must remain the #1 health focus for women, as breast cancer can be cured with early detection. Follow the Canadian Cancer Society recommendations for breast cancer screening and early detection as, even with ALCL and textured implants, breast cancer remains the most significant risk to a women’s health.

 

WHAT CAUSES BIA-ALCL?

International health regulatory agencies are proactively working with implant manufacturers to study BIA-ALCL.8-12 To date, rough implant texture, genetics, and bacteria have been implicated and are undergoing further study.1

 

WHAT ARE THE SYMPTOMS OF BIA -ALCL?

BIA-ALCL is most commonly reported at an average of 8–10 years following implant placement.13 The first symptoms are usually a swelling of the breast—often caused by fluid building up around the implant.1 Other symptoms can include pain, lumps, sudden hardening and unevenness between breasts.1

 

IS BIA-ALCL TREATABLE?

Yes. When diagnosed early by a surgical specialist, BIA-ALCL can be treated, often successfully.1 In most cases, BIA-ALCL can be treated by removing the breast implant and the surrounding scar capsule. This procedure is called an En Bloc resection, as it is vital that the entire capsule around the implant and the implant itself be removed without leaving any of the capsule behind. An En Bloc resection of the capsule and implant is a significant surgical procedure with significant risks.

Dr. Mulholland is a trained Head and Neck Oncologic surgeon and for many years has performed complex En Bloc resections of tumors of the head and neck. If you elect to undergo this procedure, Dr. Mulholland will review the risks and benefits with you. Patients who remove their textured implants and the capsule either replace them with a smooth shell implant, undergo fat grafting to the breast, or have no aesthetic reconstruction at all.

After the En Bloc resection, the breast capsule is analyzed for ALCL and, in the vast majority of cases, no ALCL will be found. If ALCL is discovered, additional treatment may be necessary depending on the individual.1 In instances where the disease has spread throughout the body, rare cases of death have been reported.1.14

 

WHAT TYPES OF IMPLANTS ARE ASSOCIATED WITH BIA-ALCL?

BIA-ALCL has NOT BEEN ASSOCIATED WITH SMOOTH SHELL GEL OR SALINE  IMPLANTS.  However, ALCL has been associated with both textured saline and silicone implants, round and anatomic implants, all gel types, all projections, as well as textured implants for both reconstructive and cosmetic purposes.1

 

WHAT ARE TEXTURED IMPLANTS AND HOW DO THEY AFFECT MY RISK OF DEVELOPING BIA-ALCL?

Breast implants have different surface textures, including smooth or textured. For cases reported to date, BIA-ALCL has only been found in patients with textured implants1. However, the risk of developing BIA-ALCL with textured implants is low.6 Although it is difficult to quantify the actual incidence and prevalence of BIA-ALCL3, to date the estimated incidence rates range from 0.03% to 0.003%, or 1 in 3,817 to 1 in 30,000.4-7

* Publications referenced here include patient populations with breast implants and patients specifically with textured breast implants.

 

SHOULD MY SURGEON STILL CONSIDER A TEXTURED IMPLANT?

Surgeons have different reasons for selecting a textured implant. Some implant types, such as anatomically shaped implants, are only available with a textured surface.15 Make sure to discuss the various options with your surgeon, as every woman’s body is different.

Dr. Mulholland has, almost exclusively, offered only smooth-shelled, cohesive gel implants since they became available in 2010 and are the only type of breast implant he offers.

 

WHAT DO INTERNATIONAL HEALTH REGULATORY AGENCIES HAVE TO SAY ABOUT TEXTURED IMPLANTS?

For patients who currently have implants and are not experiencing any problems or symptoms, international health regulatory agencies (i.e., United States Food and Drug Administration [FDA], Health Canada, United Kingdom Medicines and Healthcare Products Regulatory Agency [MHRA], France’s Agence Nationale de Sécurité du Médicament [ANSM], and Australia’s Therapeutic Goods Administration [TGA]) do not recommend removal of textured implants or any changes to their routine medical care.

However, if you have had asymptomatic textured gel or saline implants for the past 10 years or more, for preventative reasons or general reasons of well-being, you may elect to have them removed together with the capsule and possibly replaced with smooth shell cohesive gel implants, fat grafting or no aesthetic breast enhancement at all.

On April 4th, 2019, Health Canada announced that they were going to suspend the sale of   Allergan’s Textured Biocell implant. Of course, the smooth shell, cohesive gel, and Naturelle implants will still be available.

 

IF I ALREADY HAVE TEXTURED IMPLANTS, WITH OR WITHOUT SYMPTOMS, WHAT SHOULD I DO?

If you have textured shell implants and do not have any symptoms (see above), then the recommendation is to monitor your implants every year with an ultrasound or MRI and follow the Canadian Cancer Society’s recommendation on surveillance.

If you have hardening of one, or both of your implants, along with other symptoms, Dr. Mulholland will recommend a breast ultrasound and mammogram. He will then meet with you to discuss the risks, benefits and recovery of an En Bloc resection of the capsule and implant, and the replacement options (smooth shell implants and/or fat grafting or nothing).

Dr. Mulholland will perform the En Bloc resection and removal of the textured implants, which is a 2.5 hour outpatient surgery, with or without smooth shell implant replacement. There will be a surgical fee for this procedure, and the capsular tissue will be sent off for careful histological analysis.

It is probable the results of your capsular tissue will be normal with no evidence of ALCL detected. In this case, you have successfully treated a routine capsular contracture (2%-5% of all implant patients develop this and it is NOT ALCL) and if you opted for it, you now have smooth shell implants and need not worry about ALCL.

If the pathological analysis comes back confirming ALCL (note that Dr. Mulholland has not had such a patient to date), then you will be referred to an oncologist to determine if adjuvant or adjunctive treatment is recommended following En Bloc removal of the capsule and implant.

 

WHO PAYS FOR THIS EN BLOC PROCEDURE, IMPLANT REMOVAL AND POSSIBLE REIMPLANTATION?

A patient with symptomatic textured implants, will most commonly have benign capsular contractures with no ALCL. There is a surgical fee for the En Bloc resection procedure, with or without smooth shell breast augment re-implantation. If the capsular tissue comes back with a diagnosis of ALCL after being sent off for careful histological analysis, Dr. Mulholland and his team at SpaMedica will petition on your behalf to receive some compensation from the manufacturer.

 

WHAT IS ALLERGAN DOING ABOUT BIA-ALCL?

The manufacturer of the cohesive gel implants, Allergan, does provide rare-event coverage, up to $5,000 USD for its products in cases of BIA-ALCL. Patients with Allergan implants are eligible for assistance with out-of-pocket surgical costs, not covered by insurance, including removal of the breast implant(s) and associated tissue.

 

WHO SHOULD I CONTACT IF I HAVE MORE QUESTIONS OR CONCERNS?

If you are an existing patient of Dr. Mulholland, and underwent breast augmentation surgery between 1997-2010, you will have textured saline or gel implants (the only available option at the time). Call the office at 416-922-3743 and speak with Dr. Mulholland’s Senior Surgical Coordinator, Audrey Kaufman. Audrey will personally assist you through your implant management decision process and guide you on how to treat or manage symptomatic or asymptomatic textured breast implants.

 

Contact with Message

Reference

1. Clemens MW, Nava MB, Rocco N, Miranda RN. Understanding rare adverse sequelae of breast implants: anaplastic large-cell lymphoma, late seromas, and double capsules.      Gland Surg. 2017;6(2):169-84.2. Sieber DA, Adams WP, Jr. What’s Your Micromort? A Patient-Oriented Analysis of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Aesthet Surg J. 2017;37(8):887-91. 3. Shahriari N, Ferenczi K, Heald PW. Breast implant-associated anaplastic large cell lymphoma: A review and assessment of cutaneous manifestations. Int J Womens Dermatol. 2017;3(3):140-4. 4. Campanale A, Boldrini R, Marletta M. 22 Cases of Breast Implant-Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health. Plast Reconstr Surg. 2018;141(1):11e-9e. 5. de Boer M, Dan Der Hulst R, Van Leeuwen F, de Jong D, Rakhorst H, editors. Breast-implant associated anaplastic large cell lymphoma (BIA-ALCL): Relative and absolute risk assessment based on 100% of all national cases of BIA-ALCL in the Netherlands. 28th EURAPS Annual Meeting; 2017; Pisa, Italy. 6. Doren EL, Miranda RN, Selber JC, Garvey PB, Liu J, Medeiros LJ, et al. U.S. Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Plast Reconstr Surg. 2017;139(5):1042-50 7. Loch-Wilkinson A, Beath KJ, Knight RJW, Wessels WLF, Magnusson M, Papadopoulos T, et al. Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk. Plast Reconstr Surg. 2017;140(4):645-54. 8. U.S. Food and Drug Administration. Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) 2018 [last accessed 2018 January 22]. Available from: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995. 9. Health Canada. Summary Safety Review – Breast Implants – Assessing the potential risk of cancer (Breast implant associated-anaplastic large cell lymphoma) 2017 [last accessed 2018 January 22]. Available from: https://www.canada.ca/en/health-canada/services/ drugs-health-products/medeffect-canada/safety-reviews/breast-implants-assessing-potential-risk-cancer.html. 10. U.K. Medicines and Healthcare Products Regulatory Agency. Breast implants and Anaplastic Large Cell Lymphoma (ALCL) 2017 [last accessed 2018 January 22]. Available from: https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl. 11. Australian Therapeutic Goods Administration. Update – additional confirmed cases of anaplastic large cell lymphoma 2017 [last accessed 2018 January 22]. Available from: https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma#reduce-risk.12. ANSM. Lymphome Anaplasique à Grandes Cellules associé aux implants mammaires (LAGC-AIM): Point sur les investigations en cours – Point d’Information 2016 [last accessed 2018 January 22]. Available from: http://ansm.sante.fr/S-informer/Points-d-information-Points-d-information/Lymphome-Anaplasique-a-Grandes-Cellules-associe-aux-implants-mammaires-LAGC-AIM-Point-sur-les-investigations-en-cours-Point-d- Information. 13. Clemens MW, Horwitz SM. NCCN consensus guidelines for the diagnosis and management of breast implant-associated anaplastic large cell lymphoma. Aesthet Surg J. 2017;37(3):285-9. 14. Clemens MW. Reply: Global Adverse Event Reports of Breast Implant-Associated ALCL: An International Review of 40 Government Authority Databases. Plast Reconstr Surg. 2018;141(1):179e-80e. 15. Nahabedian MY. Shaped versus round implants for breast reconstruction: indications and outcomes. Aesthet Surg J. 2014;2(3):e116.