Mark Clements MD Plastic Surgery- Associate professor – The University of Texas

MD Anderson Cancer Center- multidisc team

Roberto Miranda, MD Hematopathology

Kelly Hunt, MD Breast Surgical Oncology

Swaminathan Iyer, MD Lymphoma Oncology

Wei Yang, MD Breast Diagnostic Radiology

Gregg Staerkal, MD Cytopathology

 

Endorsers

 

AAPS / FILACP / EASAPS / ASPS / ICOPLAST / AICPE / SICPRE / EURAPS/ E.S.P.R.A.S

1997 John Keech, DO Oncologist and Brevator Creech, MD Plastic Surgeon discovered the first case of BIA-ALCL

(1997 – Pioneers of Breast Implant-Associated Anaplastic Large Cell Lymphoma: History from case report to global recognition )

 

Breast Implant Associated Anaplastic Large Cell Lymphoma

FDA – BIA-ALCL Update

 

573 Unique and Pathologically Confirmed BIA-ALCL Cases Worldwide

Deaths 33 Worldwide (12 US)

660 MDRs March 2019

414 MDRs March 2018

359 MDRs March 2017

258 MDRs January 2016

64 MDRs January 2011

 

BIA-ALCL Global Network Roundtable

 

33 countries / updated October 2019

Abbreviations

c – cases   d – death(s)

• Argentina 8c / 1 d
• Australia 109c / 4 d
• Belgium 12c
• Brazil 12c / 1d
• Canada 31c / 1d
• Chile 2c
• China 0
• Columbia 18c / 1d
• Czech Republic 1c
• Denmark 8c
• Egypt 1c
• Finland 10c
• France 58c / 3d
• Germany 7c
• Ireland 1c
• Israel 8c
• Italy 50c / 1d
• Japan 1c
• Mexico 6c
• Netherlands 40c / 1d
• New Zealand 15c / 1d
• Norway 3c
• Romania 0
• Russia 2c
• Singapore 1c
• South Africa 2c
• South Korea 1c
• Spain 32c
• Sweden 7c / 2d
• Switzerland 4c
• Taiwan 0
• Thailand 1c
• Venezuela 2c
• United Kingdom 59c / 1d
• United States 164c / 138 unconfirmed – under investigation / 5

         Cases diagnosed that met World Health Organisation criteria

         No ‘smooth’ breast implant cases to date, confirmed by FDA

 

Clinical presentation of deaths

 

Manufacturers

 

• Allergan/ McgHAN / iNAMED 91%
• Mentor 7%
• Sientra 1%
• Other
• Unknown

         Sept 26th 2019 (Within the Australian market place no access to smooth breast implants)

 

 

TGA (Australia) bans Macrotextured Implants

 

8 manufacturers

 

Allergan, Magor, Eurosilicone, Sebbin, Polyuthethane, air expanders

 

Allows Microtextured – Mentor Siltex, Allergan BRST but with additional study requirements and scrutiny. Australian Government – Department of Health Therapeutic Goods Administration

 

Texture Grading Classifications International Standard iso (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).14607

 

ISO Online browsing platform: available at https://www.iso.org/obp

JAMES/KINNEY 2018

Rough – Allergan Biocell, Mentor Siltex

BIA-ALCL Wright Giemsa Stain: anaplastic large cells

CA/CARE Allergan Biocell Prospective Trial McGuire et al. 2017, Updated 2019

17656 patients

31,985 implants

8 BIA-ALCL 1:2207

 

Global risks estimates

 

Australia, New Zealand (95 cases) textured market

 

risk 1:1000-1:10,000 for textured breast implants

Allergan Biocell 1:3345

Silimed polyurethane 1:2832

Mento Siltex 1:86029

25.7 to 1 ratio of Biocell to Siltex BIA-ALCL risk

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

 

 

Netherlands 1:6920 (40c) textured market

US 1:18,292 (164C, 2019) MIXED MARKET ALLERGAN:MENTOR

Therapeutic Goods Administration update 20 Dec 2018; 2 Magnusson M, et al.

The WHO acceptable cancer risk 1:1000000

NCCN guidelines – standard diagnosis/management

BIA-ALCL is retained in the capsule and continues to develop even after explantation if the capsule is left in place.

Diagnoses – PET/CT scan is critically important to look for spread of lymphoma

Surgery

En bloc resection: oncologic resection performed to remove cancer specimen in the whole

Total capsulectomy

Explantation

Exc mass

Exc biopsy node(s)

Consider contralateral

Consider delayed or immediate reconstruction

CHOEP – multiple required

GDP multiple required

Four rounds of brentuximab vedotin – preferred first line treatment nccn guideline

No data to support total capsulectomy can prevent BIA-ALC.

M.W.Clemens recommends only prophylactic capsulectomy in diagnosed patients

 

Currently (approximately) treatment for patients with BIA-ALCL: US/Australia/ Netherlands/Italy

 

60% Chemotherapy ideally with targeted immune therapy

45% Radiation

7% stem cell transplant

 

Most recent death September 2019

 

Delayed seroma presentation not initially checked for CD30

Progressed to SC, axillary lymph node mets and chest wall invasion

Treatment: Bilateral capsulectomy and brentuximab-CHOP

Progression of disease and death

 

Testing for BIA-ALCL

 

BIA-ALCL demonstrates hypoxia requirement.

CA9 detectable in serum – potential blood test for BIA-ALCL.

Breast reconstruction with breast implants does not have a higher rate of diagnosis with BIA-ALCL, in fact, more augmentation patients have been diagnosed, to date with BIA-ALCL. This demonstrates that operative strategy using anti-infection techniques does not influence BIA-ALCL.

To date, there are no cases of a tumour developing in the area of the mesh when used with breast implants. This is an indication that further research is needed, to identify if mesh could be a block that could be utilised with textured breast implants.

 

My Opinion

 

I have Allergan 410, (grade 3) textured breast implants, that have been withdrawn from the worldwide market and banned by the TGA (Australia). Before having my implants I did in depth research into breast implant manufacturers. I chose to have Allergan breast implants, due to their long standing history and reputation for making the highest quality breast implants. When I first found out about BIA-ALCL I was not overly concerned, however as the number of cases steadily increased I began to do more research. Further to the latest opinions by surgeons and oncologists, I have concluded there still seems to be mixed opinions, regarding the prevention of BIA-ALCL.

One reason I will not be having a capsulectomy is partially due to information provided by M.W.Clemens, regarding patients with breast implants that have received total capsulectomies and still developed BIA-ALC. The data currently does not support that a total capsulectomy can prevent BIA-ALC and with the only procedure that is currently known to prevent BIA-ALCL, being a prophylactic capsulectomy; I do not feel the risks justify this extremely invasive surgery. Considering how few confirmed cases there have been, out of the millions of individuals who have had textured breast implants around the world; I have decided to keep my breast implants. I will continue to monitor new cases of BIA-ALCL until further research demonstrates a higher risk of BIA-ALCL developing.

Your consultant should be able to advise which manufacturer and style of breast implant they used and you can ask if they are one of the Allergan breast implants that have now been withdrawn. Other manufacturers of textured shell breast implants have also been linked to BIA-ALCL. If your breast implants have a textured shell speak to your consultant about BIA-ALCL. Ask how your consultant will help you if you have any symptoms of BIA-ALCL, with regards to diagnostic testing. Ask for confirmation in writing, that if you are diagnosed with BIA-ALCL, you will not have to pay for the removal of your breast implants and revision surgery.

For more information about revision breast implants surgery go to  Revision Surgery

For more information on Breast reconstruction without breast implants go to  Alternatives