News Search

29 May 2018 | Products

Allergan Responds to Media Reports on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

29 May, 2018: Patient safety is Allergan’s first priority. Allergan’s breast implants have been used for more than 40 years in more than 100 countries, including Australia.[1]

Safety Profile of Allergan Breast Implants

Allergan manufactures a broad portfolio of breast implants, including those with textured and smooth surfaces. To date, we are not aware of any BIA-ALCL cases that have been found with other Allergan implants in Australia and New Zealand that do not include Biocell. Plastic surgeons and patients have a variety of reasons for selecting a textured implant, and patients are advised to have a thorough discussion with their plastic surgeon about the risks and benefits of each implant type to make an informed decision.

The safety profile of Allergan’s smooth and textured breast implants is supported by extensive pre-clinical device testing, more than a decade of U.S. and European clinical experience involving more than 160,000 women[2], as well as a large number of peer-reviewed and published studies.[2]  

Allergan’s Global Breast Implant Warranty

On April 1st, 2018 Allergan became the first implant manufacturer to add the rare events of BIA-ALCL and capsular contracture Baker Grade III/IV to their global breast implant warranty. The warranty provides out-of-pocket surgical cost assistance toward the removal of the breast implant(s) and the associated scar tissue (complete capsulectomy). Allergan will also provide replacement implant(s) at no charge.  

Regulatory Reviews of BIA-ALCL 

In response to recent media reports of breast implants and BIA-ALCL, it is important for patients and physicians to understand the facts around the benefits and risks of breast implants. 
 
Over the past 15 years, there has been scientific discussion about cases of ALCL being reported very rarely in women who have also had breast implant procedures. The national health regulator in the UK (the Medicines & Healthcare Products Regulatory Agency or MHRA),[3] the French regulator (Agence Nationale de Sécurité du Médicament et des Produits de Santé or ANSM),[4] the U.S. regulatory authority (the Food and Drug Administration or FDA),[5] and Australia’s Therapeutic Goods Administration (TGA)[6] have continuously evaluated these case reports and acknowledge that the cases of BIA-ALCL represent a very low occurrence in the estimated 5-10 million women around the world who have had breast implant procedures. 
 
Based on all of the available scientific information, the MHRA, the ANSM, the U.S. FDA and the TGA are not recommending any change in current best practice to post-implant care and check-ups[3-6]. Women with breast implants should be advised to perform regular breast self-examination and consult their healthcare provider if they notice changes. Patients should talk with their healthcare provider for medical guidance, if concerned. Physicians are reminded that any suspected cases should be referred to an appropriate specialist for evaluation and treatment. 

Patient and professional guidance

Allergan strongly refutes specific media reports in News Corp coverage, which states, “Allergan, the company that makes Biocell implants, said women fitted with them did not need regular screening to detect cancer and instead it was up to surgeons to discuss the risks and benefits with patients.” These latest recommendations are compiled by the TGA, based on their review of available data.  Therefore it is false and misleading to attribute this statement to Allergan and this has now been retracted by News Corp.
 
Consumers should refer to the advice of the TGA provided at https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma
 
Medical professionals can find additional guidance from Australasian Society of Aesthetic Plastic Surgeons here: https://aestheticplasticsurgeons.org.au/media/separating-facts-fiction-relation-cancer-risk-breast-implants/
 
In line with TGA guidance, Allergan recommends specific concerns should be discussed with a health professional. Product information, including known warnings and precautions is included with Allergan breast implants.
 
When diagnosed and treated early by a surgical specialist, BIA-ALCL has a good prognosis.[7,8] Worldwide, BIA-ALCL has been reported with multiple different implant manufacturers.[9-13] Direct causality has not been established with implants from a specific manufacturer. 

Ongoing evaluation

Allergan fully supports informed consent for patients and has included information on BIA-ALCL in the surgeon ‘Directions for Use’, which are provided with the implants to aid an effective consultation. Allergan continues to collaborate with worldwide regulatory authorities around this disease, providing them with a complete safety data set and full transparency regarding data that may elucidate any causative factors. We routinely review and update our product labels as appropriate. 
 
Allergan also continues to work with the medical and scientific community to further our understanding of this rare disease, including implant surface characteristics (smooth and textured), the body’s biological response to them and the importance of aseptic surgical procedures.
 

MEDIA CONTACTS

Mark Marmur, Corporate Affairs
‭+44 7725 758 677‬ ‬‬‬‬‬‬‬‬‬

REFERENCES 

1. International Regulatory Data on File 
2. DOF: BREAST 001-Dec 2014
7. Kim B et al. Updated results from a structured expert consultation process, Plastic Reconstructive Surgery Global Open, 2015 Feb 6;3(1):e296.
8. Clemens MW et al. Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol. 2016 Jan 10;34(2):160-8. doi: 10.1200/JCO.2015.63.3412. Epub 2015 Nov 30.
9. Jewell M et al. Anaplastic large T-cell lymphoma and breast implants: a review of the literature. Plast Reconstr Surg. 2011;128:651-61.
10. Lazzeri D et al. ALK-1-Negative Anaplastic Large Cell Lymphoma Associated With Breast Implants: A New Clinical Entity. Clin Breast Cancer. 2011; 11:283-96.
11. Kim B et al. Anaplastic Large Cell Lymphoma and Breast Implants: A Systematic Review. Plast. Reconstr. Surg. 2011; 127: 2141-50
12. Largent J et al. Risk of lymphoma in women with breast implants: analysis of clinical studies. Eur J Cancer Prev. 2012;21:274-80. 
13. de Jong D et al. Anaplastic large-cell lymphoma in women with breast implants. JAMA. 2008;300:2030–2035.
Media Contacts
Mark Marmur
Global Corporate Media Relations
Tel: +1 (862) 261 7558
Fran DeSena
U.S. Product Media Relations
Tel: +1 (201) 427-8762

Karina Calzadilla
Investor Relations
Tel: +1 862 261 7488