Risk of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)

The Health Sciences Authority (HSA) would like to alert the public to the risk of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare type of lymphoma that usually develops around breast implants. This is in view of more information that has recently come to light on this risk. HSA advises persons with breast implants to consult their doctors if they experience pain or swelling around their implants after the surgical incision has healed. Those who are considering breast implants should discuss the benefits and risks of the different types of implants with their doctors.

About breast implants & BIA-ALCL

2    Breast implants have a silicone outer surface that is either smooth or textured. Globally, the majority of persons with breast implants who have developed BIA-ALCL have had textured implants. The estimated incidence rates of BIA-ALCL reported in literature[1] range from one in 3,817 to one in 30,000 persons with textured breast implants.  Further review of the global reports on BIA-ALCL indicates a relatively higher incidence rate in those implanted with macro-textured breast implants.

3    There are also a few unconfirmed reports of BIA-ALCL in patients who have received smooth-surfaced implants[2]. The possible association is currently being investigated by regulators globally.   

4    BIA-ALCL is a cancer of the immune system and not a type of breast cancer. It usually involves a swelling around the implant and has been reported to occur as early as 1 year and as late as 37 years after the breast implant surgery. An estimated 10 to 35 million breast implants have been implanted worldwide (as approximated in the scientific literature).  There have been approximately 800 reports (both confirmed and unconfirmed reports) of BIA-ALCL.

5    If diagnosed early, BIA-ALCL can be successfully treated with surgery. However, in cases where the cancer has spread to other parts of the body, further treatment such as radiation or chemotherapy and targeted immunotherapy have been used.

Local situation

6    Since 2017, following emerging scientific reports on BIA-ALCL, HSA has required manufacturers of breast implants to include cautionary statements regarding the risk of BIA-ALCL in the package inserts of breast implants registered in Singapore.  HSA had also informed relevant healthcare professionals in October 2017 to highlight the risk of BIA-ALCL and the possible association with textured surface breast implants to patients, and to report any BIA-ALCL cases they encounter to HSA.

7    Given the growing global concerns on BIA-ALCL, HSA convened an Expert Panel[3] in February 2019 to assess the evolving situation and risk of BIA-ALCL as well as relevant mitigation measures.  Based on current scientific data, the Expert Panel assessed that textured surface implants appeared to be associated with a higher risk than the smooth ones. However, the risk factors associated with the disease are still unclear. The panel noted that BIA-ALCL occurrences are rare and the associated mortality rates remain low. While regulatory agencies are actively investigating the risk of BIA-ALCL, it is advised that timely detection and appropriate clinical management remain the key factors in managing BIA-ALCL effectively.

8    There are currently eight registered brands of breast implants in Singapore. Macro-textured breast implants are associated with the highest risk of BIA-ALCL, and the Allergan Natrelle breast implant is the only macro-textured breast implant registered in Singapore.  HSA has taken the precautionary measure of disallowing the sale of the Allergan Natrelle breast implant in Singapore since April 2019. This decision was supported by the Expert Panel.    

9    To date, HSA has received one report of BIA-ALCL locally.  The patient, who was diagnosed early, is recovering.

Advisory to consumers

10    HSA advises persons considering breast implants for reconstruction or augmentation purposes to discuss their options with their doctors, including the risks and benefits of different types of implants.   

11    HSA advises persons who have breast implants to take note of the following:

• Consult your doctor if you develop swelling, lumps or pain around your implant after the surgical incision has healed.

• Conduct regular breast self-examination and continue with the periodic follow-up post-implantation, as scheduled by your doctor. Post-operative follow-up plays an important role for early detection of the disease.    

• While removal of breast implants is not necessary if you have not experienced any problems with the implant, please consult your doctor to discuss your options if you have concerns.       

12    Professor Ong Yee Siang, Head and Senior Consultant of Plastic, Reconstructive and Aesthetic Surgery at the Singapore General Hospital and HSA’s Expert Panel member on Breast Implants, advises: “BIA-ALCL is a rare type of lymphoma that could develop around breast implants. Removal of breast implants is not necessary for patients implanted with breast implants if you have no symptoms of swelling, lumps or pain around your implant. Consult your doctor to discuss your options if you are concerned. In addition, patients considering breast implants should discuss the risks and benefits of the different types of implants with your doctor.”

13    HSA has prepared an infographic on the risk and presenting symptoms of BIA-ALCL, as well as a list of frequently asked questions on this topic. Please refer to Annexes A and B of the pdf version or via the links below. These materials can also be found on our website at www.hsa.gov.sg/bia-alcl. 

14    HSA will continue to closely monitor the global developments and review the evolving scientific information regarding this safety issue. HSA will update the public with more information should there be any significant new findings.

HEALTH SCIENCES AUTHORITY
SINGAPORE
10 MAY 2019

Download PDF version here [PDF, 720 KB]

Download PDF version here Annex A [PDF, 289 KB]

Download PDF version here Annex B [PDF, 117 KB]

[1] Loch-Wilkinson et al, 2017 and Doren et al, 2017 (Plastic Reconstruction Surgery)

[2] “Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”, 2019, FDA, US Food and Drug Administration https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

[3] The Expert Panel comprises a group of healthcare professionals from both public and private hospitals.