My HPRA: Register

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

Last Updated: 27 September 2019

Background

BIA-ALCL is a rare type of non-Hodgkin’s Lymphoma, occurring in individuals who have previously had synthetic breast implants inserted. It was first described in 1997 and was given World Health Organisation (WHO) provisional recognition as a type of ALCL in 2016.

It can be difficult to accurately explain the risk of developing rare conditions such as BIA-ALCL, but it is important that individuals with breast implants, and those considering surgery with breast implants, are aware of the potential risks that may be associated with their breast implants. As international regulators and scientists have concentrated research efforts on this condition over the past number of years, the risk of developing BIA-ALCL has been shown to be more common than first thought, but it still remains a rare condition.

Breast implants may have a range of surface textures of an increasing degree of texturing; these are commonly known as smooth, microtextured, macrotextured or Polyurethane Foam Coated. The degree of texturing is thought to affect the ability to successfully position the implant and to reduce the risk of contracture of the capsule (scar tissue) over time.

In reports made to medical device regulators worldwide, the majority of cases of BIA-ALCL have been seen in implants manufactured by Allergan with an implant surface called BIOCELL. A recent journal article estimated there is one case of BIA-ALCL for every 3,345 of these specific implants used. Allergan implants with a BIOCELL surface had been commonly used in Ireland prior to a European recall of these implants in December 2018. The BIOCELL surface was used in a range of Allergan breast implants including:

  • Natrelle Inspira Textured (But not Natrelle Inspira Smooth implants),
  • Natrelle 410 and 510

Please note that these implants may have been previously marketed under the brand names ‘McGhan’ or ‘Inamed’.

Other breast implants may have a different risk of developing BIA-ALCL and the risk appears to be related to the degree of surface texturing on the breast implant. Implants with a lesser degree of surface texturing appear to have a less common association with BIA-ALCL.  A range of breast implants with different degrees of surface texturing have been used in Ireland.  

The HPRA encourages individuals and healthcare professionals to report suspected or confirmed cases of BIA-ALCL to the HPRA so that we can better understand this rare condition. HPRA is a member of the European task force on BIA-ALCL and we work closely with our partners to share information and understanding on this condition.

Information for Individuals with Breast Implants

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL), is a rare cancer of the immune system. It is not breast cancer, which forms from cells in the breast, but instead a cancer that grows in the fluid and scar tissue that forms around a breast implant. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit.

Symptoms of BIA-ALCL:

  • The most common symptom noted is a collection of fluid developing around one or both breast implants, well after the surgical incision has healed.
  • This fluid may develop many years after the surgery was completed.
  • The fluid collection often results in an increase in size of the affected breast. In some cases, it can affect both sides.
  • Sometimes this disease may present as a lump near the implant or in the tissue that has developed around the breast implant.
  • It is important to note that fluid can collect around your breast implant for other reasons that are not BIA-ALCL, including as part of the healing process after surgery.

 

If you have noticed a fluid collection around your breast implant, or you have any other concerns about your breast implant, you should speak to your implanting surgeon or your GP.

In the vast majority of patients who are diagnosed with BIA-ALCL, the cancerous cells are confined to the seroma fluid, with no local spread, and the condition can normally be successfully managed by removal of the implant and its surrounding fibrous capsule. In a small number of cases of BIA-ALCL, this cancer can spread beyond the local area and may involve distant tissues. In such cases, other treatments such as chemotherapy and radiotherapy may be required. Worldwide, there have been a small number of deaths reported. The TGA in Australia have identified 4 deaths over the past 10 years, the UK MHRA have received reports of 3 deaths in women with BIA-ALCL with one of these 3 cases meeting the diagnostic criteria. The US FDA, have indicated that, as of September 2018, they had received 9 reports of patient deaths that may be attributable to BIA-ALCL

The HPRA advises that individuals with breast implants should continue with their normal clinical follow up plan unless they have noticed a build-up of fluid or a lump, in which case they should seek advice from their healthcare professional. In relation to BIA-ALCL, experts have not recommended that healthy individuals without symptoms should have a removal of breast implants.

If you have experienced any issues relating to your breast implant you should, in the first instance, contact your health care professional. If you would subsequently like to report the issue to the HPRA, reports can be made online through our user reporting system or can be posted to the HPRA. Reports can also be submitted by your health care professional as outlined below.

Information for Healthcare Professionals

Healthcare professionals performing breast implant surgery, undertaking follow-up on individuals with previous breast implants (including pathologists) or screening individuals as part of a national breast screening programme should be aware of the potential development of BIA-ALCL. Symptoms may present many years after initial surgery and for this reason healthcare professionals, such as General Practitioners, who may be a first point of contact for an individual with a previous breast implant and a new onset of fluid build-up or swelling around the breast, should also be aware of BIA-ALCL.

Histological analysis of seroma fluid or excised tissue is the mainstay of diagnosis, and CD30 and ALK status is key to the diagnosis of BIA-ALCL. For disease localised to the implant capsule, in the majority of cases, removing the implant and any capsular tissue surrounding it successfully treats the disease. For more disseminated disease, treatment may include chemotherapy and radiotherapy.

The HPRA encourages healthcare professionals to report all cases of ALCL in association with breast implants to the HPRA. As part of a report, the following information will greatly aid the follow-up of these cases:

  • Device details (Manufacturer and Model, Surface Texture of the implant);
  • Details of any previous breast implants (Manufacturer and Model, Surface Texture of the implant);
  • Implantation date details (Initial, Revision and Explantation if applicable);
  • Diagnostic pathology specifics of the case (including CD30 and ALK status);
  • Details of any previous implants;
  • Clinical Symptoms and Management to date.

 

International activities

FDA (USA)

In March 2019, the United States regulatory agency, the FDA, convened a panel to discuss the safety of breast implants. Among the conclusions drawn from this two day meeting, which included clinicians, patients and representatives from the manufacturers, was the following statement ‘While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis’. In July 2019 the FDA requested that Allergan, a manufacturer of a certain type of implants with a surface texture known as BIOCELL, recall these implants from the US market, due to an association with a higher risk of BIA-ALCL than other textured implants available on the US market (See below for more details of this recall). Note; these products had already been withdrawn in Ireland in December 2018.

Health Canada

In May 2019 the Canadian regulatory agency, Health Canada suspended the Canadian licences for some of the macrotextured breast implants manufactured by Allergan, meaning these implants could no longer be sold in Canada. Following a request by Health Canada, Allergan also recalled the specific breast implants from the Canadian market. Health Canada have explained that they made this decision as they had found the rate of BIA-ALCL to be significantly higher in individuals with the affected implants, when compared to other types of breast implants.

TGA (Australia)

On the 26th September 2019 the Australian regulatory agency, the Therapeutic Goods Administration (TGA), announced that it had taken regulatory action in relation to all breast implants and tissue expanders on the Australian market. The regulatory actions taken include the suspension of some breast implant devices from the market and the imposition of new conditions on supply of remaining breast implant devices. There has also been voluntary removal of some breast implant devices from the market. For full details of the TGA action, please see their website.

 

Europe

With the exception of France the position across Europe is that following the withdrawal of the Allergan textured breast implants, other breast implants remain available on the European market. On 4 April 2019, the French competent authority (ANSM) announced a decision to take precautionary action against macrotextured and polyurethane foam coated breast implants in France. Under the European legislation which governs medical devices, a national decision of this nature is subsequently reviewed by the European Commission and may be extended to other member states. The HPRA will continue to engage with clinicians, the European task force and our international partners to monitor these devices and new data as it emerges.

Global Recall of Allergan’s BIOCELL Breast Implants and Tissue Expanders

On the 24th July 2019, following a request from the US FDA, Allergan initiated a global recall of their breast implants and tissue expanders with a BIOCELL surface texture. These implants had already been recalled from the European market in December 2018, following a decision by a notified body to not renew the CE-mark for the implants.

The FDA have indicated that their request in July was made due to the risk of BIA-ALCL associated with implants with a BIOCELL surface. At the time of the extended recall, the FDA also updated their information about reports received relating to BIA-ALCL, advising that they have received reports relating to 573 unique cases of BIA-ALCL, including 33 patient deaths worldwide. These reports originate from both within the USA and also outside the USA.