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

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.

Although the HPRA has not received any reports of BIA-ALCL through its medical device vigilance reporting system, we encourage individuals and healthcare professionals to report suspected or confirmed cases of BIA-ALCL to the HPRA. Our colleagues in the Medicines and Healthcare Products Regulatory Authority, in the UK, have estimated that this disease occurs in approximately one individual for every 24,000 implants sold. The 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 disease.

The investigation into BIA-ALCL is ongoing and, as with all medical device issues, an evidence-based approach is being taken. As awareness of this disease increases, the number of cases reported worldwide is increasing. Although most cases of BIA-ALCL reported to date are in patients with textured implants, proof of a causal relationship has not been established and the mechanism for the development of BIA-ALCL is yet to be determined.


Precautionary action by the French Competent Authority

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.


Information for Individuals Considering Breast Implant Surgery

As awareness of this condition and the number of internationally confirmed cases of BIA-ALCL increase the HPRA would like to reiterate the importance for anyone considering breast implant surgery to discuss the risks and benefits with their surgeon. Clinicians should discuss the potential risk of BIA-ALCL when consenting new individuals, and with any individual returning for review of their breast implants. If you have any health concerns relating to breast implants, please consult your GP or implanting surgeon.


Information for Individuals with Breast Implants

Symptoms of BIA-ALCL:

  • The most common symptom noted is a collection of fluid developing around one or both breast implants, more than one year after surgery has been completed.
  • 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 often be successfully managed by removal of the implant and its surrounding fibrous capsule. In rare occasions, 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. In very rare occasions, patients may die from this disease.

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, there is no evidence to suggest that healthy individuals without symptoms should have a removal of breast implants.

If you have experienced any issues relating to your breast implant and would like to inform the HPRA, reports can be made online through our user reporting system. However, if you have any reservations or if you are uncertain about completing the online report form, you can contact the medical devices team at HPRA directly by calling 01 6764971. Your call will be directed to a member of the medical devices vigilance team. The user report can also be submitted to the HPRA by post.


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.