Like the TGA in Australia, international regulators also monitor safety concerns related to breast implants, including the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). International regulators’ recent activities are summarised below.
FDA (USA regulator)
July 2019 - On 25 July 2019, the United States Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan agreed and is removing these products from the global market.
May 2019 - The United States Food and Drug Administration (FDA) released a statement on 2 May 2019 detailing the steps that it would take following a public meeting held by the FDA on 25 and 26 March 2019. The meeting discussed the benefits and risks of breast implants indicated for breast augmentation and reconstruction, including:
- breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
- systemic symptoms reported in patients receiving breast implants
- the use of registries for breast implant surveillance
- magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants
- the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy
- the use of real-world data and patient perspectives in regulatory decision making
- best practices for informed consent discussions between patients and clinicians.
MHRA (United Kingdom regulator)
The Medicines and Healthcare products Regulatory Agency (MHRA) continues to collect and analyse information from UK healthcare professionals and other sources about BIA-ALCL to build a fuller picture of the occurrence of this rare disease in association with breast implants.
The MHRA has formed an independent expert advisory group, the Plastic Reconstructive and Aesthetic Surgery Expert Advisory Group (PRAESEAG), who are reviewing the risks associated with breast implants and helping to provide further understanding of the disease and potential risks to patients. They will also provide guidance on future necessary MHRA action.
HPRA (Irish Regulator)
HPRA has not received any reports of BIA-ALCL at this time. HPRA is a member of the European task force on BIA-ALCL and is working closely with their partners to share information and develop an understanding of this disease.
Health Canada (Canadian regulator)
Health Canada, on 28 May 2019, released an update to the safety review that was being undertaken in relation to BIA-ALCL. The outcome has been the suspension of Allergan Biocell implants from the market in Canada due to the increased risk of BIA-ALCL with textured implants. The Allergan Biocell implants are the only textured implants available in Canada.
On 7 June 2019 Health Canada issued a Medical Device Recall for Allergan’s Biocell Style 168 textured, round saline filled breast implants; Style 163, 468, 363LF textured, anatomical saline-filled breast implants; Style 120, 115, and 110 round silicone-filled breast implants. This recall is based upon the rare but serious risk of BIA-ALCL. Allergan has voluntarily recalled BioCell breast implants as a precautionary measure.
EU actions
The Allergan textured breast implants and tissue expanders have been withdrawn from Europe due to a lapse in the EC certification. The TGA has published a statement relating to this matter.
On 17 July 2019 the Scientific Committee on Health Environmental and Emerging Risks (SCHEER) has published a request for a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma. There are eight key issues under consideration are intended to cover reconstructive and augmentation use of breast implants. A deadline of 31 August 2020 has been indicated.
The issues being examined are listed below with a brief description of each.
- To briefly describe what are the specific clinical indications and uses for various types of breast implants.
- To briefly describe what BIA-ALCL is, what the specific diagnostic criteria are, what the state of the art treatment is, and what the prognosis of the disease is.
- To indicate what is the state of the art knowledge in terms of incidence of BIA-ALCL.
- To describe the state of the art knowledge regarding the characterisation and classification of textures of the breast implant shells (e.g. is classification possible?).
- To indicate whether a causal relationship between breast implants and ALCL can be established based on the evidence available to date. To discuss what may be the potential and if possible the most plausible pathogenesis mechanisms. To evaluate the available information on incubation time, and in relation to this, discuss the importance of knowledge on previous implants history of women developing BIA-ALCL. To evaluate if preventive explantation is warranted in case reasons for concern related to breast implants or specific subcategories of breast implants are identified.
- To describe the factors that may determine the risk of BIA-ALCL.
- In the context of ALCL to briefly describe alternatives to breast implants.
- Where relevant to identify needs for further research and the best ways to collect the missing data regarding breast implants and ALCL.
ANSM (French regulator)
The Agency of Medicine and Health Products Safety (ANSM) held a public forum on 7 and 8 February 2019 to hear submissions relating to breast implants.
The minutes from this meeting, along with the information from the FDA public meeting, peer-reviewed publications, and their legislation, are the basis for the decision by the ANSM, published on 4 April 2019, that macro-textured and polyurethane-coated implants would no longer be supplied in France.
RIVM (Netherlands regulator)
The National Institute for Public Health and the Environment (RIVM) in the Netherlands published the findings of its review of BIA-ALCL on 17 May 2019. As a result, the Minister has decided that the devices will not be subject to further regulatory action in the Netherlands, at this time.
Swiss Medic (Swiss regulator)
Swiss Medic intends to wait for the findings of the European Task Force on BIA-ALCL and SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) to further evaluate the disease BIA-ALCL before making any regulatory decisions.
Swiss Medic has sought further clarification of the available information from Swiss Plastic Surgery who have recommended the use of smooth implants rather than textured implants where permitted by the clinical situation.
BfArM (German regulator)
The Federal Institute for Drugs and Medical Devices (BfArM) has not taken any action; the emphasis has been placed on an informed decision by the patient and physician according to the current state of knowledge.
MHLW (Japanese Regulator)
The Ministry of Health, Labour and Welfare (MHLW) following advice from its advisory body, the Pharmaceuticals and Medical Devices Agency (PMDA), issued an Administrative Notice to Allergan on 7 June 2019, requiring them to revise the precautionary statements provided in the Package Inserts in Natrelle breast implants. Allergan had until 8 July 2019 to comply.
HSA (Singaporean regulator)
The Health Sciences Authority (HSA) convened an Expert Panel in February 2019 which advised that textured surface implants appeared to be associated with a higher risk of ALCL. However, the risk factors associated with the disease are still unclear. The HSA has taken the precautionary measure of disallowing the sale of Allergan Natrelle breast implants in Singapore since April 2019.
SFDA (Saudi regulator)
The Saudi Food and Drug Authority (SFDA) has issued a Field Safety Notice advising surgeons and patients to carefully consider the use of textured implants.
Anvisa (Brazilian regulator)
The Brazilian Health Regulatory Agency (Anvisa) has suspended Allergan’s licence to supply due to suspension of the CE certificate.
On 25 July 2019, Anvisa issued a recall notice for Allergan Natrelle Textured Tissue Expander and Allergan Accessories, Natrelle Textured Allergan Breast Implant, and Natrelle Textured Double Lumen Breast Implant and Allergan Accessories covering all models and lot numbers for these products. At this stage they have not made a recommendation for removal or replacement of BIOCELL textured breast implants or tissue expanders in asymptomatic patients.