International regulatory actions for breast implants

International regulators monitor safety concerns related to breast implants, including the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Below are activities of international regulators.

United States Food and Drug Administration (FDA)

July 2019
There was a request from the FDA for Allergan to recall its BIOCELL textured breast implants. It was based on reports of worldwide BIA-ALCL cases and BIA-ALCL-related deaths. Allergan agreed and removed these products from the global market.

May 2019
The FDA released a statement detailing next steps following a public meeting. The meeting discussed the benefits and risks of breast implants. These included:

1. breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
2. systemic symptoms reported in patients receiving breast implants
3. the use of registries for breast implant surveillance
4. magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants
5. the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy
6. the use of real-world data and patient perspectives in regulatory decision making
7. best practices for informed consent discussions between patients and clinicians.

Medicines and Healthcare products Regulatory Agency (MHRA)

The MHRA (United Kingdom regulator)  collects and analyses information about BIA-ALCL from UK healthcare professionals and other sources.

The MHRA formed an independent expert advisory group. This group is the Plastic Reconstructive and Aesthetic Surgery Expert Advisory Group (PRAESEAG). They're reviewing breast implant risks and helping patients understand them. They will also provide guidance on future necessary MHRA action.

Health Products Regulatory Authority (HPRA)

In 2019, HPRA (Irish regulator) hadn't received any reports of BIA-ALCL. HPRA is a member of the European task force on BIA-ALCL.

Health Canada

May 2019
Health Canada released an update to the safety review. The Allergan Biocell implants were suspended due to the increased risk of BIA-ALCL. The Allergan Biocell implants are the only textured implants available in Canada.

June 2019
Health Canada issued a 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 on the rare but serious risk of BIA-ALCL. Allergan has voluntarily recalled BioCell breast implants as a precautionary measure.

European Union (EU)

The Allergan textured breast implants and tissue expanders have been withdrawn from Europe. This is due to a lapse in the EC certification. The TGA has published a statement relating to this matter.

July 2019
The Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) asked for a scientific opinion on breast implants and anaplastic large cell lymphoma. Eight key issues were under consideration to cover reconstructive and augmentation breast implants. The deadline was 31 August 2020.

Here are the issues with a brief description.

1. Describe the specific clinical indications and uses for various types of breast implants.
2. Describe what BIA-ALCL is, diagnostic criteria, treatment, and prognosis.
3. Indicate what is the state-of-the-art knowledge of incidence of BIA-ALCL.
4. Describe the state-of-the-art knowledge of the characterisation and classification of textures of the breast implant shells (is classification possible?).
5. Assess whether there's a causal link between breast implants and ALCL. Discuss what may be the potential and if possible, the most plausible pathogenesis mechanisms. Evaluate available information on incubation time, discuss the importance of knowledge on previous implants history of women developing BIA-ALCL. Examine whether preventive explantation is necessary if breast implants or specific subcategories of implants cause concern.
6. Describe the factors that may determine the risk of BIA-ALCL.
7. Briefly describe alternatives to breast implants (in context of ALCL)
8. Assess the need for more research and the best way to collect the missing data.

Agency of Medicine and Health Products Safety (ANSM)

February 2019
ANSM (French regulator) held a public forum on breast implants in February 2019. Watch the videos on YouTube: 

• Forum part 1
• Forum part 2

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.

National Institute for Public Health and the Environment (RIVM)

May 2019
The RIVM (Netherlands regulator) published the findings of its review of BIA-ALCL. In the Netherlands, the Minister has decided not to take further regulatory action on the devices.

Swiss Medic

In 2019, Swiss Medic (Swiss regulator) was waiting for the findings of the European Task Force on BIA-ALCL and SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) before making any regulatory decisions.

Swiss Medic asked Swiss Plastic Surgery for further clarification. They recommend smooth implants instead of textured implants where appropriate.

Federal Institute for Drugs and Medical Devices (BfArM)

In 2019, BfArM (German regulator) had not taken any action. The focus is on an informed decision by the patient and physician.

Ministry of Health, Labour and Welfare (MHLW) MHLW

June 2019
The MHLW (Japanese regulator) issued an Administrative Notice to Allergan. The notice requiring them to revise the precautionary statements provided in the Package Inserts in Natrelle breast implants. Allergan had until 8 July 2019 to comply.

Health Sciences Authority (HAS)

February 2019
The HAS (Singaporean regulator) convened an Expert Panel. According to the panel, textured implants seem to be more likely to cause ALCL. Although, the risk factors associated with the disease are still unclear. The HSA has taken the precautionary measure of not allowing the sale of Allergan Natrelle breast implants in Singapore.

Saudi Food and Drug Authority (SFDA)

In 2019, an SFDA Field Safety Notice cautioned surgeons and patients about using textured implants.

Brazilian Health Regulatory Agency (Anvisa)

In 2019, Anvisa suspended Allergan’s licence to supply. This was due to suspension of the CE certificate.

July 2019
Anvisa issued a recall notice for:

• Allergan Natrelle Textured Tissue Expander and Allergan Accessories
• Natrelle Textured Allergan Breast Implant
• Natrelle Textured Double Lumen Breast Implant
• Allergan Accessories covering all models and lot numbers for these products.

They hadn't recommended removing or replacing BIOCELL textured breast implants or tissue expanders at that point.