Breast implants: Evidence and safety reviews
In our commitment to openness and transparency, we publish summaries of our safety reviews on medical devices like breast implants. These summaries complement other safety-related information to help people in Canada make informed decisions.
The summaries outline what was assessed, what was found and what actions, if any, were taken by Health Canada.
You can subscribe to receive information on authorized breast implants. Timely and relevant updates include:
- general information
- risk communications
- safety or recall information
- current data on breast implant-associated anaplastic large cell lymphoma reported to Health Canada
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On this page
Announcements
Announcements: 2024
Announcements: 2022
- Health Canada launches opt-in subscription service for breast implant updates (April 6)
- Health Canada publishes Canadian surveillance data blog on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) (April 6)
- Health Canada updates its safety review of BIA-ALCL (April 6)
Announcements: 2019
- Health Canada suspends Allergan's licences for its Biocell breast implants after safety review concludes an increased risk of cancer (May 28)
- Health Canada's intention to suspend Allergan's Biocell breast implants licences (April 4)
- Health Canada to update its safety review of breast implants (February 12)
- Health Canada encourages medical device incident reporting (January 15)
Announcements: 2017
Pre-market reviews
Pre-market reviews: 2001
Safety reviews and decisions
Scientific and regulatory considerations about breast implants are found in the summary safety reviews and decisions on the drug and health product register. An up-to-date list follows.
Summary safety reviews
Safety reviews and decisions: 2024
Safety reviews and decisions: 2022
Safety reviews and decisions: 2019
Summary safety reviews: 2017
Summary basis of decisions
Summary basis of decisions: 2017
- Mentor MemoryGel CPG breast implants cohesive III (October 10)
- Mentor MemoryGel silicone gel-filled breast implants (October 10)
Summary basis of decisions: 2016
Summary basis of decisions: 2015
Summary basis of decisions: 2014
- Natrelle silicone-filled breast implants - smooth shell with barrier and Natrelle silicone-filled breast implants - textured shell with barrier layer (January 17)
- Natrelle highly cohesive silicone-filled breast implants (January 17)
- Mentor MemoryGel CPG breast implants cohesive III (January 17)
- Mentor MemoryGel silicone gel-filled breast implants (January 17)
Summary basis of decisions: 2012
- Natrelle silicone-filled breast implants - smooth shell with barrier layer and Natrelle silicone-filled breast implants - textured shell with barrier layer (September 25)
- Natrelle highly cohesive silicone-filled breast implants (September 25)
- Mentor MemoryGel CPG breast implants cohesive III (August 9)
- Mentor MemoryGel silicone gel-filled breast implants (August 9)
Summary basis of decisions: 2011
- Natrelle silicone-filled breast implants - smooth shell with barrier layer and Natrelle silicone-filled breast implants - textured shell with barrier layer (November 10)
- Natrelle highly cohesive silicone-filled breast implants (November 10)
- Mentor MemoryGel CPG breast implants cohesive III (September 27)
- Mentor MemoryGel silicone gel-filled breast implants (September 27)
Summary basis of decisions: 2010
- Mentor MemoryGel CPG breast implants cohesive III (September 23)
- Mentor MemoryGel silicone gel-filled breast implants (September 23)
- Natrelle silicone-filled breast implants - smooth shell with barrier layer and Natrelle silicone-filled breast implants - textured shell with barrier layer (August 25)
- Natrelle highly cohesive silicone-filled breast implants (August 25)
Summary basis of decisions: 2009
- Mentor MemoryGel CPG breast implants cohesive III (September 18)
- Mentor MemoryGel silicone gel-filled breast implants (September 18)
- Natrelle silicone-filled breast implants - smooth shell with barrier layer and Natrelle silicone-filled breast implants - textured shell with barrier layer (September 18)
- Natrelle highly cohesive silicone-filled breast implants (September 18)
Summary basis of decisions: 2008
- Mentor MemoryGel CPG breast implants cohesive III (July 8)
- Mentor MemoryGel silicone gel-filled breast implants (July 8)
- Natrelle silicone-filled breast implants - smooth shell with barrier layer and Natrelle silicone-filled breast implants - textured shell with barrier layer (July 8)
- Natrelle highly cohesive silicone-filled breast implants (July 7)
Summary basis of decisions: 2006
- MemoryGel silicone gel-filled breast implants (October 20)
- CPG gel breast implants cohesive III (October 20)
- Inamed style 410 silicone-filled breast implants (October 20)
- Inamed silicone-filled breast implants - smooth shell with barrier layer and Inamed silicone gel-filled breast implants - textured shell with barrier layer (October 20)