Breast implants: Evidence and safety reviews

Announcements

Announcements: 2024

• Health Canada publishes its safety review on breast implant illness representative symptoms and diseases (August 9)

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

• Breast implants - risk of anaplastic large cell lymphoma (BIA-ALCL) (November 24)
• Health Canada safety review finds low incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) reported in Canada (November 24)

Pre-market reviews

Pre-market reviews: 2001

• Preparation of a premarket review document for breast implant and tissue expander device licence applications (February 25)

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

• Breast Implants - assessing the potential risk of breast implant illness representative symptoms and diseases (August 9)

Safety reviews and decisions: 2022

• Breast implants - assessing the potential risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) (April 6)

Safety reviews and decisions: 2019

• Breast implants - assessing the potential risk of cancer (breast implant-associated anaplastic large cell lymphoma) (May 28)

Summary safety reviews: 2017

• Breast implants - assessing the potential risk of cancer (breast implant associated-anaplastic large cell lymphoma) (November 24)

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

• Mentor MemoryGel CPG breast implants cohesive III (May 9)
• Summary basis of decision for Mentor MemoryGel silicone gel-filled breast implants (May 9)

Summary basis of decisions: 2015

• Mentor MemoryGel CPG breast implants cohesive III (May 21)
• Mentor MemoryGel silicone gel-filled breast implants (May 21)
• Ideal saline-filled breast implants (January 16)

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)