Published: 27 March 2020
Safety Information
Alert Communication
Mentor Siltex breast implants and anaplastic large cell lymphoma
27 March 2020
Johnson & Johnson Medical New Zealand Ltd is notifying surgeons that these devices carry a risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). Removal of these implants is not required, rather regular follow up of patients with these implants is recommended. The instructions for use supplied with the devices will now carry additional warnings and information for patients.
BIA-ALCL is a rare form of non-Hodgkin lymphoma specifically associated with breast implants.
Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Further information
Useful links
Advice for consumers and caregivers
- You do not need to have your implants removed
- You should have regular follow-up exams
- If you have tissue expanders implanted, please note that these are intended for temporary use only
- If you have any concerns about your implants, contact your implanting surgeon or your GP.
Information for healthcare professionals
- Breast implants are not considered lifetime devices. The longer they remain implanted, the higher the risk that the recipient will develop complications, potentially requiring further surgery
- Breast implants have been associated with the development of breast implant associated- anaplastic large cell lymphoma (BIA-ALCL), which is a rare form of non-Hodgkin lymphoma
- BIA-ALCL occurs more commonly with textured implants than with smooth implants
- Ensure that all your patients have regular follow-up exams
- Provide a copy of the relevant patient leaflet to all patients implanted in the last ten years, at their next check-up
- Review the most recent published guidance.
Products affected
| Product name | Sponsor |
|---|---|
| Mentor Siltex Round high profile Gel breast implant Cohesive I | Johnson & Johnson Medical New Zealand Ltd |
| Mentor Siltex CPG 333 Gel Breast Implant Cohesive III Tall Height, High profile | Johnson & Johnson Medical New Zealand Ltd |
| Mentor Siltex Contour Profile Becker 35 Expander | Johnson & Johnson Medical New Zealand Ltd |
| Mentor Siltex Round High Profile Gel Breast Implant Cohesive II | Johnson & Johnson Medical New Zealand Ltd |
| Mentor Siltex Round Becker 25 Expander Breast Implant Cohesive I | Johnson & Johnson Medical New Zealand Ltd |
| Mentor CPX4 Breast Tissue Expander | Johnson & Johnson Medical New Zealand Ltd |
| Mentor CPX4 Breast Tissue Expander with Suture | Johnson & Johnson Medical New Zealand Ltd |
| Mentor Smooth Round Cohesive I | Johnson & Johnson Medical New Zealand Ltd |
| Mentor Smooth Saline Mammary prosthesis with Diaphragm Valve | Johnson & Johnson Medical New Zealand Ltd |
| Mentor Smooth Round XTRA Gel Breast Implants | Johnson & Johnson Medical New Zealand Ltd |
| Mentor Memory Gel Xtra SILTEX Breast Implants | Johnson & Johnson Medical New Zealand Ltd |
Further information
Following a post market review of all breast implants and breast tissue
expanders supplied in Australia, the Therapeutic Goods Administration
(TGA) in Australia imposed conditions on all breast implant devices
that remained available. These conditions are also being applied to
breast implant devices supplied in New Zealand.
Useful links
