Allergan Textured Breast Implants 

Background

Allergan is a manufacturer of a range of breast implants with both textured and smooth surfaces. Following a decision by the Notified Body, LNE GMED, not to renew the CE Certificates for Allergan’s textured breast implants, including tissue expanders. Allergan has initiated a withdrawal of all remaining stock of these implants. As the CE certificates expired 16th December, Allergan has also ceased supply of textured implants pending further review by the notified body.

Notified bodies are independent certification organisations who assess the conformity of a device with the relevant medical devices legislation before the device is placed on the European market. In this instance, the notified body review was being carried out within the context of routine recertification (renewal of the CE mark) activities.

Following the decision by LNE GMED, the French Competent Authority ANSM, asked Allergan to recall the products in stock from health facilities in France. Allergan has extended this action across all European markets and will issue a Field Safety Notice (FSN) to inform healthcare professionals of this recall. A field safety notice is a standard notification via which manufacturers communicate medical device market actions. This notice will be sent to hospitals who have received these implants outlining the steps they should take. Breast implants with a smooth surface manufactured by Allergan are not impacted by this action. For a full list of the products included in this recall, please see the FSN issued by Allergan.

Breast implants in general have been subject to recent regulatory scrutiny in relation to their potential link to a rare form of cancer; Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). European and International clinicians, scientists and regulators have been working together to assess the potential association between breast implants and this rare lymphoma. Although most cases of BIA-ALCL reported worldwide to date are in patients with textured implants, scientific proof of a causal relationship between the surface texture of implants and BIA-ALCL has not been established and the mechanism for the development of BIA-ALCL is yet to be determined. The HPRA is continuing to closely monitor and assess the issue of BIA-ALCL. For more information on BIA-ALCL, see the dedicated section of the HPRA Website.

Information for Individuals who may be Concerned about their Breast Implants

Allergan has confirmed that this action is not based on any new scientific evidence about these products and ANSM have not identified an immediate risk to the health of individuals with these implants; the HPRA understands, therefore, that this recall is a precautionary measure. If you have not noticed any issues with your breast implant(s) you should continue with your standard follow-up care as directed by your doctor.

However, any individual who has any concerns or thinks they may have symptoms (in particular fluid collection, pain or swelling) associated with their breast implant(s) should talk to their doctor.

Reports of adverse incidents associated with breast implants can be made online through our user reporting system. However, if you have any reservations or if you are uncertain about completing the online report form, you contact the HPRA by emailing devices@hpra.ie. The user report can also be submitted to the HPRA by post.