BREAST IMPLANTS AND ALCL

BACKGROUND

Over recent years, plastic surgeons have become aware of and studied a known link between breast implants that have a textured surface and the condition Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

BIA-ALCL is rare and, usually, eminently treatable. Current research suggests the risk of developing this condition in the UK is approximately 1 in 24,000 breast implants sold. For comparison the general incidence of breast cancer in the Ireland is 1 in 9 and affects women with and without breast implants equally. Aesthetic Surgery Ireland is unaware of any cases of BIA-ALCL cases in Ireland to date. (Jan 2019)

Not all textured surfaces are manufactured in the same way and they appear to convey different levels of risk, hence it is difficult to draw definite conclusions at this time. Texturing of an implant surface also offers advantages, particularly with more anatomically shaped implants. Hence many surgeons still advocate the use of textured implants for their patients. It is vital however, that the risks of using textured or smooth surfaced implants are fully discussed with all patients prior to surgery so that patients are able to make informed choices.

Several different companies manufacture breast implants for both aesthetic and reconstructive use. These implants can have different types of texturing on their surface and some research has indicated that BIA-ALCL might be related to a particular type of texturing or manufacturing processes. One major company, Allergan, produces implants known as Natrelle® with a surface called Biocell®. These implants are available worldwide but can only be sold under licence.
In Europe, all medical devices are regulated and must have a stamp of safety or licence. This is known as a CE mark. All manufacturers are periodically required to apply for re-certification of their CE mark to continue to supply their devices for patient use.

THE CURRENT SITUATION

Due to concerns over the possible link with Allergan’s textured surface (Biocell®), the CE mark has not been re-awarded for this product. Hence from late December 2018, Allergan’s textured implants are no longer available for patient use. This is a precautionary measure until more data becomes available and Allergan continues to work with the authorities to clarify the issue. The British Association of Aesthetic Plastic Surgeons has advised its member surgeons not to insert Allergan textured implants from today.
The CE mark for Allergan’s smooth surfaced implants has been renewed and their smooth implants are not affected. The failure to renew the CE mark for their textured implants does not at this stage affect any other manufacturer.

GUIDANCE FOR PATIENTS

Aesthetic Surgery Ireland advises that concerned patients need not take any action at this stage. They should continue their routine follow up with their surgeon and discuss any questions they have about their breast implants. There is no need to remove or exchange any current implants based on the most up-to-date scientific data available. Indeed, unnecessary surgery may cause additional harm in a small number of patients.