Update on ALCL and Textured Mammary Implants

14 July 2016

Dear Members

In light of two announcements on the 6 July 2016 by the French Regulator: ANSM, I feel that this it is important that all of our members are aware of the issues raised.

The first announcement is regarding the cases of Anaplastic Large Cell Lymphoma (ALCL) that have been identified in France in women with breast implants. To date, 29 cases have been identified. Allergan textured implants had been used in 27 of these patients. The comment is made that this over-representation of Allergan implants in ALCL has been reported in other data series around the world. It is however noted that ALCL remains a very rare condition with around 400,000 implants having been inserted in France between 2007 and 2014. No action is currently suggested other than properly informing patients and the action required in the case of any post-operative concern about a possible ALCL diagnosis.

The second announcement is regarding the biocompatibility of textured mammary implants. The regulators state that insufficient evidence has been presented by any of the manufacturers regarding the biocompatibility of textured mammary implants. They have asked for evidence to be presented within a 12 month period. This follows on from a statement on the 1st  February 2016 regarding the biocompatibility tests that are required. It also follows on from recent similar concerns from the Dutch regulatory body. The announcement however also confirms that no proven risk to the health of women with these implants has been demonstrated. If within the 12 month time frame insufficient evidence is presented then the implants will be withdrawn from the French market.

Obviously both of these announcements will be a cause of concern and anxiety for our patients. It should however, be noted that the numbers of ALCL cases remains very small, that Allergan is the market leader in the US and Europe with 60% of the market share, and that in many cases patients have had multiple implants inserted. It does appear that ALCL has only occurred when textured implants have been used.

As I noted in my previous communication, Breast implant related Anaplastic Large Cell Lymphoma (BI-ALCL) remains a rare condition that has been identified in 250 patients worldwide, with to date 8 deaths reported. It appears that there are at least 13 cases identified in the UK. It is estimated that 100 million women have had breast implant insertion worldwide. The incidence is thus, at the current time, 1:400,000, with a mortality of 1:12,500,000.

The condition presents usually with a late onset seroma, and is usually treated with capsulectomy alone, though some cases require chemotherapy. An algorithm for treatment has been developed in the US, under the team led by Mark Clemens. One of the causative factors appear to be macro-texturing.

Members are advised that all patients seeking breast augmentation should be informed about BI-ALCL, stressing that this is a very rare condition, which in most cases is readily treatable. All patients presenting with late onset seromas, or any breast lump, should be referred to a breast clinic. When a seroma is present aspiration to obtain CD-30/ALK levels is required to establish a diagnosis.

All cases in the UK should be recorded with the MHRA, with Joe O’Donohue, and Mark Clemens, in order that an accurate picture of this rare condition be established.

Yours sincerely 
Michael Cadier

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