Allergan pulls breast implants after link to rare cancer
Allergan has followed through on an FDA request to carry out a worldwide recall of textured breast implant products after the agency said they were linked to a rare cancer.
The US regulator issued an alert yesterday saying the implants elevated the risk of anaplastic large cell lymphoma (ALCL), a rare form of non-Hodgkin’s lymphoma (NHL) that is usually found in children and young adults.
In its alert, it said that while the incidence of ALCL linked to the implants “appeared to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action.”
Allergan – which is set to be acquired by AbbVie in a $63 billion deal announced last month – revealed in its fourth-quarter 2018 results statement at the end of January that it had implemented a recall of textured breast implants “in certain international markets.”
The company sold almost $400 million-worth of breast implant products last year, a fall of around 2% on 2017’s tally, and that represents around 2.5% of Allergan’s near-$16 billion in group 2018 sales. That means the impact on the company directly will be minimal, although the recall does raise the spectre of potential liability suits down the line for Allergan /AbbVie.
The affected product range – sold under the Biocell banner – include Natrelle, Natrelle Inspira and Natrelle 410 saline and silicone implants, as well as Natrelle tissue expanders used by patients prior to breast augmentation or reconstruction.
In a statement, Allergan said that the medical advice is not to remove or replace the textured breast implants in women who show no signs of ALCL. It’s estimated that the implants have been used in hundreds of thousands of women worldwide, and much more commonly in Europe than in the US.
It also warned that “effective immediately, healthcare providers should no longer implant new Biocell textured breast implants and tissue expanders and unused products should be returned to Allergan.”
The FDA says it started to monitor the issue since it first identified a possible link between textured breast implants and ALCL in 2011. In that same year, it communicated its concerns to patients and healthcare providers, but says it has now firmed up the warnings based on “new data.”
On its website, the regulator describes 573 cases of breast implant-associated ALCL or BIA-ALCL, including 33 deaths, which it says is an increase of 116 cases and 24 deaths since its last update earlier this year. Of the total, 481 cases have been seen in patients who received an Allergan product.
The main symptoms of BIA-ALCL are swelling or pain in the area of the implant, according to the agency.
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