Solicitors considering potential group claim in relation to Allergan breast implants
The consumer law and product liability team at Leigh Day has been contacted by over 200 women who have received the Allergan implants who are now concerned about their future health, six of whom have been diagnosed with the rare cancer known as breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
Posted on 11 March 2019
Leigh Day is investigating a potential civil claim on behalf of the women who allege they were implanted with a product that carried an increased risk of cancer of which they were not adequately warned.
In an article in The Guardian today it is reported that according to figures collected by plastic surgeons there have been least 615 cases of the disease associated with breast implants and 16 deaths around the world. There have been 45 confirmed cases of the rare cancer ALCL in the UK and it has been linked to one death.
On 8 February 2019 the French regulator Agence Nationale de Securitie du Medicament (ANSM) recommended a permanent ban on the sale of Allergan textured breast implants across Europe.
The French regulator initially announced the temporary suspension of the Allergan CE mark during December 2018. At a public hearing in Paris in February the expert committee referenced concerns about the adverse health effects associated with breast implants, including a rare form of cancer known as BI-ALCL which a growing body of research now indicates is linked with Allergan implants. After 2 days of testimony the ANSM called for a ban of Allergan textured breast implants.
The UK regulator, the MHRA, who is acting as lead co-ordinator to make sure Allergan takes a consistent EU-wide approach, has yet to respond to the recommendations made by the French expert committee.
At the moment advice from the MHRA, is that there is currently no evidence of an increased risk to patients and there is no need for people who have Allergan breast implants to get them removed or have any additional clinical follow-up. The MHRA say they are monitoring the situation closely and will provide updates as necessary. However the US Food and Drug Administration has now had more than 400 reports about patients who developed ALCL after having a breast implant, including nine who died.
In a statement to the Guardian, Allergan said the company is committed to strict adherence to all regulatory requirements and rigorous scientific evidence.
Our client Irene Kennedy, 49, who had the Allergan implants and has been diagnosed with ALCL, told the Guardian: “I hadn’t heard of it, I didn’t know anything about it at all, it’s very scary. If someone said ‘By the way, you could get a cancer’ your ears would prick up and it would be more of a thoughtful process you’d go through.”
Zahra Nanji, solicitor at law firm Leigh Day who is investigating a potential group claim on behalf of more than 200 women who have received the Allergan implants, said:
“We have been contacted by hundreds of women who are now extremely worried about the potential risk of cancer from Allergan implants and feel angry that they were not given more information about the risks from their clinics. Many have said that had they known the risks they would not have gone through with the operation.
“Deciding to have a medical device put into the body, whether for aesthetic, emotional or health reasons is a serious decision and it is crucial that patients are made aware of all the relevant information and risks associated with the medical device in order for them to be able to make an informed decision.
“We urge the MHRA to take stronger action in relation to textured implants manufactured by Allergan, as per the recommendation of French Authorities, to make sure more women are not put at risk by having these products implanted.”