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Allergan Implants: The Story so Far….

Product liability solicitor, Sarah Moore, discusses the developments that have happened since French regulator ANSM recommended a permanent ban on the sale of Allergan implants.

Surgery
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Sarah Moore specialises in product liability and claims for groups of people who have suffered an injury because of unsafe products. She has written a number of articles on topics such as drug regulation, cigarette packaging and food safety.

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 due to possible links with the rare cancer BIA-ALCL
 

Since then we have been contacted by more than 280 women who have received the Allergan implants and who are now concerned about their future health, nine of that group have been diagnosed with the rare cancer known as breast implant associated anaplastic large cell lymphoma (BIA-ALCL). We are currently investigating bringing a group claim on behalf of these women against the manufacturer of their implants Allergan and/or the private clinics responsible for their implant procedures
 

As of today’s date, the MHRA continues to advise women with Allergan textured breast implants that:
 

  1. There is currently no evidence of an increased risk to patients
  2. There is no need for women to opt for removal
  3. There is no need for any additional clinical follow up
  4. They are monitoring the situation closely


That advice has not been updated since Christmas Eve 2018.

In that context, you’d be forgiven for thinking that there have been no significant developments in relation to breast implants generally and Allergan implants in particular, over the last six months.

 

However, this is far from the reality, as the brief Allergan chronology sets out below. International regulators are looking with renewed energy at the safety of breast implants in general, with a focus on BIA-ALCL and Allergan implants in particular.

 

2 April 2019: French Ban: The French regulatory agency (the ANSM) announced that following an expert panel hearing during February 2019 a decision had been made to ‘prohibit the placing on the market, distribution, advertising and use of macro-textured breast implants and polyurethane breast implants’. Manufacturers were advised to ‘proceed with their withdrawal in view of the rare but serious danger that their implantation is likely to constitute’.

The ban included textured implants made by:

 

  • Allergan
  • Ploytech
  • Nagor
  • Eurosilicone
  • Arion
  • Sebbin

 

This was followed by a European-wide ban on the use of Allergan Biocell implants, including in the UK

 

4 April 2019: Canadian Ban: Health Canada announced their decision to suspend the licences for Allergan’s Biocell implants as a precautionary measure. Health Canada cited the fact that of 28 BIA ALCL cases confirmed in Canada 86% were linked with Allergan Biocell implants.

 

9 April 2019: Australian Continued Monitoring: The TGA, the Australian regulator decided not to ban textured implants at this stage, but instead require all manufacturers to provide in depth data on how many implants have been supplied as well as physical samples of the products within 10 days of the announcement.

 

2 May 2019: US FDA Black Box Warning: The US regulator, the FDA, made the decision not to ban textured implants, but rather to impose stricter reporting on manufacturers and to consider recommending that manufacturers add a ‘black box’ warning to textured implants warning patients of the link between textured breast implants and ALCL.

 

28 May 2019: Allergan voluntary recall in Canada: Allergan announces it will voluntarily recall and stop the sale of its Biocell textured breast implants in Canada, following the suspension of its licences in April

 

Against this backdrop - where does the MHRA’s current guidance leave women in the UK with Allergan, or other textured breast implants?

 

The MHRA states that one of its core responsibilities is ‘helping to educate the public…about the risks and benefits of…medical devices’. However, as it stands the MHRA’s published guidance does not require surgeons or manufacturers to proactively contact women with Allergan breast implants to alert them to the risk of developing BIA-ALCL. Despite this, we think it is important that women are advised to regularly monitor their breasts for the signs and symptoms of BIA ALCL and make sure they get checked out if they have any concerns. Early treatment is key to a good prognosis.

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