On 24th July 2019, Allergan announced a voluntary worldwide withdrawal of their BIOCELL textured implants. This was on foot of the United States Food and Drug Administration (FDA) notifying implant users of a link between the BIOCELL implant and anaplastic large cell lymphoma. Closer to home, the HSE began circulating this information in October 2019.
Both the FDA and HSE are maintaining that it is not necessary to remove or replace your implants unless you have symptoms. These symptoms are set out on the HSE website, as follows;
- swelling in the area of the implant;
- substantial change in the size of the affected breast which comes rapidly on over days or weeks;
- discomfort – the affected breast might feel tense or firm;
- a hard lump beside or near the implant;
- lumps in the armpit on the same side.
Whether you have suffered from the above symptoms or not, we understand that this recall may naturally cause serious distress and anxiety. There is a natural expectation that medical or pharmaceutical products, such as the BIOCELL implant, are safe for use. This naturally lends itself to Product Liability as governed by The Liability for Defective Products Acts 1991.
In order to bring a successful Tort action for a Defective Product, you must prove that a duty of care relationship existed, there was a breach of that duty of care and there is a link between breach of duty and damage caused. To ascertain who is responsible for a defective product in Tort, you must establish who owes the user a duty of care, i.e. the manufacturer, retailer, supplier or importer. The Civil Liability and Courts Act 2004 impose a two-year time limit on bringing a personal injury claim, while in Tort the statute of limitation stands at six years.
If you are a BIOCELL implant recipient, you may be entitled to compensation. Contact us one of our Solicitors today to discuss what options are open to you.