On 9 October 2019, the Health Service Executive released a statement advising that it had commenced informing some 8,000 women in Ireland who had received Allergan Biocell breast implants that an increased risk had been recognised between the use of these textured breast implants and a rare form of cancer of the immune system known as BIA-ALCL (Breast Implant Associated with Anaplastic Large Cell Lymphoma). Concerns regarding a potential association between this type of cancer and breast implants were first raised by the Food and Drug Administration (“FDA”) in the United States of America in January 2011 when some 34 potential cases of BIA-ALCL worldwide associated with breast implant products were reported. The medical device regulator in the UK, the Medicines Health and Regulatory Agency (“MHRA”), published an urgent field-safety notice on 19 December 2018 from the manufacturer of textured breast implants, Allergan (a Dublin-based medical products producer), advising that all textured breast implant products were being recalled and withdrawn from further use. By July 2019, the FDA had identified some 573 cases of BIA-ALCL associated with breast implants, of which 481 were related to the use of Allergan Biocell textured breast implants.
Whilst the risk of BIA-ALCL is low, women with breast implants, particularly textured breast implants, should be alert for symptoms of this disease which may include:
- Swelling of the area around the implant;
- Changes in the size of the affected breast which often develop rapidly over a short period of a few weeks;
- Collection of fluid in the affected breast;
- A lump or swollen gland present close to the breast or in the armpit.
Should you experience any such symptoms, you should contact your surgeon or general practitioner for advice.
Ivor Fitzpatrick & Company are currently investigating potential legal claims associated with the use of Allegan textured breast implants in patients who were not warned of the serious potential adverse side-effects or increased risks associated with the use of these products. Should you have concerns regarding adverse side-effects from these or similar breast implants, it is important for you to seek legal advice as soon as possible. Ivor Fitzpatrick & Company have a dedicated team of experienced and innovative lawyers who are skilled in the investigation and prosecution of legal claims for the recovery of compensation in surgical cases associated with the use of defective medical products.