The Allergan breast implant saga continues to drag on, leaving both medical professionals and patients in limbo and fearing that they may be vulnerable to a rare form of cancer known as Anaplastic Large Cell Lymphoma (BIA-ALCL).
Allergan Inc. issued a worldwide recall of textured models of their bio cell breast implants last week after an FDA (U.S. Food and Drug Administration) investigation concluded that breast implants with a textured surface account for a disproportionate amount of the large cell lymphoma cases. This represented a U-Turn from their previous position where they were of the view that these products did not pose any risk and should be kept on the market.
Similarly, the Medicines and Healthcare Regulatory Agency (MHRA) maintained their position until recently that there was no evidence of an increased risk to patients and there was no need for women to have the implants removed or seek clinical help. This position was maintained by the MHRA since December 2018 and appears to ignore clear evidence that has been established in the interim linking the Allergan implant to Anaplastic Large Cell Lymphoma.
The French and Canadian health authorities imposed a ban on the implants as early as April 2019, this was as a result of clinical research which demonstrated a clear link between the implant and the rare form of cancer.
The MHRA advice did not require surgeons or manufacturers to contact women with Allergan implants and inform them of any potential risks. Therefore, the recent news of a global recall of the implants has understandably caused significant worry and distress.
While research into the dangers of the Allergan implant is ongoing, the FDA’s investigation did conclude that 80% of the 570 confirmed cases of Anaplastic Large Cell Lymphoma were directly linked to women who had the textured Allergan Implant.
The true extent of the women affected by the rare cancer remains unclear. However, what is clear is that there has been a systematic failure by the manufacturers, regulatory bodies and medical professionals to properly investigate the risks associated with this product.
Many women in the UK and Ireland are now preparing to make a claim for compensation against the manufacturer, Allergan Inc. As a manufacturer of goods for public consumption Allergan would have been obligated to take steps to ensure that the product did not pose a risk to the public or to adequately warn people of any potential risks. If it can be proved that Allergan failed to take appropriate steps and someone who has used the product has suffered a loss, then they will be able to make a successful claim against the manufacturer.
In a scenario where someone intends to make a claim against the health care regulatory bodies or a particular medical institution or individual then the criteria for making a claim will be slightly different. Women who have the implants and have been diagnosed with cancer or suffered any other form of loss may believe that this could have been avoided if they received an adequate warning from medical professionals. A case of this nature may require a claim to be taken against both the medical institution and regulatory or advisory body in order to firmly establish negligence.
While the fallout continues over the dangers associated with the Allergan implant, thousands of women in the UK and Ireland have been left in limbo. Many are understandably anxious to have the implants removed, even when they are not experiencing any negative symptoms. This is another example of the healthcare treatment provided to women in the UK and Ireland falling well below an acceptable standard.
Our medical negligence department at PA Duffy and Company are vastly experienced in dealing with claims relating to defective implants. If you have been affected by this scandal our expert solicitors would be happy to meet you and discuss your options for taking legal action.