There is a gathering storm regarding breast implant associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and some people are speculating that after 20 years of development, the science underlying BIA-ALCL has raised the prospect of product liability litigation.
The first reference of a case of BIA-ALCL was in 1997 and by March 2003, four cases had been reported. There was mention of a possible link between the lymphoma and the implants but despite the emerging pattern, given the rareness of the occurrences, no further discussions were had. However, by 2009 15 cases of BIA-ALCL had been identified and researchers noted “the frequency of [lymphoma] in this clinical setting suggests a pathogenetic relationship with implants”.
In 2011 the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a medical device alert in the UK and a similar alert was issued by the Food and Drug Administration (FDA) in the US. The close proximity of the ALCL to the breast implants was considered noteworthy and both agencies warned of the very small but increased risk of women with breast implants developing the disease. Since then, 359 diagnoses of BIA-ALCL have been identified, with a specific type of implant becoming the focal point: the textured one.
It is now accepted that there appears to be a causal link between ALCL and implants but debate continues over how implants give rise to lymphoma – there are currently two competing theories. The first focuses upon the mechanical sheer stress between the textured surface of the implant and the surrounding tissue. Researchers have contemplated whether the friction between the texture and the tissue creates a capsule of scar tissue and as this grows, it has the ability to produce mutated cancerous cells. The second theory focuses on the biological contamination of implants prior to their insertion into a patient, with researchers saying the ‘mounting evidence clearly implicates a prominent and likely key role of implant bacteria/biofilm and associated host immune response’.
While the debate ensues, the number of reported cases of BIA-ALCL continues to rise. A study published in the January 2018 edition of JAMA Oncology put the risk of BIA-ALCL in a woman with implants to be one in 6,920. It is estimated that 35 million women worldwide have received breast implants. Based on the risk proposed by the recent study, we can expect to see over 5,000 cases of BIA-ALCL in the coming years. Whilst this is not good news, on the more positive side the medical literature suggests that prognosis is good with most women being cancer-free after removal of the implant and malignant tissue.
Elise Bevan, a solicitor in the product liability team at Pennington Manches LLP, considers whether any product liability litigation can now be expected: “Are there product liability claims to be brought on behalf of the women who have been diagnosed with BIA-ALCL? I think the answer is ‘maybe’. The scientific studies have suggested that bacteria play an important role in the development of BIA-ALCL. The textured implant appears to be the main culprit in the known cases of BIA-ALCL. Some scientists maintain that the textured surface makes the implant more susceptible to transporting high levels of bacteria inside the body. This raises the prospect of a potential design defect case. If such a case were to be brought, the claimant would need to point to a design flaw and show that with an alternative design (in this case the smooth implant) ALCL would not have developed. It goes without saying, however, that manufacturers will defend any claims robustly. I would anticipate that they will point to surgical contamination, rather than negligent design or manufacture, as the cause of the lymphoma.
“A problem that we are likely to see arising relates to the time limit for bringing a product liability claim. In most cases BIA-ALCL becomes apparent many years after the implants were placed. A May 2017 study reported the mean length of implantation in BIA-ALCL patients to be 10.8 years. This will have practical implications in that claims have to be brought within 10 years of the implant in question being put into circulation. Therefore, most of those who are affected will be out of time for bringing a claim. I think it is also significant that there has been no indication that textured implants will be removed from the market, despite the calls for them to be eliminated. If the textured implants were to be recalled, this would lead to all sorts of inferences being drawn. As things stand, I don’t think there is enough evidence to bring product liability claims but I strongly suspect that with new evidence and data my views on this will change.”