World-wide Recall of Biocell Textured Breast Implants and Tissue Expanders due to link with Breast Implant associated Anaplastic large-cell Lymphoma (BIA-ALCL)
What is BIA-ALCL?
BIA-ALCL is a rare and highly treatable type of T-cell non-Hodgkin lymphoma that can develop around breast implants. BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. This is a cancer of the immune system, not a type of breast cancer. The current lifetime risk of BIA-ALCL is estimated to be 1:2,207 – 1:86,029 for women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades.
Typically, the cancer cells are found near the scar tissue and fluid near the implant but in rare cases they can spread.
More than 50 people have been diagnosed with the condition in the UK and hundreds more worldwide. Cases have occurred between 3-14 years after surgery. BIA-ALCL can be cured successfully if treated early with surgery, most often without the need for radiotherapy and chemotherapy. Following a request from the US Food and Drug Administration (FDA), Allergan issued a global recall of Biocell textured breast implants and Tissue Expanders on July 24 2019. 38 countries have now recalled this implant and it would not be surprising if a number of clinical negligence claims follow. Although this could easily be categorised as solely a product or manufacturing issue, the surgeon or the clinic could also be criticised for using a product that is now considered unsafe in the UK, the Medicines and Heathcare Products Regulatory Agency (MHRA) is currently collecting data on women affected. They issued a joint statement with several of the UK’s leading surgical bodies in July 2019 advising that it is “essential” that surgeons make all patients considering a breast implant for reconstructive or cosmetic purposes fully aware of the potential risks.
What could this mean for claims against surgeons?
There may well be some litigation on the horizon involving patients affected by BIA-ALCL due to these types of implant. We anticipate that the majority of such claims would be “product liability” claims directed against the manufacturers only.
However, this issue could give rise to claims against surgeons too, so Incision members who have ever used these types of implants, or are still using them, will need to be alerted.
Since the MHRA is still collecting data, it is too early to say whether patients will ever be able to argue that no reasonable surgeon would have recommended or used these implants. However, surgeons should keep abreast of news, because if and when a recommendation is made that (say) their use should be discontinued, a surgeon who continued to use these implants subsequently would have great difficulty defending a resulting claim.
The more immediate issue for surgeons is probably obtaining informed consent from their patients. As all surgeons should know, following the Montgomery decision 2015, obtaining informed consent based on what is “material” to that individual patient is key to avoiding claims arising from even non-negligent complications. Following the MHRA statement of July 2019, advice on these potential risks probably should have been part of a breast surgeon’s fully-informed consent procedure from that date onwards, and possibly even earlier as concerns about these implants started to be reported although to our knowledge, at least at the time of writing, there has not been a decided court case on this specific point). Surgeons should make sure that their current consenting process includes a discussion of the risk of BIA-ALCL with textured implants, and that the discussion is well documented in the notes. It would also be prudent to check back to around July 2019 to see whether there are any patients who received a textured implant without first having been warned of these potential risks.
What does this mean for your insurance?
As always, informing (“notifying”) your insurers about either “Claims” or “Circumstances” that could lead to Claims is key to making sure you are covered for these issues, and also that you have prompt medico-legal guidance and legal advice at the point where it will have most impact in protecting your position.
Therefore if you notice that you have patients who received a textured implant after the MHRA statement of July 2019, without express warning of and consent to those potential risks, then it would be prudent to call the medico-legal helpline so that we can help you make a precautionary notification to your insurers if necessary.
Similarly, if any patients contact you about their textured implants and allege or imply that they blame you for recommending them (regardless of whether their complaint has any merit), then you should call the medico-legal helpline so that we can provide guidance on how to manage that patient’s complaint, and help you make a precautionary notification to your insurers if necessary.
We will be on hand to help you if any of your patients are unlucky enough to be diagnosed with BIA-ALCL, or if any patient requests their records in relation to these types of breast implants.