This transcript has been edited for clarity.
Hi. It's Dr Kathy Miller from Indiana University, back with you to think about how we handle rare risks of our therapies, treatments, and the medical things that we offer our patients. I'm thinking about this more generally, as the FDA has contemplated the additional information they need and the additional warnings that they might want to include for silicone-based breast implants.
This is another area where the pendulum has swung a bit back and forth, and we're learning more about the very rare but very real risk of high-grade anaplastic lymphomas occurring around silicone implants. This was first identified several years ago and we continue to learn more about it, but it remains clear that although the risk is very real, it is also very tiny.
That got me thinking about what other things we offer patients that have very rare but very real risks. Do we really inform patients adequately about those risks? More important, what level or severity of risk should lead to a requirement for full disclosure and fully informed consent?
Now, in no way do I mean to minimize the risk of anaplastic lymphoma in this situation, and I'm not arguing that patients should not be informed about this. However, I am arguing that it should be placed in context and that perhaps this should springboard us to a larger discussion about informed consent, risks, and when informed consent should be required.
This is not an issue unique to oncology and it's one that I don't think we have tackled particularly well as a medical society. My hope is not only that we get more information about the specific toxicity, but also that it leads to a larger discussion.
This is Dr Kathy Miller for Medscape.
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Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Kathy D. Miller. Let's Put Breast Implant Lymphoma Risk in Context - Medscape - Apr 09, 2019.
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