Health committee  I'm not the one who decides that, but clearly my statement is always this: If we are continuing to give breast implants to healthy people, they should be well informed. Preferably, I would say, “You are a guinea pig, and if you want to participate in this study, yes, you're allowed.”

Health committee  Yes.

Health committee  Never.

Health committee  I tried to calculate that. From the other experiments in other countries, it's calculated that about 25% of the patients with breast implants have issues that might be due to the implants.

Health committee  It's an extremely high risk.

Health committee  The FDA recommended trials when the ban was lifted. However, these trials were not done and were not done properly. We had an FDA meeting, I think, three or four years ago where I was also a witness. There, many patients came forward and said they participated in these trials, but as soon as they developed complications, they were sent out of the trial because they had complications.

Health committee  It was Mentor and Allergan.

Health committee  I'm sorry...?

Health committee  Yes, those are the challenges with breast implants and mammograms. Breast implants, especially the older breast implants, are leaking, and if you have the pressure of a mammogram it can cause more leakage and you can rupture the breast implant. The FDA warns against this, and I personally also warn my patients.

Health committee  Yes, but I see it the other way. Many patients tell me that their problems actually start after the mammogram, so I'm not sure that radiologists see that.

Health committee  For ALCL, it's clear that if you combine pathology data with the breast implant registry, it would be easy to see exactly which breast implant was used. For instance, it's been considered that it's mostly a macrotextured issue, because an allergen was blamed for that. However, the Korea scandal in 2021 was actually that microtextured implants also can cause ALCL.

Health committee  Many publications on breast implants are heavily sponsored by the industry. I must confess that I, myself, was also offered a grant from the industry, but I would have had to sign an agreement that I could never publish anything without their consent. I refused that. That's not ethical.

Health committee  Of course, first of all, it's a recall registry, but you can implement PROMs—patient reports of outcome measurements—on the questionnaires that patients have. For instance, in the Netherlands, they are currently doing that. They are registering all kinds of complaints from patients to see how often breast implant illness occurs, how often autoimmune diseases occur and how often ALCL occurs.

Health committee  There are a few things. Regarding the opt-out system, the dataset that can be used should be the same as the one in Australia and the Netherlands, but there should also be a PROMs dataset. That's patient-reported outcome measures. Compliance with the mandatory registry could be an issue.

Health committee  Thank you, Mr. Chairman. My name is Jan Willem Cohen Tervaert. I'm a professor of medicine at the University of Alberta and also emeritus professor in medicine and immunology of Maastricht University in the Netherlands. Currently I'm also a member of the expert panel on medical devices of the European community.