Thank you.
I’m Sidney Wolfe. I’m a physician, and I’m the founder and senior advisor of Public Citizen Health Research Group.
Since the early days, we’ve been very concerned with the issue of implantable devices such as the breast implant, and in 1973, three years before the device law was passed, we testified at a House hearing which was considering new legislation.
Our testimony was directed at the deficits of the legislation, which did not have any kind of requirement for premarket testing for all implanted devices or all life-sustaining devices, life-supporting devices, ionization-emitting devices.
Despite our testimony, there was a lot of pressure from the device industry not to have this because it costs more to actually test things before you put them on the market.
And so the device industry, which had made a fortune—and we gave examples in the testimony of devices that had gotten people in trouble, killed, because they had not had premarket testing—they stood against it and it was never incorporated, and I’ll get back to that later.
In 1989, we appeared before this Panel on the topic of autoimmune disease and cited, by then, some very good evidence as to how the immune system would be stimulated by silicone.
Nir Kossovsky published a paper in 1983 on this, and we were very concerned, such that a year and a half later, we petitioned FDA to ban silicone gel breast implants.
This was in November of ‘91. And there was a moratorium placed on them not too long after that.
Just moving forward, in 2011, a week after the FDA made their announcements about ALCL, a very angry plastic surgeon called me up and he said, ‘You won’t believe what I’m going to tell you.’ So, I said, ‘What is it?’ I hear a lot of disbelief about things like that.
And he said there’s just been a video conference sponsored by ASPS1 and ASAPS2 urging their members not to really admit what ALCL was, and I’ll just read you a direct quote from the transcript that this guy sent us:
“Yes, it’s a clinically malignant tumor, but it has such a benign course that when we’re discussing ways to talk to the media, we decided that we would call this a condition. When we talk to the media, not a tumor, not a disease, and surely not malignancy.”
And they recommended the same thing be done to women. We got that letter sort of—the whole thing stopped, and it tells you the other side of these organizations.
Today’s conference raises the question by FDA of the fact that these postmarket studies are not being done reliably by some companies.
And I’ll end with this statement, which is, these post-approval studies to obtain information that should’ve been studied before, not after, approval, remind us why much more extensive mandatory pre approval animal and human testing on such permanently-implanted devices is necessary.
Otherwise, women or in other cases, both genders, are too often serving as guinea pigs.
(Applause)
[Open public comment given by Dr. Sidney Wolfe, Public Citizen Health Research Group, at the General and Plastic Surgery Devices Panel, FDA White Oak Campus, Building #31, Great Room, on March 26, 2019. The title of this article does not constitute part of the speaker’s presentation to the FDA Panel, and any hyperlinks within the text or text appearing in brackets were added for clarity or ease of use by editors.]
1 American Society of Plastic Surgeons
2 The Aesthetic Society; formerly, the American Society for Aesthetic Plastic Surgery