So then implants took off and there were multiple types of implants. The type of envelope that they were in, the silicone formula for the internal gel saline implants came around in about the late 1960s. But they seemed to have a lot problems originally with high leakage from the valve because you had to fill them in the operating room and they did slosh quite a bit.
There was an implant called the Ivalon sponge, which was like a big wad of polyurethane foam rubber that would be put in. I had the opportunity to take several of those out very early in my practice and they were absolutely awful. If you ever go online and you see pictures of implants that they swear have mold and cruddy things coming out of them, I think those were probably the very old Ivalon sponges.
In 1976, the FDA finally decided to regulate the safety of medical apparatuses, and silicone breast implants fell under that but were given a grandfather out because they’d been in use for about 15 years at that point.
In 1977, the first lawsuits started because of increasing firmness around the implants, because of rupture.
And go forward, go forward, go forward: 1988. Now the implants are a Class III category, which means they have to prove their safety. Plastic surgeons and implant manufacturers realized that they had exceedingly little data in terms of safety in the human female breast.
Of course, the flip side to that is they didn’t have data that it wasn’t safe. What we knew at the time and still continue to hold out, as I would say, probably the two most negative things about implants is that they will not last forever, and women may, and frequently do, develop hard scarring around the implant, what’s called a capsular contracture.
By 1990, when the episode with Connie Chung came out, then lawsuits were filed just all over the country; actually really probably all over the world, eventually leading to the collapse of Dow Corning, and many lawyers got very rich in this time.
Unfortunately, in the courts, what was being offered up as expert testimony is now widely considered to be junk science. Plaintiff’s attorneys would say just about anything, Dow Corning kept settling, settling, settling, and then eventually there was a large settlement and all of the Dow Corning implants went away.
Also at that time, an implant that was in significant use was called the polyurethane implant, or it was manufactured as Même or Replicon. I used this a lot. It had an external coating that was textured, and when you would put the implant in, the body would integrate into the shell of the implant.
So, we’ll go back just a little bit to anatomy. When an implant is placed into the breast, either under the breast or under the muscle, your body is going to make a little layer of scar tissue around it.
That’s called the capsule. Everybody makes a capsule. As long as you have a functioning immune system, you’re going to make a capsule.
What happens to many breast implants, though, is as they fail, the silicone will begin to leak through the outer envelope. It’s captured by the scar tissue around it. That sets up the body’s immune response, and now you start getting more and more firmness as the body sends more scar tissue in.
And the old implants that we would take out, because there were significant incidents of silicone leakage and rupture, the inside of the capsule (remember that’s the shell around the implant) would really look like the inside of a bad water pipe. It would just be plainly calcified.
And of course, if that started to develop and the implant hadn’t ruptured by the time your nice smooth implant is rubbing on this calcified shell internally, then of course it’s going to completely rupture or bust.
So around 1992 or 1993, silicone implants were only approved for use in women who needed reconstruction, which I always thought was rather oxymoronic.
Basically, you’re saying “if you’re a healthy woman, we don’t know if it’s safe enough for you to have, but if you’re a woman with breast cancer, well, what the heck? You’ve already got breast cancer. I guess you can get a silicone implant.” That just always absolutely rubbed me the wrong way.