Posts Tagged saline filled implants
I have been flamed a bit online over my stance on breast implant size. Some women simply cannot go to the larger sizes without an undue risk of complications. That does not mean I simply do not offer surgery to women seeking larger sizes. Here’s a woman I operated twice over twelve years to give her the bust she desired. The first time the 750 cc implants she ultimately received would not have fit in there (her first operation was with 350 cc implants.). She has no rippling and no pain and these are saline-filled implants. They fit her form pretty well and most importantly she is happy.
John Di Saia MD
PIP implant makers did try to get FDA approval in the year 2000:
PIP was one of three companies that submitted an application, which came under review of a panel of outside advisors to the FDA in March 2000. At the time, PIP said it had already sold 35,000 of its pre-filled saline implants in the U.S., and that it was the third-largest manufacturer of breast implants in the world.
But the panel recommended that the FDA reject PIP’s application. Panelists said at the time they were not reassured by PIP’s data, and that the company’s clinical trials did not include enough patients that were followed for an adequate time to truly evaluate the device’s risks.
‘Like it or not, we have a regulatory threshold which is probably higher or at least different than it is elsewhere in the world, and I think in order to get your product approved, you’re just going to have to bite your tongue and meet that threshold.’
PIP saline implants had a high rupture rate as it became known in plastic surgery circles. The PIP saline implant line was available in the US for a short period of time ten or fifteen years ago.
Conservative surgeons like myself used very few of them and warned patients who requested them of their less than stellar reputation. I had one such patient who I remember had a rupture not-so-long after insisting upon having PIP saline filled implants.
She had felt PIP salines at another surgeon’s office and decided that these implants were for her. I actually had her sign a statement that I was recommending a US made implant with which I had more experience.
At least when saline implants rupture it is only saline (and a flat breast) with which the patient must be concerned. PIP silicone implants apparently had low grade silicone gel within them. This is a bit scarier.
I simply recommend any patient with PIP implants have them removed. It is a shame that not all women keep track of the implants they have had though.
John Di Saia MD
Roughly 30 years ago, Mariel Hemingway, 49, had breast augmentation surgery that jeopardized her health. Now the actress wants to warn others of the potential dangers of plastic surgery. “I actually had silicone in my blood,” said Mariel. “So I did hyperbaric oxygen treatment to turn the silicone into silicone citrate so it could pass, but it took a long time to get that out of my system.”
Entertainers can have kinda unusual ideas about science. Apparently Mariel Hemingway is no exception.
As we have discussed here before, silicone gel breast implants (especially older generation units implanted prior to cohesive gel models) have a tendency to leach silicone into the body. The body reacts to this gel and that reaction can create problems over the long term most often hardening of the breasts and severe capsule formation (capsular contracture.) While I agree that saline-filled implants are safer, some women still want silicone gel implants. I encourage them to get the cohesive gel variety (gummy bear breast implants) as they should have less of this leeching going on, but the jury is still out on the nature of tissue reactions with these newer silicone implants. Will they be any less severe than those of their less viscous predecessors? For women less risk tolerant, this Orange County plastic surgeon recommends saline-filled implants.
On Ms Hemingway’s suggestion that hyperbaric oxygen might help the body rid itself of silicone gel, I would be more prone to recommend a thorough removal of the implants and their scar capsules. While silicone gel can travel to distant sites, this is far more rare than concentration in the local tissues. Hyperbaric oxygen is not a proven treatment for silicone removal.
Scar capsules of older silicone implants (older meaning non cohesive gel units) can look like something from a Sigourney Weaver flick. If you have older silicone implants, my recommendation is usually to remove and/or replace them and certainly have the capsules removed as completely as possible in the process. The safe replacement interval for cohesive gel units has yet to be determined, but ten years would be a reasonable guess-ti-mate.
John Di Saia MD