Tuesday, March 20, 2007

The Ghost of the Silicone Implants Returns

No, not poltergeists: Breast implants filled with silicone gel.
For women who've had a bad experience with implants, that news may be little better than a visit from an angry apparition. There are women around the world who hold silicone breast implants responsible for their autoimmune disease or cancer. These women must be shaking their heads in amazement: Why are silicone implants available again?

The way this question is answered says a lot about the role you think the government should play in your healthcare. Is it the role of government to minimize all danger, or is it their role to make sure we are aware of dangers, and then leave the final decision to us, the individuals?
Silicone implants still aren't "safe," depending on how you define that word. Even the Mentor company, which manufactures saline and silicone implants, acknowledges that implants can cause some health complications. These may include "hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery," says spokesperson Melissa Vayra. And the FDA is on record saying that a woman getting breast implants needs to understand that there is a significant chance she will need additional breast implant surgery in the future. Ruptured implants can go undetected and silicone can migrate in the body, even into organs. This escaped silicone can form lumps, and some of it may be impossible to remove from the body.

Sounds nasty. But none of these side effects, in isolation, represent a grave threat to a woman's health. On the question of silicone implants' role in causing autoimmune disease or cancer, the prosthetic devices fare better: the large majority of studies and trials conducted since silicone implants were taken off the open market back in 1992 have failed to show a link between silicone implants and the development of these serious diseases. While it's impossible to say that they do not have some still-undetected part to play in ill health, to quote the Susan G. Komen Breast Cancer Foundation (SGKBCF), "the overwhelming body of evidence does not support the existence of a link between silicone breast implants and major diseases of the body..."
If you believe that the government's role in healthcare includes protecting us from ourselves, you may want silicone breast implants to remain off the market. According to the SGKBCF, only 20-percent of breast implants are related to medical need (for example, breast reconstruction). Multiple implant surgeries, pain, loss of sensation and migrating silicone may sound like a high price to pay for a fundamentally cosmetic procedure.

But the question is, do you - or the government - have the right to make that choice for women who are willing to pay the price? The substantiated hazards of silicone implants are well-documented; information on the risks is available. And many women, clearly, think the risks are worth it.
by Kristen Kelly

1 comment:

Dr. Rob Oliver Jr. said...

While I think you have a handle on the philosophic issue about the role of organizations like the FDA and non-essential surgery (breast augmentation and reconstruction with implants in this case), I think you are a little off re. some of the risk of these devices.

As you point out, there is broad international consensus that silicone implants are not correlated with increased rates of autoimmune phenomena or cancer. Some of what you describe in terms of the potential for migration of ruptured silicone gel is not particularly relevant for modern devices.

You rarely find signifigant extracapsule gel movement anymore as the fillers have gotten progressively more cohesive (semi-solid) and forthcoming (but already in use world-wide) "form-stable" implants largely eliminate any potential for gel migration at all.

Reoperation rates have been unacceptably high in previous studies, but we clearly know that most of these can be avoided by making better choices re. implant size, surgical technique, and the move away from saline implants (which are heavier for similar volumes). Several large recent series have reoperation rates in the low single digits years out from surgery in the Plastic Surgery literature.