Hooray Fda !

**grace angel** · 04-13-2005, 06:57 PM

I'd like to applaud the very slim victory of continuing the moretorium on silicone breast implants being available in the states. The FDA has known for over 40years that exposure to silicone gel makes women sick. Those who complain about choice issues can either choose saline implants in the states or travel to other countries where silicone implants are available. Its about time a governmental agency woke up and actually listened to the testimony of some very sickly women who were poisoned due to the negligence of the FDA not regulating silicone implants as medical devices. :cheers:

**Bev Heishman** · 04-13-2005, 07:55 PM

My understanding though is that silicone implants are still used for many breast cancer survivors. They also found & said that this type did not pose much of a threat. Face it. Let a person decide and let them deal with the decision. It is their personal choice. Everything has risks and benefits and people decide what they want when they sign informed consent. I am to the point I have no pity and I would include myself on such a choice.

There is freedom of choice and the effects the individual makes should not fall back on a physician. If there is truly a problem, not related to physician ineptitude, that is the patients fault. If you signed off, live with it. I have known 3 people who had bypass stomach surgery to loose weight. They went for the risks fully apprised. 2 of them died. They chose there destiny.

**coda** · 04-14-2005, 09:50 AM

Very well said, Bev. Informed consent is a wonderful way to run a country, people get what they want and if it kills them (or sickens them or what not) they knew the risks ahead of time.

Incidentally the FDA review panel in question vetted the sale of a competitors silicone oil implants the next day (4/13/05) though the FDA is not expected to act on the recommendation without first requesting further data.

**Pete Hanlin** · 04-15-2005, 12:05 AM

I'm not sure the case for silicone actually causing illness has been substantiated. I could be wrong, but I thought the largest studies of women with silicone breast implants found that incidences of the most commonly suspected related diseases (lupus, etc.) were pretty much the same in both the silicone implant and non-implant groups.

If there is medical research to the contrary, I'd honestly like to know about it.

**karen** · 04-15-2005, 08:27 AM

If a woman knows the risks involved and wants to choose silcone, why should she not be able to. In the US currently if you meet certain specifications you can qualify for silicone so the logic of not approving it escapes me. Outside the US there are many women with silicone who are very happy. Mentors rupture data was better than Inameds so that is why they made it through the gauntlet. I am not belittling the stories of women who feel their health issues are directly related but if I know the risks involved (and a doctor would make sure I did to cover his own butt) and want silicone then it's on me if I get sick. Today's implants with cohesive gel and the like are much less likely to rupture anyway...

**shanbaum** · 04-15-2005, 10:26 AM

Originally Posted by karen

If a woman knows the risks involved and wants to choose silcone, why should she not be able to. In the US currently if you meet certain specifications you can qualify for silicone so the logic of not approving it escapes me. Outside the US there are many women with silicone who are very happy. Mentors rupture data was better than Inameds so that is why they made it through the gauntlet. I am not belittling the stories of women who feel their health issues are directly related but if I know the risks involved (and a doctor would make sure I did to cover his own butt) and want silicone then it's on me if I get sick. Today's implants with cohesive gel and the like are much less likely to rupture anyway...

Thanks for keeping us abreast of this sensitive matter.