- Why were silicone breast implants banned in the first place?
- What changed to get them re-approved?
The fact is that prior to banning silicone breast implants for 14 years then re-approving them again for use in 2006, they never were determined unequivocally to be unsafe. Yes there were ruptures and yes people were claiming to have become sickened as a result, but a solid connection between the two was just never made.
So there was two conditions that the FDA made contingent on, or in effect tied to the approval of them, and one is that a newer more stronger multi-layered plastic casing be used to contain the silicone. The second is that both companies, (Inamed & Mentor), that manufacture silicone breast implants must each finance, and conduct 10 year post operative studies of some 40,000 patients.
So why the FDA flip-flop on this issue in the first place, and is there any perceived risk? Also if you do go with silicone breast implants, is it possible that you will end becoming part of this study even if you don’t want to? The simple answer to the first question regarding why the FDA has doubled back on them is that it was mass hysteria that led them to be banned in the first place.
It all began when a relatively small number women began to come forward with ruptured implants, claiming that they were made sick as a result. The problem though was the sicknesses that they were alleging to have had tended to be difficult to substantiate because they were for the most part claiming to have problems like autoimmune disorders, chronic fatigue, etc.
So it really was a relatively minor issue comparatively speaking until it made it onto the national news, and then all hell broke loose. Suddenly it seemed as though just about every person who had ever had any type of silicone implant spring a leak was claiming that it had ruined their life, and of course hordes of attorneys came running to answer the call.
Then to make matters worse, the makers of silicone breast implants went ahead and paid off some of the more pathetic of the initial claimants that were the focus of some of the more sensational news reports, and that was akin to pouring gasoline on a fire. People then smelled easy money, and the result was that whole thing took on a life of its own.
Multi-million dollar lawsuits were filed and not to be left out, now even women who’s silicone breast implants hadn’t ruptured were piling on top of the band wagon. So then what was it that they were suing for? Why the stress of worrying that theirs might rupture, plus the fact that they had to have their implants that were now collectively viewed as ticking time-bombs removed.
In the end though, it was the massive numbers of people alleging to have been damaged that was the key to sorting the whole mess out because now the larger numbers were there that were needed to conduct comprehensive studies. So what did the studies determine after all the studies were done, and data was compiled, and examined?
What was found was that for the most part, what they had was a bunch of women complaining of things like headaches, that they were tired, and that “they just didn’t feel good”. Does that sound familiar? Also with regards to the more serious problems like breast cancers and autoimmune disorders, there was no change from statistical averages taken from the general population.
All of this took years to wind it’s course, but in the end all the attorneys had to go home empty handed, and the two makers of silicone breast implants were left with banned products that through it all people once again wanted. You see the fact is that silicone delivers the best results, and after all the dust had settled, intelligent people were seeing it for what it was. “A big legal money grab”.
Just the same though, the FDA just doesn’t like to ban things then clear them for market again for one darn good reason, and that is that it means that they were wrong, and they don’t like to be seen as being wrong. So then how to get around it, and bring silicone breast implants back in such a way that has the FDA being right?
What they did was to develop a new multi-layered casing which did away with risk of leakage, and they also couched the whole re-approval in with this 10 year 40,000 person study. In this way while the FDA was once again approving them, it was in effect doing so all wrapped around a study and that’s what the FDA does.
So then what has this study determined so far, and and do you have to take part in it if you get silicone breast implants? The answer to that is no you can’t be forced to take part in any medical research program although your doctor may provide data in a generalized form. That is that your records can’t be used, but general statistics regarding patients may submitted.
As far as the study findings are concerned though, a few things have turned up both on the positive, and the negative end. On the positive end, the new casing are proving to be the answer to the problems of leakage, and also alleged connections to conditions like breast cancer, immune disorders are being even more thoroughly debunked. They simply bring no greater risk.
At the same time though some minor problems like generalized area tissue hardening, pain, and loss of nipple sensitivity have been detected, and in fact connected to the casings. Even so, it’s the texture of outer surface of the silicone breast implants that was determined to be the cause, and the solution has been found in the form of new outer surface texture designs that are currently being tested.
