The editorial from today's Chicago Tribune , reflecting on the treatment of breast implants here in the USA.
The whole episode was a case study in the folly of policymaking by anecdote..... So why did it take a decade and a half for the FDA to let these implants back on the market? One reason is government regulators don't like admitting they were wrong. Another is that they prefer to err on the side of excessive caution. No one will get sick from an operation she is not allowed to have, which means no bureaucrat will be blamed for the illness.
Another comment from the NewsBusters blog titled "Deflating Hysteria: Implant Scare of Early '90s Had No Merit"
From the Saginaw (MI) News "Greed, implants and iffy science"
The FDA's approval this month still doesn't address the shortcomings of a legal system that steamrolled over science and caused manufacturers to suspend or quit marketing of silicone based medical devices. Its anyone's guess how many lives and health hardship that cost....It's a travesty of our product liability system that it took so long and cost so much to give women the choice. The only big winners in this legal-medical saga were the lawyers. (emphasis mine)
From the Business & Media Institute " article "Unhealthy Bias in Implant Stories, Then and Now" which focuses on the media treatment from the early 1990's culminated in the infamous Connie Chung hit piece on "48 Hours"
From AEI comes "Two Cheers for the FDA - The recent decision to allow silicone breast implants was a sadly unusual victory of evidence over fear for the agency."
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4 comments:
Yhere is nothing to recover from, for some reason people like to assume the FDA gave there full approval for implants being safe this is not so they have strict conditions they have also put it as a high risk the highest it can be put. Also Dow has not been exonerated from there implants they tout the new implants as the new and improved not like the last ones. Everyone seems to forget about teh sealed court documents dow does not want released, it is there internal documents showing how there own data showed the problems from there faulty bags of garbage.
Lets also not forget the Burson Marstellar leaked memo!!
Inamed and Mentor have far from proven these devices from being safe actually what was in there core studies shows exactly the fact there is problems with theres as well, the FDA has no apologies to make other than to the women who are about to be used as guinea pigs again so these corrupt medical device makers and the greedy plastic surgeons can make there millions on a non life threatening medical device.
The FDA did not state they were safe either and when media stated that they need the knuckels beaten.
Science has not proven implants safe never has there has been flawed studies manufacturer paid ones where even those didn't consider them safe.
So until someone does a meaningful study they have not been proven, the manufacturers have had years to do this yet they show up with 3 or 4 year study data the reason that is, is because they don't like the results when it becomes 7 years plus it doesn't favor them so just like Dow, Mentor hired Burson Marstellar to push there product.
Sandra Laliberte
Unlike what is suggested Sandra Laliberte in her comment, there is a great deal science on this as has been discussed her on Platic Surgery 101. FYI, Ms. Laliberte is a Canadian citizen active in the silicone implant debate who has been making the claim for years of a link between her implants and the development of multiple sclerosis (MS). While it's impossible to prove a negative, we know from studies of tens of thousands of patients that there is no increase in the rates of MS or other diseases compared to their peers without implants.
There is no smoking gun. There is no conspriacy of silence by the Medical-Industrial complex. All the allegations of corporate misconduct have been considered any number of times by reviewers and they have now 100% of the time found this to be lacking upon summary judgement.
This is for Dr. Rob Oliver. Concerning your remarks about me and my trying to prove a link I know there is a link.
There is the bought and paid for studies that show no link I don't consider those to be credible though. I will tell you what, how about the plastic surgeons in Canada and the united states get ahold of the claims centre for the dow corning settlement and ask them to release the amount of women in each categorie and since we are on the subject of MS how about you ask about that categorie first. I have said for years that the data sitting at the claims centre is probably the biggest study ever on implanted women. I know for a fact there is alot of women with MS that have a claim filed and one thing with this claims centre is you need medical proof from tests, specialists, etc so it is not an easy claim to get approved. None of them are easy actually you almost have to be a Level 4 nursing home invalid to get approved for the A payment which is a pitiful amount but then again this is not about the money, money will never bring my health back to where it was, but it was all about the money when the MS categorie was negotiated so low and I will tell you why, it was because of the huge amount of women who have MS Dow knew it and knew it from there own studies, and you know the documents they had the courts seal.
I expect your kind of response because this is a great thing for plastic surgeons.
I have nothing against plastic surgeons I just lost respect for many in the profession who decided to take this specialty and make it all about breasts and making women feel like they aren't women without plastic surgery.
I do wonder though why so many of you Doctors hang on the tainted studies by the mayo, harvard, and other studies that have been proven without any doubt to of been flawed. I would think as a medical person you would be more interested in the health and well being of your patients and would want to know the truth.
There is by the way a smoking gun and many of us has read the documents dow tried to hide as did surgiteck at least the ones that weren't sealed and if you would like copies of them I would be happy to forward them to you.
Oh there was a conpiracy and that is why Dow is now paying.
I would of preferred criminal charges though.
I will only believe the new ones are safe when plastic surgeons in writing to all there patients will agree they are safe, but whats the chances of that happening!!!
What do you think the chances are of Inamed or Mentor doing the same? NONE!!!
You must of looked me up to see who I was I see you needed to explain who I was so you labelled me as an activist as if it is a bad thing. I am a woman who has been severely harmed by these medical devices and had 19 operations and still very deformed and mutialted looking so if that classes me as an activist great.
Sandra Laliberte
Ms. Lalliberte,
We'll have to agree to disagree.
There is broad international consensus among doctors, reserchers, and governments that well over a dozen large and high quality studies have repeatedly failed to demonstrate the cause and effect relationship that you support.
While it's impossible to ever exlude something like this with 100% certainty, the data continues to be reassuring and has only been reinforced within the last year from long term follow ups on several of the earlier study groups.
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