Will the Next Wave Be Déjà Vu All Over Again?
The other evening I was lamenting with another woman the fate of the second generation of women who will become ill from silicone implants. It wasn’t a question of “if” – it was a question of “when.” Definitely, we agreed, it’s going to be déjà vu all over again.
Since the FDA allowed silicone breast implants to return to the marketplace last November after a 13-year moratorium, the clock has begun ticking for the arrival of a second wave – women who will begin to report illness and ill effects from the new generation of marketed implants.
In past years, the first wave women organized and became the catalyst for action, educating the public, important panels, government and the media, about the perils of this product. As these earlier victims of silicone implants begin to age, become ill, and voices become silent in that process, who will the new faces be? Who will take up the gauntlet to educate the public about the dangers of silicone?
The FDA hasn’t demonstrated the will to protect the public from many products from the implant industry. At one notable FDA hearing leading up to the re-approval of silicone implants, panel member Dr. Barbara Manno said, “I think we have got enough to approve this and that the recipients of the device will have a choice. And it isn’t to have a choice, they can make a choice and it’s tough luck if it doesn’t work.”
We have watched with dread as implant manufacturers pushed hard to limit product liability and ratchet down liability levels in order to discourage claimant attorneys from pursuing litigation for harmed women. We have watched with dread as manufacturers built in defensive protection by having women entering their plastic surgeons’ offices immediately sign away their disclosure rights prior to implant procedures.
Clearly, this new wave of women implant recipients isn’t protected.
The first wave of silicone victims had many claimant attorneys working in their environment, because there were many settlement dollars on the table. Although the settlement dollars didn’t ultimately trickle down equitably to the women, they did act as a very effective motivation for the victims to stay in communication with one another, and much education to the public and the media came through the process. Furthermore, some assistance was available through the support system to help women deal with various aspects of their predicaments. But with limited liability for the manufacturers and the women without even the right to disclose their stories, these resources and mechanisms are not so available today.
What concerns me about this second wave of implanted women is: Who will be there to assist them? Who will take them by the hand and help them find good doctors to treat them, and to find quality care? This second wave of harmed women will likely have more to overcome than we had, and it’s likely that it won’t be too long before we begin to see them arrive.
None of us has a crystal ball. It will be interesting to look back 10 years from now to see how the second wave coped and managed.
I wish them luck.
Sadly enough, I’ve already met some of these women. Several have already had to have them removed because of health problems. One in particular had very severe problems. She only had them for three weeks!
I’ve heard the words ‘new and improved’ to describe these implants but in my opinion they are just the same as the old silicone gel implants - filled with chemicals that can wreak havoc on the body. Nothing new about that.
Comment by bethtaylor — November 1, 2007 @ 6:53 pm
On one of the newsgroups, a poster came on to say, the First Wave experienced NO proven illnesses.
For those that wish to believe that - they only need to look to the 440,000 women who signed up with the MDL Global Settlement. The courts waited and prolonged the deadline for signing up for that Class Action, until they could lasso and corral every possible breast implant victim they could, for the manufacturers benefit.
Once the MDL signup deadline passed, they began what they termed as
“random samplings” of the medical records of the women, to determine
how many qualified for the disease catagories. Once the “random samplings” were complete, Dow Corning filed for bankruptcy. Those “random samplings” were loaded with so many disease ridden women from their implants, that it literally forced the company into bankruptcy, rather than comply with paying out the amounts promised on the grid.
It collapsed the Global settlement.
What was in those random samplings, pparently was so damaging to anufacturers, that an EXCLUSION to te Freedom of Information Act was imposed. Those records, and the damage contained within them, are
forever sealed, and will never see the light of day.
Since the 1960s, breast implants have been part of one kind of study
or another. The source for funding of those studies, has usually come
from the manufacturers themselves, with an agenda in place to market
the product.
Most women who were implanted had no idea that breast implants had
never been approved by the FDA. So here we are more than 40 years
later, still studying breast implants, and using women as the guinea
pigs. A few rounds of guinea pigs “might” be thought as acceptible.
But alas, industry seems woe to keep track of their guinea pigs. In
my 12 years of involvement in this issue, I have yet to talk with a
single woman, who was part of a study, that came to any fruition.
Recently, we saw evidence, that the manufacturers are simply
regurgitating old studies, and making them look new again. . .They
prove nothing! The manufacturers stance seems to be to pour money
into lobbying efforts to have malpractice limits significantly
reduced, and to create disclosures absolving themselves from
responsibility, in addition to stacking the FDA panels with
pharmaseudical and device industry people.
This second wave of victims, is going to be behind a rock and a hard
place, with little or NO avenue for recourse.
Myrl
http://www.webstarmagic.com/wisletter.htm
Comment by Myrl — November 1, 2007 @ 8:15 pm
Thanks for this informative piece, Myrl. I too believe that this will happen ALL OVER AGAIN! It already is. Women are already getting sick and writing us wondering where all the infomation is. Where were all the warnings. I am always shocked that in the 12 years I have been doing this outreach, no one had heard me!
It is so sad that the FDA adopted the Touch Luck standard of excellence
Comment by Mary — November 2, 2007 @ 5:25 pm
Yes, it is really upsetting that the FDA seems to be locked in it’s “Tough Luck” standard.
I still believe that plastic surgeons are white washing the disclosures they put in front of the women.
Often, I think men and women of today are so busy keeping their noses to the grind stone, they don’t hear all the dangers which we attempt to present.
And, not all women become ill with implants. At least not right away. There are enough “success” stories out there, that women think it’s safe for them to go ahead. That the bad experiences only happened to a few of us.
What they don’t realize - is that it CAN happen to them. And when it does, it’s 100%
Comment by Myrl — November 2, 2007 @ 9:15 pm
Our online community is already hearing a lot from the newer generation of implant victims, too. Not only the new generation silicone implants, but many saline owners are throwing in the towel as well.
The first wave focused on the related illnesses and eventually seemed to disregard the asthetic problems. It is so hypocritical that looks are the catalyst for pushing augmentation, and then looks are totally ignored after implants cause imperfect breasts. Perhaps this next wave will be so appearance motivated they will find a way to address this aspect of things.
Sadly, these issues may have to become worse before they take another serious look at the implant controversy. If they couldn’t see the similarities between silicone injections in the breast and silicone bleeding, I don’t know if they will see it until it happens to them or someone close to them. At least they won’t be accused of having an agenda or to be motivated by money, like we were. They have NO ability to sue, it appears.
Comment by jeena — November 12, 2007 @ 11:38 am