Were Saline Implants FDA approved in 1999? Can we litigate?

November 22, 2003

Hi Ladies, I got my implants in August of 1999. Does anyone know if

they were FDA approved then? They were smooth saline made by

Mentor.

Do we have any legal recourse? I'm sure I signed some sort of

release, but I don't think they told me anything about all the auto-

immune illnesses. I thought it was just about having to have more

surgery for capsular contracture and stuff like that.

Anybody know?

Pam...counting down to explant!!!

November 22, 2003

Pam,

Saline implants didn't receive formal approval by the FDA until May of 2000. I was one who testified against the use of saline implants in March 2000 at the FDA Advisory panel, which was a meeting much like the one that was just held in October for approval of silicone gel implants. It was a devastating blow when the FDA went ahead and approved saline implants--the first time in history any breast implant had received the FDA "stamp of approval." I believe it was this landmark approval that gave the manufacturer's the desire to push for approval of silicone gel. Almost everyone agrees that silicone gel implants are much more natural feeling than salines, and I do believe that plastic surgeons are eager to use gels again, even though they've been doing it underhandedly for years, regardless of the ban against them.

Before the FDA approval of salines, implants were "grandfathered" in, meaning that they were already in use before the FDA had the authority to regulate medical devices, so they didn't have to jump through any formal procedure hoops. Then in 1992, the big controversy really hit when the FDA actually banned silicone gel for general cosmetic use when hundreds of thousands of women filed suit against Dow, blaming their silicone gel implants for various autoimmune type illnesses. Since that time, the controversy over the safety of implants has been a raging battle, but mostly behind the scenes, as the media seems to favor just showing the glamour and glitz associated with them, and researchers, mostly funded by Dow and other implant manufacturers, have skewed the studies in their favor to help them win their legal battles. We have Dr. Zuckerman to thank for helping to shed the light on just how these studies have been flawed, and how in fact, more recent unbiased studies have shown increases in certain cancers and fibromyalgia as well as suicide among implant recipients.

Those of us who have been harmed have been trying to let the truth be known, but it has been a hard uphill climb, because of the interests of those with huge financial interests in keeping implants on the market. They want nothing more than for us to go away. They've done a good job of keeping medical professionals from giving our illnesses any credibility, and I am sure there are huge numbers of sick women out there that have no idea it is their implants making their life hell.

As for our legal options, we really don't have any legal recourse at all. (Those implanted before June 1993 may still have some legal options.) Doctors are very careful to have every implanted woman sign her rights away when she gets implants. Basically you state that you understand that implants are experimental in nature and that you will not hold the doctor responsible or the manufacturer responsible for anything......something along those lines....but at any rate, it covers them, and leaves you hanging if you should get sick. Not only that, lawyers now know that the manufacturers have found out how to win in court (with all the studies supposedly clearing implants of any implication in disease), and are unwilling to take on any cases. Just finding a lawyer is hard enough. Bottom line is that the manufacturers and doctors win, and we lose all the way around. It's a gross injustice, incredible in this day of lawsuits and medical malpractice. Implants are one of the biggest crap products of the century, and yet common sense has flown out the window with them. (It's because it's boobs we're dealing with, and men making the decisions....!)

Let us know when you are set for your surgery!