The FDA Asked Us to Tell You…
So here we are before our FDA meeting. It’s always a little intimidating to go see your government officials, but we have learned over the years that as consumers it is important to speak out and let the FDA know what’s going on with women. When you focus on the fact that the visit could actually benefit all of us, then it’s not as scary. The FDA needs us, too, you know.
Our meeting at the FDA was interesting and informative. Here we are with Dr. Uhl, assistant commissioner for women’s health at the US Food and Drug Administration. She was happy to know of our work with the different support groups. She supported all of us working together to help educate women and keep communication flowing.
Sybil and I brought to the FDA your information about what’s going on with implants. They wanted us to tell you all that they have been working hard to regroup and get the post-approval efforts aligned on this product. They have a plan and encourage us all to go to their website and read it as well as the official approval recommendations. They have a detailed list of what they are following up on with the manufacturers. They wanted you all to know all this is available.
We complained about the call-in number for reporting problems but found out that the best way to get these issues reported is to go online and fill out the downloaded forms and officially submit them to the FDA. They said they can’t help if we don’t report properly. Hey, it’s the government. Did you think there wasn’t a protocol and there wouldn’t be paperwork??? 
If you do call, the person who answers the phone will direct you to the online reporting forms. When we said we thought an actual person should be available to help, they explained that sometimes the questions are complex and the person answering the phone is not usually an expert. The way to get the attention of the right people is to follow the procedure that leads directly to them.
So that’s the FDA update. Keep letting us know what the issues are and we’ll keep working to get them heard!
On that note, I would like to thank all of the men and women who write and comment on this blog and contact our websites, breastintentions.org, commandtrust.org and intheknow.org. You have a voice and you let us know what’s REALLY going on with this implant issue as well as with women’s health.
It’s so important to get the information out there. Whenever Sybil and I get overwhelmed by the scope of it all and feel it’s an uphill battle, we remember all of you and all we have gone through and we KNOW this is a worthy fight. Especially for the new women having complications with their implants and getting really sick. We really want to hear from women who are currently having problems so we can help them get the information they need.
Again, thanks, all of you, for being a part of this blog community and helping us work on behalf of women’s health!
Go Sybil and Mary!!!! You two rock!!!
Comment by suzannabanana23 — January 15, 2008 @ 3:57 pm
When I was early on in my sickness I called the FDA Numerous of times, asking them over and over is there any way this sickness can be from my saline implants? No they were clueless? I do have these conversations tape recorded as well as tape recorded conversations with the manufacturer. They both were clueless and no help what so ever to me. I went on sick for over a year later, until bed ridden and wanting to commit suiside. God sent me to wonderful ladies who shared every symptom I had from there “safe” implants. I then called the Manufacturer and the FDA back, once again tape recorded the conversation. The FDA was no help to me, when I ask them about the 90 page booklet, I did not recieve, they said, it was not mandatory for the PS to give this to me. Then I called back and another lady said it was… They denied MOLD in Saline.. The manufactuer however admitted to Mold in the Saline, however they were clear to say it is from the saltwater contaminated upon the PS putting it into the implant. I want to know why the FDA can’t get there story straight. When I did my Med watch report it was lame and a few sentences, looked as though they were covering up for the manufacturer. They have heard of these problems by Med Watch reports, yet failed to tell me any of them. The manufacturer failed to tell me a year earlier, it was only when I said can MOLD grow inside of implants, they said anything is possible. They are not giving informed consents, which should include two main issues that are overlooked in our informed consents. Number one is the RISK of a defective product or faulty valve. The Second One is the fact of Mold being able to grow within a implant, whether from the PS or a defective Valve, we have the right to know this valuable information. If I would have read those two sentences upon searching for why I was sick after getting my implants, then I would have figured it out alot sooner, which I totally believe I would not have gotten as sick as I am today…FDA needs to do there job…
Comment by toxicsalines — January 21, 2008 @ 9:12 pm
Mary & Sybil, I’m glad I had the opportunity to protest outside the FDA building with you both a couple of years ago, so glad to see you on the inside of the building now! Thank you for your tireless effort to fight for us and for the many women who may decide NOT to get implants in the future once the FDA decides to make the public aware of the real dangers. My hats off to you both!
Tammy from Seattle
Comment by Tammy Gabriel — January 24, 2008 @ 11:53 pm
Dear Mary and Sybil,
God bless you for what you are doing!
It takes people like you to educate society about these “toxic balloons” and the damage they cause to women physically and mentally.
But what’s even worse is the long-term effects it will have on the entire family.
Comment by Tammy Spagnuolo — January 25, 2008 @ 9:05 am
WOW! I want to thank you all for your lovely comments and suppport. I loved picketing outside the FDA adn I know that it is part of HOW we got INSIDE. Thanks to all the women who have rallied with us over the years.
To our 2 Tammys…you rick. Many thanks. Your comments keep us going when it seems this si SO unpopular and no one cares anymore.
Toxicsaline, you are so great to post your experience. Incredible. We will send this to the FDA and hope thay see your response. We can’t TELL them if you don’t TELL us Thanks for the heads up.AND for posting.
Mary
Comment by Mary — January 31, 2008 @ 12:05 pm