Fwd: 12-582 nml FW: Check out Study of Re-operations and Self-Reported Silico...

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This is in response to your email to the Food and Drug Administration (FDA), regarding the approval of silicone gel breast implants. Silicone gel breast implants are not approved. They are still under review.

FDA appreciates your interest regarding our review of premarket approval (PMA) applications for silicone gel-filled breast implants. We would like to assure you that we intend to perform a thorough review of all the data in the PMA applications in determining whether they demonstrate a reasonable assurance of the safety and effectiveness of these devices. FDA has received one PMA application from a manufacturer, Inamed, that is currently under review. This was the first PMA submitted since silicone gel breast implants were taken off the market in 1992. In our review of this and any other PMA for silicone gel-filled breast implants, we will consider data collected in the core clinical study (the primary study from the investigational device exemption (IDE) application), as well as information from the larger adjunct study (the public health need study for reconstruction and revision patients), medical device reports from a variety of databases, and published scientific literature.

Regarding the PMA application currently under review, on October 14-15th, we sought input from an Advisory Panel of outside experts on the data contained in the Inamed PMA during an open public meeting. In a 9 to 6 vote, the Panel recommended approval of the Inamed PMA with conditions. It is important to note that the Panel makes a recommendation to FDA. FDA ultimately makes the final decision. FDA's review of the Inamed PMA continues, including discussion of the Panel's recommendation and conditions of approval.

The Panel agenda, package, roster, FDA slides, and Panel brief summary are available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=388.

The Panel transcript is available

* For free on FDA's website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=388.

* For purchase from the FDA, Freedom of Information Staff (FOI), 5600 Fishers Lane, HFI-35, Rockville, MD 20852, 301-827-6500 (voice) or 301-443-1726 (FAX).

* For purchase from Reporting, 735 Eighth Street, SE, Washington, DC 20003-2802, phone: 202-546-6666; FAX: 202-546-1502.

FDA assures you that your concerns and interest about the safety and effectiveness of breast implants and the need to provide adequate information to women regarding the risks of breast implants are important to us.

Resources

Breast Implant Website - The breast implant website is a valuable source of information on implant procedures, special surgical concerns, post-operative care, and topics to discuss with your surgeon that can help you make your decision. The breast implant website also includes the breast implant consumer handbook and patient labeling for the approved Mentor and Inamed saline-filled breast implant products. The breast implant website is at http://www.FDA.gov/CDRH/breastimplants/.

MedWatch - MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions and problems with medical products, such as drugs and medical devices. The MedWatch website is at http://www.fda.gov/medwatch/how.htm.

BI ListServe - You can subscribe or unsubscribe to the BREASTIMPLANTS list by going to http://list.nih.gov/cgi-bin/wa?SUBED1=breast-implants & A=1.

I hope the information I've provided is helpful.

M. Leonard Public Health Advisor Consumer Staff, HFZ-210 Division of Small Manufacturers, International, and Consumer Staff Office of Health and Industry Programs Center for Devices and Radiological Health Phone: 1-800-638-2041 extension 141 Fax: 1-301-443-9535

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

-----Original Message-----From: RSLB49@... [mailto:RSLB49@...] Sent: Tuesday, December 30, 2003 2:51 AMdz@...; ParfumGigi@...; Gimfl@...; chathcock@...; Kathynye@...; Lany25@...; SBIPrayerForum ; tcc21922@...Cc: breastimplantnews@...; cass.ballenger@...; david.price@...; tortcom@...; bparnell@...; ilena2000@...; implants@...; REUSE@...; dsmica@...Subject: Check out Study of Re-operations and Self-Reported Silicone-Gel Breast Implan

Click the link that's below this message:

What? The FDA going to approve something that they did THIS STUDY on???? What's wrong with this picture? PR? Money? Big Companies? More money than we sick ladies can offer? LISTEN UP~~~ FDA~~~There's going to be many more sick women than now. Listen to the voice of reason and experience. All of the women harmed already and your own reports. What else is needed? More sick and dying women? What will it take? It's to late for us but, not for the one's you can prevent from harm. I'll be saying (If I live long enough) "I told you so." If not me, my children and grandchildren will let you know. For sure; all the women you will allow to be harmed all over again. This piece of History Will Repeat Its Self As soon as you approve the Implants for all the Manufacturing Companies and Plastic Surgeons to abuse women again with. We aren't pig's and rat's. We are human's. Gods people. It was tried on us, before trying it on animals. I can't say animals deserved it either!

I remain: Silicone Implants of eleven years. Removed, with Silicone that was once there, inside my chest cavity except, upon time of removal, gone. The outer Shells, gone. Health, gone. Job of nineteen years with IBM, gone. The fun of outings with my family and kids, gone. The joy of marriage (still together), gone. Money saved for retirement, (spent on Doctor's and Medicine's) gone. At least my Husband, Doctor's, (Medical and Rhuematologist) and Children 'believe' and are Not Gone. The proof is in the x-rays, blood work and operations I've had. I pity the women begging for help with Doctor's and so many others (example: the FDA) not helping or believing them. Do you know how many Doctors and Husbands turned their backs on them? No wonder so many kill themselves. Put yourselves in Their Shoes. The only way for you to do that is; Get IMPLANTS for A Few Years. Let them poison your system.

At least our President stepped up and took a shot, (Anthrax) along with our Military and other Americans. How about Silicone for you, before you pass anymore around. If it was good enough for us, it should be good enough for you. If you know enough to approve it, be brave enough to try it. I'm not asking you to get a great big breast implant or two. Just let them inject a little underneath you skin for a while. You'll get it out when it starts burning, hurting, or turning into rot.

Oh~~~ Did I say I'm begging you to 'not approve' Silicone Implants no matter what lies you are told? If not; I'm BEGGING YOU NOW! I can't believe I'm even doing that. My Mother taught me to never beg for anything but, I HAVE TO go against the grain, this one time. I'm Sorry sweet Mother Above: If it means telling the truth and standing up to save lives, you'd also tell me, to do what is right. Since Mother has left us, a few months ago, I'm sure she's met the much to young Mothers, Daughters and Sisters, that went on before her, that didn't make it to her ripe age of 86 years, due to Poison Silicone. Knowing her like I do; after seeing how Young some of the Angels are there, still needed here, by her families, i.e., husbands, and little babies, killed by poison, that could have been prevented. She's up there NOW Begging and I'm still down Here Begging. By now, she knows if no one here cares enough to stop it ~~~~ God and Her will find a way! Doesn't it bother you what you are allowing to happen, to God's and Our world and his people? Or, am I supposed to leave God out of this also and let the Poison Silicone stay? Yes, money talks but God and Mother will talk the loudest.

Click here: Study of Re-operations and Self-Reported Silicone-Gel Breast Implant Rupture (Interview Component)

Silicone Suckered (Suckered into how safe they were)

(We are Your Proof)

God Bless America, May he Destroy Silicone, deal with the Money Hogs and heal the Suffering and Dying, Due to Silicone!