FDA Panel Calls for Silicone Breast Implant Registry

Emily P. Walker
MedPage Today
September 2, 2011

GAITHERSBURG, Md. — A federal advisory panel has recommended the creation of a nationwide database to follow women who have had silicone-gel breast implants for at least a decade after they had the surgery.

The two companies that manufacture silicone implants — Allergan and Mentor — are required to follow women who’ve had their implants for a number of FDA-mandated studies, but enrollment in those follow-up studies has been disappointing, and in some cases the number of women being followed is so small that FDA cannot definitely rule out a connection between implants and a rare disease, such as anaplastic large-cell lymphoma or connective tissue diseases.

The FDA’s General and Plastic Surgery Devices Panel, which wrapped up a two-day meeting Wednesday afternoon, said that current data collection demands are too onerous. Both companies ask women who’ve received their implants to fill out a 25-plus page questionnaire every year following surgery. Not surprisingly, not many women do that.

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12 Responses to “FDA Panel Calls for Silicone Breast Implant Registry”

  1. That is definitely Invasion of Privacy!!

  2. I doubt whether anyone who can keep a household has anything to be ashamed of, physically, but I do prefer naturally petite women.

  3. Translation: We need to find a new excuse to gate rape you at airports.

  4. LEE ENIGMA SAYS :
    WHAT NEXT AMERICA, WITH ALL THIS GOVERNMENT CONTROL ? WHAT WILL WE SEE NEXT CONDOM REGISTEY WHER DOES ALL THIS GOVERNMENT INTERVENTION STOP ?
    SOME THING ARE PERSONAL AND I DON’T THINK A WOMAN WOULD WANT THIS INFORMATION TO BECOME PUBLIC INFORMATION ! HOW ABOUT A CZAR REGISTRY AND WHAT HOW MUCH THEY ARE PAID ? I WONDER IF O-BUMMER HAS A SLEEPING PROBLEM AND THINKS THESE
    CRAZY THING UP AT NIGHT ! I CAN BET THE ARE PLENTY ON DOCTORS WHO DO BREST IMPLANTS FEELING O-BUMMER CUTING INTO THERE PAY CHECK ! HEY MR. O-BUMMER HOW ABOUT STAYING FOCUSED ON NEW JOBS FOR AMERICA AND NOT HAVING CEO SEND AMERICAN JOBS OVER SEAS ! WELL SEE YOU AT ELECTION TIME MR.O-BUMMER !

  5. Does this mean Obama will register……..after all he is the biggest boob of them all !

    • NAZI HUNTER, you get the best comment award, haha.

  6. I had silicone implants and saline over a period of 10 years, I had a slew of unexplainable health issues, I had to have glasses due to strange vision problems and even the glasses didnt help much, I had silicone in my lymph nodes with UNruptured implants…I had hairloss, vertigo, breathing issues, my skin would react to ANYTHING that touched it, my breasts were numb, cold and I lost a lot of my natural tissue due to mulitple surgeries due to plastic surgeons mistakes and other complications. The list goes on and on. When I had my implants removed…most of these health issues went away over a 5 year period …I dont need glasses anymore. They do still find nodes of silicone inmy body from time to time and I tested high for titanium and arsenic and mercury…I dont have mercury fillings either….I’m 38, healthy but flat chested with a 32A/AA breasts….I started as a natural B cup and the surgeons never toldme I would lose my natural breasts with the implants….the reason women get them is because they know MEN like big boobs….trust me, no matter what they say it all boils down to some male making fun of them or calling them flat chested and it blows their fragile self esteem into the dirt and they run to the nearest plastic surgeon to “fix” the problem….sad really, I fell into the trap, but now that I am older, I really don’t care what anyone thinks….call me flat titted, I dont care. I am alive, I am super petite and if that’s not your thing don’t waste my time calling me names or pointingout my breast size….unless you’d like me to point out your I.Q. and penis size. Implants are deadly, they kill women

    • No one should never get a boobjob cause of what men think. its bs . all ur going to be attracting is dogs neways if boobs make the difference. im sick of women being taught they’re natrually not good enough thats bs. Obviously it’s bad for your health as well.

      • on top of it the governments gonna hunt u down. crazy

    • Glad to hear you feel better now. Men, aside from the common inbred misogynist, like women. Simple. No matter what they look like, size, age, race, hair/eye color….doesn’t matter. Don’t buy the hype about prototypes. Sexiness is an attitude and starts in the brain. Therefore alot of men have been convinced in their brain that they prefer the bigger this part or that part, when it’s been societal conditioning. Our minds are terribly influential, just look at who is in the White House!
      LVX
      Amy

      • I worked in a hospital on a floor that was all women except for me . They were discussing breast implants and cosmetic surgery . When I said I was totally against it they were surprised. For one , in my opinion , very few cosmetic surgeries actually make a person look better . They usually look fake or lose the character that made them unique . Of course , there are deformities and people who have suffered trauma and that is completely different .

        Having worked with mostly women for 15 years , I have to call you on one thing . Blaming only men for pressures to have cosmetic surgery and all of the money you spend on appearance is dishonest . Competition to be included and one up each other is much more a factor than what any man says . Truth is women want to be accepted by other women far more than their husbands or boyfriends . If you want your husband or boyfriend to really treat you well , be happy with what you have ( settling is not appreciation ) , don’t compare him to other men , dress for him , not the girls at work , don’t introduce him as ” this is my husband / boyfriend he is or does …. we are not a plow horse you bought at the auction , and if he has a hobby or interest , don’t pretend you are allowing him time to do it ( he is not on your clock ) . See , there is much more to a man than how big your boobs are . In reality some women get big boobs so they don’t feel like they have to actually take a real interest in the husband/ boyfriend .

    • I love small breasts. I’ll take small over big any day!

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