Silicone implants: Safe, need monitoring
June 22nd, 2011
06:11 PM ET

Silicone implants: Safe, need monitoring

Silicone gel breast implants are safe according to the ongoing monitoring by the FDA.  However, women must understand that silicone breast implants are not lifetime devices and the longer they have them in, the higher the likelihood of developing complications, according to Dr. Jeffrey Shuren, director of the FDA Center for Devices, .

“One in 5 women who received implants for breast augmentation implants will need to have those implants removed within 10 years,” said Shuren.

Complications from implants include the formation of scar tissue around the implant, an implant rupture and the need for more surgery or removal of the insert. Women also experience breast pain, wrinkling and asymmetry. Manufacturers and physicians must continue to provide up-to-date information to patients who are considering breast implants, according to the FDA.

In January, the FDA reported a link to silicone gel implants and a rare cancer that affects the lymph nodes.  Wednesday Shuren said there is no evidence so far that links the implants to breast cancer among other illnesses.   “To date, preliminary data does not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or are connected to tissue disease such as rheumatoid arthritis or lupus,”  he said.  He did go on to say, however, that in order to rule out these possibilities entirely, studies must be conducted for a longer period of time.

A statement from Dr. Sidney Wolfe, director of the Public Citizen’s Health Research Group, said the FDA’s assurance of safety is, “unquestionably shortsighted as well as contradictory.” He added, “The FDA’s acknowledged inadequacy of implant company safety studies makes their continued use resemble an experiment on women, rather than a product with a reasonable assurance of safety.”

Dr. Phil Haeck, president of American society for plastic surgeons, says
80% of women still have their implants up to 10 years and they are satisfied.

Last year,  296,000 women received breast augmentations and 90,000 received reconstructive breast surgery according to the American Society of Plastic Surgeons. The announcement by FDA Wednesday is part of the overall monitoring of silicone gel breast implants that will continue at least through 2016.

Twelve years after silicone gel breast implants were introduced in the U.S., they were updated to the highest risk category, Class III in 1988. The back and forth over safety continued through the 90’s. In 2006, the FDA approved two different silicone breast implants only after requiring each manufacturer to conduct studies on safety. Wednesday's announcement by the FDA was part of monitoring of those studies by the manufacturers.

soundoff (39 Responses)
  1. Natural34DandPROUDOFIT!

    Again I do not understand the appeal of breast implants.... they often do not look natural and it's something foreign to your body being lodged under your skin!! Yuck.... Natural boobs whether they be small or big are always better.

    June 23, 2011 at 09:32 | Report abuse | Reply
    • Kristen

      Breast implants have come a long way. The boob jobs that look "fake" are often cheap and not done very well. I went from an A to a C when I was 30. People who didn't see the before, think they are completely natural. It all depends what you get. natural breasts also sag, which isn't attractive.

      June 23, 2011 at 11:34 | Report abuse |
    • Valerie

      BS Kristin- I'm a NATURAL C and I do not sag at all...I keep in shape....fake looks and feels fake....say anything you want, NOTHING beats natural. You sound jealous.

      June 23, 2011 at 12:40 | Report abuse |
    • FamilyBreastCancer

      When you lose one to breast cancer, see if you are so proud of the one on one off headlights. Also know a few 'natural' 38A's who wouldn't mind a little boost.

      June 23, 2011 at 13:39 | Report abuse |
    • Carl

      Lawyer who wants to help women who are in pain from implants who have the gel silicone implants.
      Carolyn salzmann407.423.4560....please call she is very nice and is in the beginning stages of helping women. She is helping my wife right now

      November 5, 2013 at 22:45 | Report abuse |
  2. Pat Savu

    The only reason to have a breast implant is if you had a mastectomy. yet something lik 90% of all implants are for cosmetic reasons. I had saline implants for 18 years before one deflated and I had to have a repair. Now I have those gummy bear silicone implants. They are a lot more natural than the saline ones. Those new gummy bear silicone implants are more cross-linked than the old liquiid silcone ones and have a lot lower chance of leaking into your body even if the capsule of thwe implant breaks.

    June 23, 2011 at 10:14 | Report abuse | Reply
    • Kristen

      Mastectomy is only one reason to have breast implants. There many genetic disorders which cause chest wall deformities and other things that make someone look disfigured. If breast implants cover it up, there is nothing wrong with doing it!

      June 23, 2011 at 11:37 | Report abuse |
  3. Michelle

    I feel bad for the women who have been convinced by society that they need grotesquely unnaturally huge breasts in order to be attractive. Here's a newsflash, ladies: men prefer them natural, first and foremost, and most of them don't want anything bigger than a D. Most of them prefer B/C cups. I just asked a bunch of my buddies hanging around the office... and when I mentioned women with breast implants, two of the guys looked grossed out, one of them laughed, and the other shook his head and said he couldn't understand why women would take their naturally beautiful bodies and mutilate them. They all said they'd rather have a girlfriend or wife with a natural A-cup than any size of fake breast.

    Think about that before you mutilate yourselves, ladies.

    June 23, 2011 at 10:16 | Report abuse | Reply
    • Kristen

      You are assuming that all women who get them could give two craps about what men think. If you get them to impress men, that's stupid. How about if you get them because people can be incredibly cruel and constantly tell you, you look like a boy. Be tortured...or fix it? Fix it. Hands down.

      June 23, 2011 at 11:39 | Report abuse |
    • Pat Savu

      People can be incredibly cruel to anyone who is different. It can be becasue they have bad acne, are fat, too short, wear glasses, or even because they are black. It doesn't mean that you have to let this stuff get to you and feel like less of a person.

      June 23, 2011 at 11:47 | Report abuse |
  4. Mike Distance

    A woman has a right to mutilate her body as she pleases. No man, woman or child has any right to tell her otherwise. There is nothing more important than a womans outward appearance even if it proves to be false. If she appears to look good with makeup, hair extensions, enhanced breasts, spray on tan, heightening shoes, slimming belt and butt lumps in her pants then we should applaud her ingenuity. Let us all praise the FDA for allowing women the right to choose.

    June 23, 2011 at 10:16 | Report abuse | Reply
  5. Kristy

    I was an A cup until I was 24, and got implants. I never had a problem with the guys because I was flat, but my chest always bothered me. I did it for myself, and nine years later still couldn't be happier with the results. I went for a reasonable size, and they look great.

    June 23, 2011 at 11:13 | Report abuse | Reply
  6. Burbank

    I was in our local neighborhood pub on a Friday night a few years ago. There was this beautiful young woman about 28 years old telling the bartender that she was going to get implants. She was slender with about a 34 B breast size, she had a very pretty figure. The bartender and I were horrified and said don't you dare! I then told her I would conduct a survey to prove something to her.

    One by one, I presented to every man in the bar a hypothetical situation (this is a neighborhood place where everyone knows each other): You have an imaginary girlfriend. Her breasts cannot be average, they are either too big or too small, which would you choose? I asked 50 men and kept track of the answers, the results were an even 25 too small, 25 too big.

    I went back to the pretty girl who was still talking to the bartender with the survey results 30 mintues later: Out of 50 men, exactly 1/2 would prefer a woman that is smaller than average, 1/2 would prefer larger. What this proves is that men don't really care at all, as long as you have them! – She ended up not getting an operation.

    June 23, 2011 at 13:00 | Report abuse | Reply
  7. Vera

    Are you interested in preventing millions of women from getting breast cancer in the future? Then take a look at these two youtube videos about a potential breast cancer vaccine that may prevent breast cancer altogether! And please pass this information on to your friends and family!



    June 23, 2011 at 16:00 | Report abuse | Reply
  8. Peter

    I saw this segment the other day and was shocked that Dr. Gupta when referring to the potential health risks such as Lupus stated "these have since been shown not to be the case". It's nice that the actual article references other doctors who argue that the FDA's study is far to small to reach any conclusion. However, Dr. Gupta's television appearance I'm sure reached a much broader audience. The actress Mary McCormick recently wrote a book largely dealing with her implant/Lupus experiences and how the medical community and special interests conspire to silence the truth of the matter to protect the business. Dr. Gupta, are you on the Dow Chemical payroll as well? When you consider the influence of your position, please be mindful of the responsibilities that go with it!

    June 24, 2011 at 02:32 | Report abuse | Reply
  9. Patsy

    This segment really scares me a lot. I had a mastectomy in 1990, and had the trans flap (stomach fat) reconstructive surgery. The doctor put a small silicicone implant in my healthy breast because it was smaller than the one they built from the stomach. I've had lots of pain in that breast and have tried countless times to have the implant removed, can't find a doctor that will do it unless its clear that it ruptured, if it isn't insurance won't pay for the surgery. Now I'm unemployed and on medicare and can't even find a doc to discuss it with. Also now am having lots of other health problems that could be related to the implant and can't afford to do anything about it. One doc told me to go to the doc that did the original surgery (he happens to be dead) I would never recommend these things to people or the kind of reconstructive surgery I had to re build the breast that was removed because of the cancer

    June 25, 2011 at 17:34 | Report abuse | Reply
  10. julia

    I have double silicone implants due to cancer. Am grateful to be reconstructed. However implants are uncomfortable and I can't sleep on my stomach. I can't imagine any women doing this for cosmetic/augmentation reasons. It's painful and the surgery is no fun. Imagine having heavy water balloons behind your pectoral muscles!

    June 26, 2011 at 22:05 | Report abuse | Reply
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  12. Dr Vitenas

    This article provides an interesting history of popular opinion on the safety of silicone breast augmentations. Having performed thousands of silicone breast augmentation procedures over the course of my career, I can tell you that the advances that have been made in implant technology have been staggering. The most notable of these came with the reintroduction of silicone breast implants within the last decade. Where the plastic implant shells used to be filled with liquid silicone, they are now filled with silicone that is in the form of cohesive gel. Because breast implants do not last forever, they generally need to be redone every ten years, the cohesive gel is not capable of leaking and makes for a much easier operation when it comes time to do an implant exchange. Feel free to take a look at my recent blog post about breast revision surgery http://www.drvitenas.com/blog/03-15-12/breast-revision-correcting-unexpected.html

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