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The Truth About the Safety of Silicone Implants?

Hello! Why don't doctors & manufacturers want to show records of patients who have had the FDA approved silicone implants for a period over 5 years? Doctors quickly disregard the horror sites of women who felt strange symptoms but why does the National Research Center for Women & Families also mention these symptoms & question the actual safety of implants. Thank you!

Doctor Answers (3)

The Truth About Silicone Implants

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The literature is full of scientific studies with long term follow up and results reported looking at 5 and ten year data and even longer follow-ups. This data is available by searching the FDA site simply on the internet (see my below link).

Despite three decades of safety testing and monitoring of silicone breast implants, there is still a public perception that silicone breast implants are more toxic or dangerous than saline implants. The truth is that there has no known toxicity from silicone gel breast implants. In fact, silicone is one of the most common materials used in medical devices and implants. There is no known toxicity from silicone gel breast implants. It has been studied by the FDA for more than three decades to establish its safety. Silicone is the most common material used in medical devices/implants. Examples include shunts that go from the brain to the abdomen (for hydrocephalus) which are left in for a lifetime, artificial finger joints, syringes, IVs, catheters (including ones that go next to the heart), surrounding pacemakers, and even oral anti-gas tablets.
The one possible exception may by the PIP implant made in France (generally not available in the USA). Most of the concerns about the PIP implant were about the use of non-medical silicone and manufacturing problems, and do not relate to implants used in the United States by board-certified plastic surgeons. This is not to say that breast implants, like any implant, can have problems; they may have to be removed and are not meant to last a life time. Common reasons for replacement include: capsular contracture, rupture, infection, change in breast size, and pain—but not for toxicity.
To answer the perceived toxicity of Silicone by the general public—this is quite a different matter.
Breast implants have been around since the 1960s. About 15 years ago Connie Chung ran an exposé, Face to Face with Connie Chung, claiming silicone implants were responsible for different health problems. This led to lawsuits, a huge windfall for lawyers, and the subsequent ban on silicone implants for first-time breast augmentation patients went into effect. They were always available for breast reconstruction (e.g. after mastectomy) and replacement of existing silicone breasts. Also, please note that saline implants are still covered by a silicone envelope.
Soon after, a ban on silicone implant use became worldwide. This lasted for years until more than 100 clinical studies showed that breast implants aren’t related to cancer, lupus, scleroderma, other connective tissue diseases, or the host of other problems they were accused of causing.
June 1999, The Institute of Medicine released a 400-page report prepared by an independent committee of 13 scientists. They concluded that although silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants do not cause any major diseases such as depression, chronic fatigue syndrome, lupus or rheumatoid arthritis, etc.
The Institute of Medicine is part of the National Academy of Sciences, the nation’s most prestigious scientific organization.
Eventually, a federal judge dismissed/rejected the lawsuits, declaring them junk science and ended for the most part the barrage of lawsuits. This led to the present reintroduction of silicone implants years ago and their approval by the FDA. Interestingly enough, most of the rest of the world reintroduced them many years prior to the United States.


Orange County Plastic Surgeon
5.0 out of 5 stars 43 reviews

Silicone (and saline-filled silicone shell) implants ARE safe!

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First, read Dr. Gutowski's excellent answer. Click on the links. Read to your heart's content. No one wants to "hide" information or "fool" the public. It sounds as if you (or someone close to you) has had problems or issues. I am truly sorry, but that does not deserve excoriation and condemnation of "Doctors" as if we all are part of some massive conspiracy to hide the truth from the public or you. (And I liked the X-files!)

Lots of groups (some with very serious-sounding names) are simply mouthpieces for one or more individuals with an axe to grind against doctors or implants, when what happened to them were bad outcomes, poorly-performed surgery, or just plain bad medical luck. This is unfortunate, but should not detract from the science, OR the truth!

Breast implants have been the most exhaustively studied and tested products in the medical marketplace, and not just by implant companies. Dozens of studies by credible scientific entities (Harvard, Mayo Clinic, Canadian, European, and American university researchers) have found NO cause-and-effect between silicone gel (or silicone shell, saline-filled) implants and ANY autoimmune illness. And trust me, they've looked. Hard. Anyone who publishes a peer-reviewed, reproducible study that identifies a "real" problem with implants will immediately become famous, and not for just 15 minutes. So lots of "not-vested-interest" researchers who would benefit from "breaking" this news have tried and failed to make precisely the point you are concerned about.

I'm certainly not disputing the validity of any individual patient's own personal experience. It's just that if you take 10 million women with implants and 10 million without, you can find examples of whatever you are trying to "prove." Put a few of them on Oprah and you've got a sensational show. Write about them and you've got a headline story.

What you DON'T have is valid science! Statistical analysis tells us that what you experienced is just as likely with or without implants. Any individual case doesn't matter to the mathematics of statistics, which is why it is so powerful in helping us decide what is fact and what is hypothesis. But of course, individual cases matter greatly to us as doctors, and to you, as an individual patient.

You should simply know that to the best of our present scientific knowledge, implants do not cause "strange symptoms," they simply happened to randomly coincide with the use of breast implants. When a patient who does not have implants has "strange symptoms," how did implants "cause" that? And, of course, that happens all the time, for many different medical reasons. Unfortunately, since many internists, rheumatologists, and other physicians are unable to truthfully give an actual "cause" for these symptoms or lab results, but may be aware of the years of controversy (but not necessarily the scientific studies) regarding breast implants, breast implants become an "easy" reason. Some of these physicians may really believe silicone implants cause issues, in spite of the science!

Think about it--if silicone (regardless of what the substance is fabricated into--breast implants, chemo tubing, pacemaker insulation, finger joints, lubrication for needles and IVs, etc.) really caused autoimmune illnesses, then why aren't ALL of these silicone products removed from the marketplace? The answer IS:

There is no autoimmune problem with silicone (of any kind). For more information, click on the web reference link below. Peace and best wishes!

Richard H. Tholen, MD, FACS
Minneapolis Plastic Surgeon
5.0 out of 5 stars 118 reviews

Safety of Silicone Gel Breast Implants

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The answers to your question can be found on the FDA website:

(fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/default.htm)

and the Institute of Medicine report on breast implants:

(iom.edu/Reports/1999/Safety-of-Silicone-Breast-Implants.aspx)

 

While breast implants are not perfect, they are considered safe. As with all medical devices, some problems may occur. However, for the great majority of women who have breast implants, they are happy with the long-term results.

Karol A. Gutowski, MD, FACS
Ohio Plastic Surgeon
5.0 out of 5 stars 17 reviews

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These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.