FDA ends 14 year moratorium and approves silicone breast implants in 2006

Modified on | by Dr. Ricardo L. Rodriguez

Silicone breast implants are back!

The truth always comes out in the end. In the case of silicone breast implants, it took 14 years! How can it be that implants are supposed to be so bad yet they’re back in the market?

Well, because silicone breast implants were never really ‘bad.’

Silicone implants banned in 1992

For those of you not familiar with the story, in the first years of the 90’s there were stormy currents in society gathering force against the whole idea of breast implants. At the time, there was a newly appointed FDA chief named David Kessler.

He wanted to give the agency a new sense of purpose and clout by taking on a high profile product. To set an example, he contemplated regulating orange juice labeling or breast implants. Orange juice was considered risky as regulatory issues could have unpredictable consequences on consumers (Don’t mess with my OJ!), plus he’d have to deal with powerful agricultural business interests.

Breast implants were considered a better target since its defenders would be ‘rich plastic surgeons’, ‘vain women’, and ‘strippers’. Not fearing a public backlash from such constituencies, the pressure was on at the FDA to put the implants under the regulatory microscope.

Some epidemiologists had looked at a possible link between breast implants and cancer, but no relation had been found. The medical community was not overly concerned, because the general experience with silicone was positive.

Silicone as an element is inert

In fact, silicone is considered to be a very inert compound inside the body. If you look at the periodic chart of the elements it is in the inert column, because it is a stable element. Silicone is used for many types of implants–for example, joint implants and some types of shunts.

Some researchers noticed that a few women with breast implants also had Autoimmune disease, where the body reacts against itself. Was this a coincidence or were implants somehow responsible?

Connie Chung’s interview started the media frenzy with silicone implants

The whole issue of the body reacting to silicone entered into the national consciousness around 1991, with a TV exposé by Connie Chung, a TV personality with no medical background. She interviewed a patient with breast implants and autoimmune disease.

The idea advanced as fact was that the reaction of the body against silicone progressed so that the body now reacted against itself. There was no laboratory proof of this. But the image of a suffering patient in front of the camera had an explosive and emotional impact.

The telecast brought a lot of people together. People, who for various reasons, were against the whole idea of breast implants to begin with . These included feminists who thought implants were a sexist tool to oppress women, naturists who objected emotionally to anything “foreign” inside the body, and medical activist with political agendas. Unfortunately, some patients who were having emotional or health problems and also happened to have had breast implants.

It also attracted lawyers who saw big money potential.

Lawyers , and big lawsuits against the implant manufacturers

The lawsuit industry went into high gear. There was a landmark case in California surrounding an unfortunate woman who, during the lawsuit trial against implant manufacturers, admitted to having symptoms of autoimmune disease BEFORE having her breast implants. Yet she won a multimillion dollar judgement. Truth and logic collapsed before a sympathetic jury.

Lawyers were advertising in mass media about the perils of breast implants, literally fishing for women to come forward with any symptoms as the potential payoff was huge. Experienced lawyers were advertising to other lawyers with “kids” on how to sue on behalf of patients with breast implants.

Mind you, there was NO scientific evidence that breast implants were responsible for any of these “autoimmune” disorders, but it was useful for the lawyers to spread fear amongst patients.

There was mass hysteria, and the steamroller was on to ban breast implants in Congress, with Congressional hearings set. Yet somehow none of the enemies of silicone had stopped to think about Breast Cancer victims who needed breast reconstruction.

Specifically, Nancy Kestenbaum, a senator from Kansas, had recently been diagnosed with Breast Cancer and was contemplating Silicone breast implant reconstruction. All of a sudden, there was a real debate about Breast implants, with a “sympathetic advocate” for breast implants.

To make a long story short, the Congressional hearings exposed the fact that there was NO real evidence . There were SUSPICION of a link between implants and autoimmune disease, but that there was a small incidence of mechanical ruptures of implants.

Hearings propose the need for long term study

Whether the ruptures were a health risk was not known, but the risk was considered to be small. For these reasons the following decisions were made:

  1. Silicone implants needed to be studied to determine rupture rates and to determine if the risk of autoimmune disease was real or not.
  2. Patients with breast cancer, congenital anomalies, or breast deformities could have silicone breast implants. The rationale was that the benefit obtained from the Breast reconstruction out-weighed the unknown risk of autoimmune disease. These patients would then form part of a study to determine if such a risk was significant.
  3. Patients who wanted an elective cosmetic Breast augmentation were not eligible for silicone because it was not considered ethical to subject an otherwise healthy patient to an unknown risk.

Sadly, the “moratorium” on breast implants was publicized by the plaintiff lawyers and accepted by the media as a vindication of the theory that implants are “bad” for you.

Dow Corning went bankrupt with a class action lawsuit

The consequences were devastating to Dow-Corning, an implant manufacturer. A class action suit was brought against it, and the company was bankrupted. The lawyers won a $4 BILLION dollar settlement.

Thousands of women, anguished by the fact that they may have had a “ticking time bomb” in their chests underwent unnecessary surgery to remove their implants. I removed implants or exchanged for saline implants on many of these anguished women. They came to me referred from well meaning primary care doctors, lawyers, or after becoming alarmed by what they had heard or read in the press.

In 2006 the FDA clears silicone implants for elective use again

After 14 years of moratorium on silicone breast implants, the studies found that there was no greater incidence of auto-immune problems than the general population . Thus, silicone implants were allowed back on the market for elective use.

Tomorrow I will post about why I am so happy to be able to use silicone implants again.

(originally posted November 19, 2009)

By Dr. Ricardo L. Rodriguez MD Board Certified Plastic Surgeon Cosmeticsurg Baltimore, Maryland Ricardo L. Rodriguez on American Society of Plastic Surgeons.

Related categories

Related procedures

Leave a Reply

Your email address will not be published. Required fields are marked *

4 thoughts on “FDA ends 14 year moratorium and approves silicone breast implants in 2006”

  • Breast Silicone Implants Augmentation says:

    Silicone implants carried the risk of breast hardening. Do Breast Augmentation Cohesive Gels works better? What is good to try?

    • Dr. Ricardo L Rodriguez says:

      All breast implants, not just silicone carry the risk of breast hardening. The reason for this is that the hardening is caused by the scar that is formed around the implant. If the scar contracts, it shrinks the envelope of the implant until the scar is compressing the fill material itself. It's as if you take a partially filled water ballon and squeeze it. At first the balloon is soft and shapeless, but at a certain point it becomes hard and perfectly round. That is why implants with contracture look so round and feel so hard. The likelihood of contracture has more to do with: 1- implant placement- above the muscle is worse than below the muscle 2- individual variation- some people are more prone to capsular contracture 3-Trauma- Sometimes people will experience capsular contracture after trauma to the implant. Some silicone implants have a stiffer gel, the gummy bear implants by Inamed are an example. Capsular contracture can happen in these implants, it just doesn't distort the implant as much because the implant is stiffer.

  • Karina says:

    I was a doctors wife, received implants in 1985 and became severely ill in 2005. Only after I became extremely ill, 3 months after, it was discovered on radiograph that my lifelong silicone implants were ruptured. I now have a myriad of symptoms, was granted disability in short order as a result of having them in the first place. I must say, strippers and vain women is not a very polite way to describe the wishes of a doctor for his wife after having 5 children. I was told when I received them that I would have them for life. I also happen to be a nurse and find it quite interesting that I was severely symptomatic prior to having knowledge of their rupture. Have been healthy all my life until the discovery of rupture. You can't possibly believe that everyone went after their plastic surgeon because they had deep pockets. My surgeon is dead. I did not jump on the bandwwagon for the Dow lawsuit either. However, I must live in pain, with all sorts of disease processes that were never present before. FDA allowing them back on the market? I can think of more reasons than most why that has occurred but fact is as time goes by there will be controversy again because silicone, its components, and additives are harmful and caustic to the human body. Perhaps you would like to see the MRI of my liver or check out my antipolymer antibody levels.

    • Dr. Ricardo L Rodriguez says:

      First of all, let me extend my deepest sympathies to you. My first cousin has battled fibromyalgia, as well as many symptoms related to autoimmune disorders whose precise diagnosis is not clear. I know you are going through a painful and frustrating process. You raise many issues in your post, suffice it to say the FDA looked at this matter conscientiously and exhaustively for 16 years before allowing the implants back on the market. I was peripherally involved in some aspects of the approval process for the saline implants (which have a silicon shell). I can tell you beyond a doubt that the decision was taken after many delays to chase down any piece of evidence, not matter how small. In the end, the decision was based on very solid scientific evidence. Epidemiologic data from many countries served to confirm that although autoimmune problems can coexist with implants, the relationship is temporal, not causative. I appreciate the time and effort you took to post this, and I hope your disease process can come under control and you find some relief. God Bless you.