FDA approves silicone breast implants

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.’

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. In fact, silicone is considered to be a very inert compound inside the body. It is used for many types of implants–for example, joint implants and some types of shunts. There can be minor problems when the silicone is injected as a gel to be used as tissue filler because it can be surrounded by a scar capsule. This, in turn, can cause a ‘lump.’ This scar capsule can sometimes contract, or get tight, around breast implants. The scar can cause pain in some patients. This issue was of concern to the FDA.

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?

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 including; some feminists who thought implants were a sexist tool to oppress women, naturists who objected emotionally to anything “foreign” inside the body, medical activists with political agendas and, 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.

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 hearings exposed the fact that there was NO real evidence, only SUSPICION of a link between implants and autoimmune disease, but that there was a small incidence of mechanical ruptures of implants. 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. 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.

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

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