Gummy Bear Breast Implants

Perfecting Bodies Through Chemistry?

February 22, 2013 Written by Diana Zuckerman  FiDA highlight

Do you like your body?   If there was a simple way to change it, with no risks, would you do it?

If making that change meant you would put your health at risk and have multiple surgeries for the rest of your life, would you hesitate?

Most women say they don’t like their bodies, and research shows that dissatisfaction usually starts during the middle school years and may never go away.  For many of us, it eases up a little in young adulthood as we come to appreciate our attributes and accept any “flaws,” but insecurities rev up again as aging takes its toll.  It seems ironic that we long to regain the body that seemed so imperfect when we were younger.

In the U.S., there are thousands of products and procedures that feed on women’s insecurities.  Most are ineffective – the pills and products that promise to melt fat away without diet or exercise, or to make cellulite or wrinkles disappear.  But only a few are actually dangerous to our health.  Breast implants are one of those.

The FDA just approved a new kind of breast implant, which many plastic surgeons promise will be safer and better than other kinds of breast implants.  It is made of thick silicone gel (nicknamed “gummy bear implants” for its consistency), which is supposed to prevent it from breaking, leaking, or wrecking havoc with your body.

What’s the proof that this product is safer, or even safe at all?  Apparently, that’s a secret.

When breast implants were first sold in the U.S. in the 1960s, no testing was required to make sure they were safe.  For the next 30 years, more than a million women in the U.S. got breast implants, not realizing that studies on women had never been done to prove they were safe or to determine how many months or years they would last.

In 1990, I was working as an investigator in the U.S. House of Representatives when a Senate staffer called me.  She told me that her mom had gotten breast implants after a mastectomy, which had resulted in terrible problems including silicone leaking out of her nipples.  Her mom was cured of cancer but the implants had put her through hell.  I was sure that the FDA had very strict rules about safety testing, but I promised I’d look into it.

I found out that I was wrong: the FDA had never required clinical trials for breast implants.  We held a Congressional hearing, I continued my investigation, and soon my office – and the media – was full of horror stories about women whose health had been ruined by breast implants.

Thanks to Congressional and media pressure, the FDA changed their policies.  They eventually required breast implant companies to conduct studies on hundreds of women with breast implants, to find out how safe their products were.  Public meetings were held so that women could testify about their experiences, scientists could openly discuss the research, and the media could report what was said.  Some companies failed to do the newly required research and their implants were no longer allowed to be sold in the U.S.  And, although all breast implants were found to have high complication rates, the FDA, under tremendous pressure from implant companies and plastic surgeons, decided that women were capable of making an informed choice about the risks they were willing to take.

I have no doubt that women are capable of making an informed choice.  But the FDA is still not providing the full information that women need to make an informed choice, and neither are the plastic surgeons.

In a giant step backwards, some FDA officials are reverting to their old ways.  They approved “gummy bear” implants with no public meeting and they have not made the study findings public.  Instead, in a press release that the agency quietly released on February 20, they report that the new breast implants have the same kind of complications as other types of implants – such as hard, painful, or lopsided breasts and the need for additional surgery – but don’t say how often those complications occur.  They also reported a new complication: the silicone gel in these new implants can crack.  What happens to women when that happens?  The FDA isn’t saying.

Since I did my investigation in 1990, I have been one of the FDA’s strongest critics and biggest fans.  I have often been horrified by some of the decisions FDA makes to approve unsafe or inadequately tested medical products, but I also know that when the FDA does its job well, it can save millions of lives.

When I did the Congressional hearing on breast implants, I was 7 months pregnant.  My son is now a college senior.  In those 22 years, the FDA regained and is now again at risk of weakening its public health focus, as Congressional pressure on the FDA to protect patients has been replaced by Congressional pressure to get products to market as quickly as possible and thus “create jobs.”  Whether it is breast implants, riskier birth control pills, TB drugs that do more harm than good, or sleeping pills with questionable benefits, the FDA is allowing drugs to be sold that do a lot of harm.  And when the FDA fails to hold medical products to a high standard, it is women – the consumers of most medical products – who are harmed the most.

For more information about the FDA’s recent decision on Allergan breast implants, see Statement of Dr. Diana Zuckerman on FDA approval of new Silicone-Gel Breast Implant Natrelle 410 and for more information about the risks of breast implants, see www.breastimplantinfo.org

Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD in psychology from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School.  After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House.  She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, and in newspapers across the country.