Mary McDonough has been working to educate and inform women about the risks of breast implants for over a decade. She have lobbied Congress and worked with the FDA to assure safety and efficacy of devices. Since the FDA approval Mary met with the FDA to follow through with the post market conditions, surveillance and research.
Since I went public with my breast implant problems, hundreds of women have contacted me desperate for trustworthy information about breast implants. Like me, they underwent various operations they were told were perfectly safe, then had terrible problems. To add insult to injury, they couldn’t find out how to get better.
I founded In the Know originally as a support group for women in the entertainment industry who are struggling with these issues with the idea that it is essential that we all get “in the know.” There was such a positive response from so many women, that we expanded to include all women who need to be In the Know.
Over the years I have worked regularly with the brave women who have been affected by implants and plastic surgery. These women have been courageous enough to publicly talk about their problems. We are all unfortunately “In the Know” about the harm breast implants can do.
When I contacted the FDA recently with my concerns, they sent me this statement, “We will be able to give reasonable assurance of safety and effectiveness.”
What does that mean? It doesn’t mean they are safe. What, exactly, is “reasonable assurance?” Especially when the reasonable assurance is coming from the very manufacturers who make millions of dollars from selling implants. How reasonable can their assurance really be?
Since the FDA put their seal of approval on silicone gel implants, they need to be able to assure women that these implants will not harm them. That they will NOT fall apart in the body, that they will NOT turn as hard as rocks, that women will NOT suffer the rashes, fevers, headaches, shootings pains and completely failed health you will read about today.
Let me make one thing clear – I am NOT anti-implant. I AM pro-safety and information. Now that the FDA has lifted restrictions on silicone, I fear we will NEVER have a good, safe implant. FDA – please continue to study the devices and work towards making them safe for women.
Some Facts About Implants
In November 2006, the FDA lifted restrictions on the sale of silicone gel breast implants. They considered LESS THAN THREE years of data.
Less than three years of data? This is absurd for a device women hope will last a lifetime. All of the women here will tell you that their problems began after three years – and many of their health issues got much worse over time.
There’s so much that we DON’T know about silicone gel breast implants – but we DO know that most problems begin YEARS after implantation. I started to have serious problems five years after my initial surgery. Researchers and clinicians agree that problems begin, on average, at seven to ten years post-implantation.
Let’s look at what else we DO know.
- We do know that breast implants do not last a lifetime. They all fall apart in the body over time. When mine were removed, the outer lining was completely missing and the gel was held in place by my own scar tissue. According to the FDA’s own research, at five years, most implants are still intact. At ten years, many are ruptured. By fifteen to twenty years, most are broken. Knowing this, the FDA contradicted its own research by looking at only two to three years of data when it considered approval.
- We do know that women have painful and debilitating complications in the breast area. I had so much pain I could not hold or hug my own child. Once again, according to the FDA’s own consumer handbook, these problems get much worse over time.
- We do know that women with breast implants require many repeat surgeries. The New England Journal of Medicine said in 1997 that one in four women need additional surgery within five years because of problems related to their breast implants.
- We do know that health insurance often does not pay for these repeat surgeries or the replacement implants.
- We do know that cancer survivors suffer at much higher rates from painful complications and require more repeat surgeries.
- We do know that hundreds of thousands of women have been hurt by breast implants.
- We do know that it’s impossible to get a clean mammogram. Implants obscure about 80 percent of breast tissue.
- We do know that silicone gel escapes the implant and travels all over the body.
- We do NOT know the effect of silicone in the body.