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"I have this sinking feeling that after the victory handed to medical device manufacturers on a silver platter by the United States Supreme Court decision in Riegel v. Medtronic, they are in need of even more oversight and circumspection." - Michael B. Mundorff 02/08/09



February 2008

United States Supreme Court rules that any medical device manufacturer whose medical device has been approved for use by the FDA may not be sued even if the medical device fails to perform as advertised.




"I have enlarged the breasts of thousands of women with silicone implants since they were first introduced in the 1960s.

I even wrote articles in favor of silicone.

Paula S. came to see me in 1992. At age 32, she had at least three breast surgeries, and each time her breasts became rock-hard and painful. We replaced the silicone with smooth saline implants. Within a short time these too became hard, as did the next set. Paula insisted on having her implants removed. She would not heed my warnings about deformity and scarring, which we had all been told inevitably follows removal without replacement. To my surprise, she looked terrific - normal, albeit smaller - and she felt better.

Paula's problem turned out to be common: Most breasts with silicone gel implants become hard with time. It's called capsular contracture. All foreign objects in the body get encapsulated - just as the tissue around a splinter gets hard - until the foreign body is removed. Women with capsular contracture often end up with disfigured breasts and pain.

Recently I saw Helen S., 71, who had implants 23 years ago. Her breasts also had hardened and become painful. In addition, an MRI showed rupture of the implants and calcification of the surrounding scar tissue. When I removed the implants, the cavity was filled with gooey, liquid silicone that had ruptured; there was virtualy no implant wall left.

In the last 14 years, I have removed implants from almost 1,000 women.

I have found roughly 50% of their implants have ruptured within 10 years, and more than 70% have ruptured within 15 years.

We are still not sure of all the places where the micro-droplets of silicone end up, though I have found it in lymph nodes.

Despite these known hazards, the FDA, under pressure from implant manufacturers, plastic surgeons and patients, is allowing as of January 2007, a new generation of silicone implants in women age 22 and over.

To monitor women's health, the FDA will require women who receive implants to have regular MRls and has recommended that the implants be replaced every 10 years.

It is a pity that women will become the experimental lab rats for these implants.

Most plastic surgeons vehemently deny any connection between health complaints and leaking silicone implants.

I have seen a disturbing number of patients with symptoms, including fatigue, memory loss, joint pain, muscle pain, skin rashes, disturbed sleep patterns, depression and hair loss, that clear up when implants are removed.

Last year, I completed a review of the last 500 gel implant removals I performed, and found that more than half the women had similar symptoms, ranging from mild to debilitating.

Grossly outsized artificial breasts are a deformity that flouts medical standards and plastic surgeons definition of "cosmetic" - often encouraged by the media, which celebrates these water balloons for self-esteem. I no longer perform cosmetic breast augmentation." - Edward Melmed, MD


Women seeking breast implants have a higher-than-average risk of underlying psychological problems.

Women with breast implants are three times more likely to kill themselves according to British Medical Journal.

"The slippery slope is if you go to a surgeon to solve self-esteem problems they will not be fixed." - Psychiatrist Mark I. Levy, University of California, San Francisco


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