Silicone implants -- they’re still dangerous

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EDWARD MELMED is a surgeon in Dallas.

THE FRIDAY before Thanksgiving, all U.S. plastic surgeons received a congratulatory e-mail from the principal manufacturer of breast implants.

“Let’s toast this monumental occasion,” reads the subject line. Silicone implants are coming back on the market for the first time since they were banned in 1992. Why not celebrate? It’s big money for easy surgery — and a lot of women want to look like the thin but big-busted women they see in lingerie catalogs and on “reality” TV shows. I seem to be one of the few plastic surgeons who won’t be getting out the champagne.

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. Then Paula S. came to see me in 1992. At age 32, she had had at least three breast surgeries, and each time her breasts became rock-hard and painful. She could not lie on her stomach. 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 virtually 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 Food and Drug Administration, under pressure from implant manufacturers, plastic surgeons and patients, is allowing as of Jan. 1 a new generation of silicone implants in women age 22 and over. The new generations of implants, we are assured, are less likely to rupture. However, this claim has been made for every previous generation. To monitor women’s health, the FDA will require women who receive implants to have regular MRIs 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. They, not the manufacturers, will have to pay for the MRIs and replacements as recommended. Most plastic surgeons vehemently deny any connection between health complaints and leaking silicone implants. But I have seen a disturbing number of patients with symptoms, including fatigue, short-term memory loss, joint and muscle pains, 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. According to the manufacturers’ own literature, one in four women has additional surgery within the first year. Many women have multiple surgeries.

“Women deciding to have these implants need to be prepared to have additional surgery,” cautioned Dr. Daniel Schultz, head of the Center for Devices and Radiological Health at the FDA.


The FDA is requiring manufacturers to spend 10 years studying 80,000 women who receive the implants. Apparently our government’s policy has become, “Approve now, test later.” At current implantation rates, these devices will be in the bodies of 5% of U.S. women within a decade. As I now see it, grossly outsized artificial breasts are a deformity that flouts medical standards and even the plastic surgeons society’s own definition of “cosmetic” — all too often encouraged by the media, which celebrates these water balloons for self-esteem.

Though I do approve of the use of implants for breast reconstruction, when there is no other option, I no longer perform cosmetic breast augmentation. But let’s raise a glass of bubbly for the manufacturers and the plastic surgeons. This will be a happy and prosperous year, for them.