LATIMES: Silicone implants -- they're still dangerous by Dr. Melmed

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Silicone implants -- they're still dangeroushttp://www.latimes.com/news/opinion/commentary/la-oe-melmed3jan03,0,5050102.story?coll=la-home-commentary

A surgeon who's enlarged the breasts of thousands says that despite FDA approval, silicone implants still aren't safe.

By Melmed, EDWARD MELMED is a surgeon in Dallas.

January 3, 2007

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 a 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. a

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. a'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. 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.