Patients Raising Doubts About Silicone Injections : Health: The controversial substance is likely to be hot topic at plastic surgeons convention in Newport Beach.

Mildred Beadle didn’t count on this.

In 1968, a plastic surgeon repaired her nose, which had been smashed in a car accident. Almost on a whim, she agreed to also have the creases between her nose and mouth erased with an injection of silicone. It would perk up her appearance, Beadle figured.

Thus began a myriad of medical complications linked to liquid silicone injections, which have not commanded the spotlight as breast implants have in recent months.

“I was fine until eight years later when I started getting lumps” near the mouth, recalled the Westminster housewife, now 69.

Through the years that followed, Beadle suffered through a string of surgeries. One operation salvaged her nose, which collapsed when scar tissue was scraped away. During another, the nerves of her upper lip were damaged, leaving it paralyzed. Today, she uses thick makeup to cover permanent purplish discoloration on her face.

Beadle is not alone. Responding to reports of similar problems, the U.S. Food and Drug Administration has begun to take strong legal action against physicians who continue to use silicone injections as part of their practice, including a Newport Beach doctor.

The federal agency is also receiving an increasing number of inquiries from people who are worried about the broader use of silicone in medical devices ranging from cheek and chin implants to pacemakers and artificial finger joints.

This weekend, the recent FDA crackdown and the growing silicone controversy are bound to be topics of conversation among the hundreds of doctors expected to attend the 42nd annual meeting of the California Society of Plastic Surgeons Inc. in Newport Beach.

One session of the meeting will be devoted to silicone breast implants, a subject much on the minds of not only plastic surgeons, but the public as well.

While silicone injections have not received as much attention as silicone implants, they remain a vexing dilemma for hundreds of women who underwent the procedure during its heyday a few decades back.

Liquid silicone was originally used in Japan just after World War II to enlarge the breasts of geisha girls and other women who wanted to be more attractive to American GIs, authorities say.

The technique was exported to the United States, starting in Beverly Hills, and spread to other parts of the country, including Texas and Las Vegas, in the late 1950s and early 1960s.

During that time, about 50,000 women in the United States, including many exotic dancers and topless waitresses, had their breasts augmented by large injections of liquid silicone, many of them with horrendous results that required their breasts to be amputated.

Then there are women such as Beadle, who had only small amounts of the substance injected to smooth their faces.

Even after years of problems, the Westminster woman worries that the worst may be yet to come. Beadle’s physician has told her that the silicone is causing the tightening of skin and almost unbearable heat that periodically flushes through her body.

Three times since Christmas, such episodes--accompanied by a shortness of breath--have made her rush to a hospital emergency room, Beadle said.

The federal government and the medical community contend there is no scientific proof that silicone of any kind causes such ailments. But women with silicone gel breast implants that have ruptured are reporting similar problems to the FDA.

Although the use of liquid silicone has fallen out of favor with most doctors, cases still crop up.

The FDA recently filed suit to stop a Newport Beach dermatologist from injecting patients with industrial-grade liquid silicone to correct skin conditions such as wrinkles and acne scars. At the same time, the agency also persuaded three New York physicians to stop injecting liquid silicone, which has never been federally approved for medical purposes.

Some argue the FDA should not stop there.

“I honestly think they should look at all the silicone implants used in different parts of the body,” said Gharoon Panahi, a board-certified rheumatologist who practices in Westminster.

Because silicone was long considered biologically inert, it has been used in everything from chin, cheek and penis implants to artificial lenses used after cataract surgery, cardiac pacemakers and catheters and as a lubricant for needles.

Panahi, who has treated Beadle for two years, said he is convinced that silicone is causing the problems with her immune system, which he contends were exacerbated in 1990 when another plastic surgeon used a silicone implant in an effort to straighten her nose.

While some skeptics might contend that Beadle would have developed scleroderma even if she had never been exposed to silicone, Panahi said the way she developed the disease argues against that possibility.

“Ninety-nine percent of the time scleroderma starts in the hands and feet and spreads to the arms and legs. It usually doesn’t start around the mouth,” he said.

In Beadle’s case, the skin tightening and tingling started in the upper lip area where the silicone was injected and only recently spread throughout her body, causing circulation problems that make her hands and fingers cold and numb and turn blue, the doctor said.

“I’m afraid the illness is spreading,” Panahi said.

Sal Liccardo, a San Jose attorney representing more than 200 women who contend that they have gotten immune diseases as a result of silicone gel breast implants, said he believes there is already enough evidence to suggest that silicone should not be used in medical devices. He said his clients also include a man who contends a silicone testicle implant caused systemic disease and a woman who says her immune problems were caused by a silicone thumb prothesis that disintegrated.

“I don’t think it (silicone) should be placed in the body, period,” Liccardo said.

Within the medical community, however, there is strong disagreement about the merits and appropriate uses for silicone. Some physicians swear by silicone gel implants, while a smaller group continue to advocate silicone injections.

Dr. Fred Berkowitz, a cosmetic surgeon with offices in Newport Beach and Anaheim, said he has used liquid silicone injections to correct facial wrinkles and severe deformities since the early 1960s. He stopped only a few weeks ago when it became apparent that the FDA would crack down on such practices.

Berkowitz said he bought his supply of liquid silicone before the FDA took legal action in the mid-1960s to stop the interstate sale of medical-quality liquid silicone injected into the face or breasts.

The doctor contends, however, that the FDA has no authority to control the practice of medicine or regulate his use of liquid silicone.

Moreover, Berkowitz said, the outcome he has achieved with liquid silicone have been “superb.” He said he believes the “horror stories” come from the use of silicone that has been contaminated or administered in doses that are too large.

In the 1960s, he said, some doctors routinely mixed silicone with peanut oil or olive oil because they thought it would speed up the process of filling facial crevices. Moreover, supplies of silicone obtained from Japan were contaminated, Berkowitz said.

Similarly, Dr. F. W. Fancenelli, a cosmetic surgeon who has practiced in Garden Grove for 21 years, objected to the FDA’s moves to stop the use of liquid silicone.

“I think it is insane and the government is totally out of line,” said Fancenelli, who nonetheless added, “I don’t dare use it anymore.”

FDA spokesperson Sharon Snider said the FDA’s current crackdown on liquid silicone was prompted by greater use of injections for cosmetic surgery in recent years, accompanied by vigorous marketing efforts.

But sentiment in the medical community has been turning against the practice because of increased reports of complications in patients, she said. These complications, Snider said, have involved lumps and inflammation, rather than immune disorders such as Beadle’s.

Snider added that the FDA has been able to collect very little scientific information about long-term health effects from the use of silicone medical devices and that more is known about breast implants than anything else.

Dow Corning, a major silicone manufacturer in Midland, Mich., has not sought FDA approval of the material for facial injections, despite “promising” results of two series of trial injections on patients, said Robert Rylee, chairman of the firm’s health care businesses.

Rylee said Dow Corning was concerned that the silicone would be misapplied by physicians without adequate training because “there were no federal laws to regulate who could purchase it.”

Dr. Norman Anderson, associate professor of medicine and surgery at Johns Hopkins Hospital in Baltimore and a member of the FDA advisory panel that has been studying information about silicone breast implants, contends that Dow Corning has not produced sufficient follow-up data on the hundreds of women who participated in the facial injections.

Rylee countered that in one of the company’s studies, 127 patients who received silicone injections to treat severely disfigured faces were followed for a minimum of seven years. While one patient had severe complications and four patients showed no significant improvement, the remainder had “good or excellent” results, he said.

He added, however, that Dow Corning has never advocated the use of liquid silicone, especially in the massive quantities required for breast enlargement.

The development of breast implants that would contain silicone gel in sacs was spurred by the problems with liquid silicone breast injections. But women whose sacs have ruptured have reported some of the same problems, Anderson noted.

Anderson said he has also been contacted by women troubled by facial injections of silicone, which they say have created side effects ranging from extreme pain to recurrent rashes and hardening of the skin.

He does not believe the argument that additives contaminating liquid silicone are responsible for lumps, pain and other complications, Anderson said. “It is a bit like blaming lung cancer on the paper wrapper and not the tobacco,” he said.

It is still uncertain, Anderson said, whether silicone injected into faces and breasts or in the form of silicone gel implants can upset the immune system and cause systemic illnesses such as scleroderma, lupus and arthritis-like diseases. Some have speculated that the women who report such ailments were particularly susceptible or would have developed illness without exposure to silicone.