Breast Implant Clients Face Maze of Conflicting Claims : Health: Are the silicone sacs harmful? What procedure is best? Women get little impartial guidance.


“Hoping to meet guys,” two 23-year-olds--call them Sue and Gail--were driving to Palm Springs for a mini-vacation. “We were laughing about men and what they liked,” Sue recalls, “and in the process I made a couple of ‘flat’ jokes about my breasts or the lack thereof.”

Suddenly the conversation turned serious and Gail said: “You can fix that if you want to, you know--I did.” Sue surveyed Gail’s breasts and was impressed: “They were wonderful--and just what I wanted! I took the name of her doctor and, two weeks later, I had new breasts, too.”

That simple.

Now, eight years later, Sue’s breasts have hardened somewhat despite the exercises she performed in the privacy of the company restroom, an inconvenience cheerfully accepted: “Your breasts don’t feel as ‘normal,’ but they look great.”


Yes, she is alarmed by persistent news reports of silicone leaking dangerously into the body from the implants. And she cannot understand why the Food and Drug Administration only now, 2 million altered women later, is requiring the manufacturers to prove their products safe.

She also knows that an implant can interfere with the detection of breast cancer through mammography, but has been told that some radiologists have developed compensating techniques.

Sue admits that she experienced more pain and inconvenience after the operation than she had been led to expect.

And she is angry that her doctor attempted to collect on a fraudulent insurance claim in her case and was not forthcoming about the risks and pain involved.


Trying to Measure Up

Having said all that, Sue regrets only not having gone for a larger size.

“If, after I have kids, I have to go through this experience again to even them out,” she says, “people are going to notice. This time, I’ll take the Cs please.”

Sue, an aerospace project manager who didn’t want her real name used for fear of embarrassment at work, is not silly or frivolous--but neither are breasts in this culture. She is merely being candid about the enduring torment of women forced to measure up to the dominant fashion fetish of their time: “You worry a bit about what’s inside of you that’s not natural, but you trade that off for looking good in a bikini and having cleavage,” she said.


A common choice these days. In fact, future archeologists digging up millions of non-biodegradable silicone sacs along with silicone chins, cheeks, buttocks and dozens of other implants might well mark it as a distinguishing feature of the era.

After all, women’s breasts used to be or not be. They could be pushed up, padded, or in other ways exaggerated to satisfy the demands of fashion and male obsession, but the breast itself was thought to be immutable. Then along came a multibillion-dollar medical industry promoting the creation of precisely that size and shape the client might desire--for a price.

“When you get your breasts done and you pay, $3,000, $4,000, it’s not that much,” notes Dr. Malcolm Paul, an Irvine plastic surgeon who pointedly observes that his prices are lower than in Beverly Hills. “It’s half of a new Hyundai, but you probably get more mileage.”

Paul reports few dissatisfied customers after more than a thousand such operations: “Today’s the start of my 17th year here and I know I’ve never gone back and made them smaller.”


Breast enhancement has been an emerging art for at least four decades. In the late ‘50s, the Japanese were injecting silicone, and some primitive implants were being used. But as a mass commercial phenomenon, enhancement most likely began back in 1964 with Carol Doda and her soon-famous 44 double Ds.

Twenty silicone shots directly into the breasts of the San Francisco topless dancer turned a 24-year-old, well-proportioned cocktail waitress into a much-publicized spectacle soon emulated throughout the world. The event was generally treated in the media as great fun, but the dancer had been exposed to what experts even then knew to be a dangerous procedure and one that is now illegal.

Since 1963, sacs have been employed to keep the silicone gel from migrating throughout the body in disruptive ways, and the practice has moved from the realm of the bizarre to the respectable. In the booming cosmetic surgery trade, no procedure is more lucrative or controversial than breast augmentation.

Safe or Dangerous?


Are modern breast enhancement procedures safe or dangerous? All experts agree that they should be described as major surgery, that anesthesia is required, and that, as with any such operation, serious complications and even death can occur.

This can happen even with highly trained, board-certified plastic surgeons, as with the case of Dr. Edward J. Domanskis of Newport Beach, currently under review by the state attorney general at the request of the Medical Board of California. In that case, the patient, a 35-year-old mother of four, was discovered unconscious in the recovery room of the doctor’s office after routine breast augmentation surgery. She was taken by ambulance to a nearby hospital and died four days later. Family members charged that she had been improperly monitored.

There have been other fatalities, but exact numbers are difficult to obtain because California, like most states, does not maintain statistics on deaths related to medical procedures. Local coroners will be informed, but they do not pass on the data to state authorities. In any case coroners tend to report the cause of death as cardiac arrest without indicating whether it happened in the course of cosmetic surgery.

Responsible physicians routinely warn patients of the risks. There is, however, no common agreement on which procedures and implants are safest, and the patient is most often left wandering through a maze of competing claims in slick commercial advertisements. The choices, as bewildering as they are serious, were summarized by Dr. Lawrence N. Seifert, a leading Los Angeles surgeon:


“The patient and the surgeon have the option for three locations of an incision: the armpit, the nipple and underneath the breast; two locations of the implant: behind the muscle or above it; and five or six types of implants. You have 25 or 30 choices. Every one of these decisions has its own set of advantages and disadvantages and they need to be weighed on the scale of decision making.”

Seifert, a spokesman for the American Society for Aesthetic Plastic Surgery, has performed this and other cosmetic procedures for more than 20 years. He says today’s implants are safer and the techniques better than ever before, but acknowledges that the patient will often be at a loss to make difficult choices among competing medical claims.

One thing is clear: during the past 20 years as women made choices about breast augmentation, regulatory authorities--state and federal--did nothing to provide them with impartial information about safe and wise procedures. They could not turn to the government for reliable information about which implants to use, the method of insertion and the location in the breast area, each of which is fraught with serious medical implications.

To date, most public attention has been paid to the risks associated with the implants themselves and they have recently been the subject of much media attention and Food and Drug Administration review.


Although 2 million American women have them, and American medical technology has made them common throughout the world, no one seems to know for sure whether these squiggly bags of silicone (or, less commonly, saline solution) are harmful inside the body and, if they are, just why.

The FDA, in effect, ignored the matter for 12 years until it ordered a comprehensive safety review in 1988 under pressure from congressional critics and patients’ rights groups. In April of this year, the agency ordered the manufacturers to supply proof of their products’ safety.

It was only in September that the FDA, through Commissioner David A. Kessler, finally issued a serious warning: “Women need to be urged strongly to consider the risks of these implants . . . the implants have been on the market a long time and women have been lulled into thinking they are risk free. They are not.”

This year, when the agency finally got around to requiring the manufacturers to document the safety of their implants, one leading company, Bristol-Myers Squibb closed down its implant line instead. It advised doctors to cease using its polyurethane implant, which has been linked to carcinogens in some laboratory studies.


The FDA accepted the preliminary applications of four manufacturers, rejected the rest and must decide by Jan. 4 whether it will permit the products to continue to be sold.

The Debate Builds

In the meantime, there has been much lobbying for and against implants, both before Congress and in the media. Critics of the implants have marshaled a list of patients to describe the dreadful consequences to their health they attribute to silicone leaking and spreading to other parts of the body.

They argue that, as a result, some patients have experienced excruciating pain from connective tissue disease. Others claim that leaking silicone has caused cancer. While silicone injected in huge amounts in rats in a laboratory has proved carcinogenic, there is no proof that it is a threat to humans. Implant manufacturers and surgeons who specialize in breast enhancement insist that the negative anecdotal evidence represents a statistically small proportion of implants and that the supposed consequences can often be attributed to other factors.


Recently, the controversy reached crescendo proportions, with the FDA hinting at severely restricting the sale of, or even banning, the implants altogether. In hearings before the FDA in Washington this past November, seven women testified about the painful consequences to their health of leaking silicone.

Media accounts stressed their stories, but tended to overlook the upbeat endorsement provided by 44 other women who had received implants, some after mastectomies, and who called them important to their self-esteem. The arguments of some medical experts that the implants had not been properly tested were countered by a larger group of doctors and drug company representatives who contend that they are besieged by an irrational campaign mounted by know-nothings abetted by excessively litigious lawyers. Current odds lean toward the FDA simply requiring the manufacturers to collect more data, but the matter may be resolved in the courts.

Court cases are piling up on behalf of women who claim they have suffered dire consequences from the breast augmentation procedure. A recent article in a leading trial lawyers’ magazine speaks of “an estimated 40% complication rate” and suggests that women who have received the implants may have much to talk to lawyers about.

Surgeons who perform the procedure, and many other medical experts, consider such charges absurd. They argue that the implants are safer than ever, that the complications refer mostly to the hardening resulting from the natural formation of scar tissue around the implant, which may be painful but is not generally medically threatening, and that true health risks are extremely low.


The known risks involve hardening of the tissue around the implant, the possibility of rupture of the implant and leakage through a process called gel bleed. Proponents of the implants insist that while those effects might be unsightly, they are not dangerous.

The safety of the silicone implants, while highly publicized, is not the only serious issue, as is made clear by the necessity to sift through competing claims about where to cut into the body and the best site for resting the implant. Because the FDA is authorized only to evaluate the safety of the implants themselves, questions of proper medical procedures or the qualifications of surgeons are not regulated. Decisions are left to the consultation between patient and doctor, and government, prodded by the well-organized medical lobby, has been loath to intervene. Yet those issues go directly to the question of comfort and safety.

“It’s not a perfect operation. The patient should hear that loud and clear,” Seifert says.

Of the three possible incision points: under the arm, the fold at the bottom of the breast and the nipple, the last effectively hides the scar, but necessitates getting a rather large object through a small opening.


Most surgeons still prefer the fold incision since it provides the easiest and most visible access to the area where the implant will be placed. But it also leaves the most visible scar.

Dr. Thomas Stephenson, a West Los Angeles surgeon, champions the incision through the armpit.

“I’ve done over 3,000 and I feel good doing them,” he said. He prefers it because unless the arms are raised, the scar will not be noticed, although it tends to be a bigger scar than in the other two locations.

His frequently placed ads in The Times headlined, “Every breast enhancement we perform is missing something,” referring to the scar, are criticized by other surgeons who feel that he is ignoring the trade-off. In the underarm technique, the surgeon’s vision is quite limited, they contend, though Stephenson disagrees.


“It’s a blind dissection,” says Seifert who uses the procedure only infrequently because, “in my experience, the technique of the dissection through the armpit, particularly in younger patients, has a higher rate of asymmetry with dislocation of the implants.”

Hardening Affected?

Seifert and other surgeons claim that it is difficult to place the implant under the muscle using the underarm incision. They favor cutting into the underfold of the breast and placing the implant totally under the muscle. It is thought that placing it under the muscle allows it to be massaged constantly by the muscle’s movement, mitigating against hardening or “encapsulation,” referring to the natural effort of the body to enclose and protect against a foreign object. This hardening can be quite unaesthetic and painful, and if excessive, can crush the implant, causing leakage and necessitating surgical removal.

Paul, the Irvine surgeon, who claims 1,000 breast implants, is a fervent believer in the under-the-muscle technique and reports that with over-the-muscle implants, “40 to 60% of the breasts got firm. . . . We used to see a lot of those breasts that were pushed up and had the scar around them and that was obvious, but with the implants beneath the muscle and with the textured implants it’s different. . . . Over 90% under the muscle stay soft. Years later they’re still like butter.”


A rougher or textured surface on the implants is known to work against the formation of scar tissue. Good results were reported with polyurethane coating, but there was suspicion that the coating itself might be carcinogenic. Recently, they were voluntarily withdrawn from the market by the manufacturer.

Currently, texture is provided by a rippling effect on the silicone surface of the implant sac. Hardening is down but there are complaints that the texturing causes a noticeable rippling of the skin itself.

The under-the-muscle technique is not generally considered effective for patients experiencing sagging of the breasts. Aesthetically, it is not possible to attain as much projection of the breast as with the over-the-muscle-implant. Also some doctors claim that with the under-the-muscle technique when a women flexes her muscles it can squeeze the implant and push it up or toward the side. Some argue that placing the implant under the muscle necessitates severing part of the muscle and impairing its functions. Despite these drawbacks, statistics provided by the professional societies indicate that about 70% of doctors are now using the under-the-muscle procedure, but the controversy is not fully resolved.

In most doctors’ offices, there are thick scrapbooks illustrating the negative effects of procedures rejected by that particular doctor and beneficial ones flowing from his chosen method. All one knows for sure is that the failed procedures can look grotesque, as is evidenced in the photos doctors routinely show patients to illustrate the negative consequences of alternative procedures.


What is a patient to do when starkly different views are offered by highly trained professionals arguing the merits of their own approach? The most common advice is: “Check with friends who have had the operation.” But that may not be enough, because trouble may show up only much later.

Dr. George Brennan, a Newport Beach surgeon, mentioned a recent case in which a woman whose breast implants had been placed by another doctor nine years ago came to see him. One of her breasts had suddenly hardened and she was in considerable pain. His best explanation is that this might have been triggered by an infection caused by a severe bout of the common cold.

As a precaution against hardening, Brennan recommends an exercise to all of his implant patients which involves lying on the abdomen for 15 minutes and vigorously moving the arms. He also suggests using a device called “Sta-sof,” advertised in the cosmetic literature. According to its inventor, Valerie Reid, it is “a clamp that goes behind the breast and compresses it to give continuous and consistent stretch pressure.” She developed the device, she said, because “I would see women trying to massage their breasts with long nails--and they didn’t have the necessary strength in their hands to stretch out the scar,” that forms around the implant.

Expert Skeptical


A federal epidemiologist, who has advised on congressional investigations and who asked that her name not be used, is skeptical of the claims of progress in dealing with the complications arising from breast augmentation. She observes that every few years a new technique is developed that is said to deal with the problems of the old one. But then that method engenders its own complications and some other method is found.

Recently, there have also been a series of successful lawsuits against implant manufacturers. Earlier this month, a federal court jury in San Francisco ordered Dow Corning to pay $7.34 million to a woman whose silicone breast implant ruptured, causing what she contended was a painful disease of the immune system. The case is on appeal, and the company denies that there is any evidence linking the disease to the implant.

After years of steady growth, the market for breast implants has been hard hit by unfavorable media reports. But an even more damaging factor has been the economic recession. “I would say that business went down 25% or more--in some places, a lot more,” reports Irvine’s Paul. “New York City is a very depressed market now. But, it comes back as the economy rebounds. It’s discretionary income. It’s a new car, a family vacation, or a set of breast implants. It always follows that way, same as the car market, or the jewelry market.”

Paul is not being flippant, but as with other serious and professional surgeons, an inevitable commercialism creeps into his discussions about a procedure that involves purchasing breasts as a status symbol.


Nowhere is this more true than in Southern California. “We are a culture that is very much breast-oriented,” Paul observes. “That’s why it’s very popular here. If you go to the beach and everyone else is filling a C cup bathing suit and you’re filling an A cup, I don’t think it would be unusual to feel self-conscious.”

This socially induced feeling of being self-consciously inadequate is clearly basic to the rampant growth of the field of cosmetic surgery for both women and men. But while critics may bemoan such a mechanical measure of meaning and beauty in life, it remains a painful reality for those who, in increasing numbers, are choosing to undergo surgical procedures that carry serious risks.

As for Sue, who eight years after her operation wants Cs instead of the Bs her surgeon gave her, the choice is real, if depressing.

“Our society places so much value on the female figure that health issues take a back seat to fulfilling the fantasy and being accepted,” she said. “Ideally, we should change the way that society views and values women.”


But in the less than ideal world that she inhabits, she resents being told not to have the implants and views it as very much a matter of personal choice whether “I forge ahead with a keen mind and a flat chest, or succumb to the pressures of society and buy a set of breasts like new silverware.”

Times researcher Nina Green contributed to this story.