FAULTY DEVICES 

Although saline implants have been on the market since the 1960s and now generate roughly $800 million a year for manufacturers and plastic surgeons, the Food and Drug Administration (FDA) did not evaluate them for approval until this year. The initial lack of scrutiny was due to the fact that the implants slipped into the marketplace before the FDA sanction was required for medical devices. However, prompted by nearly 50,000 reports from women and doctors about adverse side effects–including 118 deaths–allegedly related to implants since 1985, the agency finally did order two major U.S. breast implant manufacturers, McGhan Medical and Mentor Corp., to conduct ongoing studies that would establish the safety of their products. Findings from the first three years of the trials and some of the fourth-year data were released at FDA hearings last March. The results surprised many and caused some women’s health advocates to caution strongly saline implants. 

The McGhan study of 1,169 women with its brand of implants found that 60 percent of those who had their breasts enlarged and 84 percent who underwent reconstruction for medical reasons suffered at least one complication within four years. The researchers uncovered a wide array of problems. More than one fourth of cosmetic patients ended up with asymmetrical, wrinkled or scarred breasts, while 8 percent had improperly positioned implants and 17 percent had either intense nipple sensation or numbness. Sixteen percent suffered moderate to very severe breast pain; 9 percent developed capsular contracture, an often painful hardening of tissue around the implants that, in severe cases, causes disfigurement; and another 9 percent had implants that could be felt or seen through their skin. 

Cancer survivors and other reconstruction patients fared far worse: Almost three-quarters had scarring complications, folds, asymmetry or implant positioning problems; 20 percent had visible or palpable implants; and 15 percent were in moderate to very severe pain. In addition, about one in 20 women in both groups had an implant that leaked or deflated within three years. The studies conducted by the Mentor Corp. showed similar results. 
"This is shocking data," charges Norman Anderson, M.D., former chair of the FDA’s medical devices committee from 1984 to 1988 and currently associate professor of medicine at Johns Hopkins School of Medicine in Baltimore. Anderson implored the agency to put a stop to saline implants, testifying that they "have the potential to have the highest failure rate of any device ever approved by the FDA." Despite his pleas (there were 19 speakers, representing both individuals and groups, who testified in support of saline implants; 18 testified against them), they were approved in May. "It’s a horrible situation," he told Glamour. "These devices can deflate if they get a crack the size of a pinhole. I have patients in my practice who have had as many as 14 implant operations." 
The FDA, however, stands by its decision to approve saline implants. "The vast majority of complications don’t affect health but rather the quality of the cosmetic results–such as a lack of symmetry, wrinkling or capsular contracture," contends David Feigal, M.D., director of the FDA’s Center for Devices and Radiological Health. "As with many cosmetic procedures, it’s not unusual to have additional surgery." The implant makers, for their part, maintain that such risks are a small price to pay for the benefits of bigger breasts, all things considered. "The FDA panel voted our product as a safe and effective device that satisfies medical and psychological needs," asserts Ilan Reich, president of Inamed Corp., the parent company of McGhan. "All of our studies show that implants make women feel better about themselves and vastly improve the lives of cancer patients who have had mastectomies." 
 

Yet Cherien Dabis, 24, believes that no amount of bust-boosting confidence is worth the pain her implant caused her. In 1996, the Silver Spring, Maryland, publicist had her left breast, which failed to develop due to a birth defect, reconstructed. First, her saline implant shifted upward, making it noticeably higher than her other breast. Soon after that, she developed chronic breast pain. By January of this year, her breast had become painfully hard, a fairly common complication of saline implants, as shown by the manufacturers’ studies. All of this might have been bearable, but then in June, she says, for no apparent reason her implant ruptured. "I stepped out of the shower and noticed my left breast was gone," she recalls. "It was completely flat. I kept staring at myself in the mirror because I couldn’t believe this had really happened." 

Dabis had to have the implant removed. "What was left of it looked really ugly, like a deflated balloon covered with dark purple, mucuslike slime," she says. "I decided not to have it replaced." 

REPEAT SURGERIES 

One unsettling finding to emerge from the FDA hearings is how often breast jobs have to be redone. The McGhan study showed that more than one out of five women with cosmetically enhanced busts–and 39 percent of cancer patients–need additional surgery within three years. The top reasons for such procedures include replacement of ruptured and leaking implants and alleviation of hardened breasts caused by capsular contracture and other factors. And new implants don’t always solve the problem. After a second surgery, nearly half of cancer patients (whose remaining breast tissue and immune systems may be more fragile due to surgery, radiation and chemotherapy) develop severe capsular contracture, and 26 percent require a third set within two years. 

Kim Green, a 36-year-old homemaker with two children in West Hartford, Connecticut, got breast cancer in 1998, when she was seven months pregnant, and had her breasts rebuilt after a double mastectomy. So far, she has endured 11 operations, at a cost of more than $70,000 (all of it covered by insurance). And with only one implant right now, she faces still more surgery this coming January for the second. Each time implants have been removed, she says, "it’s like having a mastectomy all over again, with total anesthesia and drains in my chest. It’s been devastating–I spent a whole year having surgery almost every month. When I was diagnosed with breast cancer–which killed my mother when she was 35–I just wanted to live. I never dreamed reconstruction could be this bad. It’s worse than chemotherapy." Yet she’s determined to keep trying. Getting her "breasts" back is somehow a symbol that she’s gotten past her disease. "I want to look as normal as possible," she confesses. 

Despite stories like this and the complication rates shown in the latest studies, FDA officials feel it’s ultimately up to consumers to decide what risks they will take. Thanks to the hearings, both implant companies now have new package inserts that detail the study findings, which are also posted on the FDA Web site at www.fda.gov. "Patients can [now] look at the brochures to find out about the experiences of women who have these implants," says the FDA’s Dr. Feigal. "The whole purpose of the FDA approval process was to gather information so patients know exactly what to expect." 

THE EXCRUCIATING PAIN 

When Kathryn Gordon’s black implant was sent for testing to Dr. Pierre Blais, Ph.D., a former senior scientific adviser at Canada’s version of the FDA, Health Canada’s Health Protection Branch, the results were unnerving. "The implant was full of dead fungus–aspergillis [sic] niger, aspergillis [sic] fumigatis and a subtype of the albicans family–which could make the recipient very ill," explains Blais, who has analyzed more than 7,000 breast implants. But he also found something far worse–dead, antibiotic-resistant bacteria: "Enough to fill a teaspoon." 

The bacteria and fungi were dead because the implant had been dunked in formaldehyde upon removal from Gordon’s chest, as is customary–so clearly this wasn’t mold that had grown afterward. "We’ve seen hundreds of cases like this," maintains Blais. "But Ms. Gordon’s implant ranks number four among the most contaminated implants we’ve ever tested." 

In Blais’ analysis, small amounts of the bugs had leaked into Gordon’s body as her implant aged, making her feel sick. When the organism-filled sac was removed, antibiotics and antifungal drugs were able to wipe out the remaining germs in her body and restore her health. "Had the implant stayed in longer, she might have been chronically ill; had it ruptured, her body could have been flooded with bacteria and fungus that drugs would have been unable to fight. She was really lucky to walk away from this," notes Blais solemnly. "If I were her, I would not buy a lottery ticket for a long time." 

Mounting evidence suggests that in a small percentage of women, like Kathryn Gordon, implants become tainted with bacteria or fungus, which sometimes causes the sacs to discolor and, over time, the wearers develop autoimmune-like illnesses. Although the FDA maintains that implants do not cause these illnesses, the agency is planning to review additional reports from the manufacturers’ ongoing studies (which will continue for about six more years). Mentor Corp.’s studies so far have already shown that 2 percent of augmentation patients and 9 percent of reconstruction subjects developed unspecified infections within three years. Six women in each of the manufacturers’ studies were also deemed, using very strict criteria, to have autoimmune problems. 
How could the implants become contaminated? When breast implants are shipped to a surgeon, they arrive deflated; in the office, the doctor fills them with saline solution through a valve. If the conditions aren’t completely sterile–if, for example, the solution is exposed to air–germs could be introduced. Also, some doctors have been known to add ingredients like antibiotics and disinfectants in the hope of preventing infections. These additives degrade in the implant’s solution after years inside the body. In fact, in Gordon’s implant, Blais did find degraded Keflin, an antibiotic, which contributed to the black color. Worse, instead of protecting her it encouraged the growth of bacteria that were resistant to the drug, hence more dangerous. 

Some experts believe that microbes can pass through the implant’s envelope and through imperfect valves. According to this theory, bugs could enter the sacs from the body, and/or germs growing inside could wind up on the device’s outer surface, infect the surrounding tissue and travel into the bloodstream. The idea is controversial, however. "Cases of contamination have been cited in the past, but with today’s sterile techniques, bacteria or fungus should not enter the implant during filling or afterward," contends Diane Hart, program manager of patient services at Mentor, the company that made Gordon’s implant. 
Meanwhile, Blais, who has authored 250 scientific papers on the safety of implantable medical devices, believes women are still in danger. He has seen hundreds of black, brown and green implants–both saline and silicone-gel implants, which were banned for cosmetic use in 1992 but allowed for reconstruction patients–removed from women who had all types of health problems, including autoimmune symptoms. These colors correlate to certain types of microbes present in the implant, he explains. "One of the most common contaminants in black implants is aspergillus niger, a black variety of fungus, while two other forms, aspergillus fumigatis and Bouffardi’s black, cause dark brown discoloration." In the case of blue or green implants, the culprit is usually algae. 
V. Leroy Young, M.D., professor of plastic surgery at Washington University in St. Louis, is another scientist who has shown that disease-causing microbes including E. coli, staph bacteria and aspergillus can grow in saline implants. Further, a handful of studies have shown a connection between symptoms associated with autoimmune disease and germ-ridden implants of both the saline and silicone variety. 

In one of these studies, Marek .K. Dobke, M.D., head of the division of plastic surgery at the University of California, San Diego School of Medicine, cultured both kinds of implants, removed from more than 300 hundred women complaining of muscle or joint pain, chronic fatigue, skin rashes, low grade fever, dry eyes and mouth, hair loss, and confusion or impaired memory. He found bacteria (most commonly staph) or fungi in approximately 70 percent of cases–three times the rate of occurrence of bugs in implants removed from healthy women who were having an "explant" for cosmetic reasons (such as trading up a cup size). He also found high rates of microbe contamination in women with capsular contracture and breast pain–a connection that many agree with, including Dr. Young, who fingers bacteria as the culprit. "This strong correlation between microbes–mostly bacteria–and symptoms," maintains Dr. Dobke, "may be the key to the health troubles so many women with implants have." 

Still, many experts discount such findings. Dr. Young, despite his own microbe studies, contends that the real discoloring culprits in most cases are the substances often added to the saline fill, such as Betadine, an antiseptic, which is brown. He’s also suspect of research finding live germs in contaminated implants. "If the device has been sitting around in someone’s closet, you may find fungus, but that doesn’t mean it was there when the implant was removed," he contends. 

Others believe that implant patients’ autoimmune complaints are coincidental. "Women are genuinely suffering [from autoimmune problems]," explains James L. Baker Jr., M.D., clinical professor of plastic surgery at the University of South Florida in Tampa, "but women who have implants have the same rate of these diseases as those who don’t." Dr. Baker also points out that people who have other kinds of implantable devices in their bodies aren’t complaining of an autoimmune epidemic. But this is another point of debate. Small studies by Dr. Dobke and others have shown a link between painful symptoms in men and contaminated penile implants. Blais adds that because implants are soft and fluid-filled, they may provide a more conducive environment for germs to grow than, say, a hard chin implant or knee replacement. However, he admits, a dearth of research on other types of devices leaves many questions unanswered. "With many medical implantable devices," he notes, "the patients are elderly, so autoimmune problems that take time to develop may not show up before a patient dies or may never be linked to the implant."

 
A PERSONAL DECISION 

Not all scientists who believe that implants trigger autoimmune disorders finger microbes as the culprits. Many, despite substantial scientific evidence showing otherwise, steadfastly claim that silicone is to blame. "Many women don’t realize that saline implants are surrounded by a silicone shell, just like the one that surrounds silicone-gel implants," points out Frank Vasey, M.D., chief of rheumatology at the University of South Florida. 
A more tangible area of concern, acknowledged by almost everyone in the medical community: Implants may make it harder to detect breast cancer. One reason is that cancer cells can be confused with calcifications around the implant on a mammogram. Also, the sizeable sacs may obscure lumps one would normally notice in a self-exam. "This is very scary," charges Diana Zuckerman, Ph.D., president of the National Center for Policy Research for Women and Families in Washington, D.C., "because cancer may be missed or diagnosis delayed until the disease reaches a later stage, when it’s less curable." 

Women need to push their doctors to be up-front about the risks, cautions Zuckerman, because some may downplay any bad news that could deflate their profits. And the FDA approval should not put you at ease, she warns: "To call saline implants safe on the basis of three- or four-year studies paid for by implant manufacturers leaves women dangerously in the dark." That’s why if you’re considering surgery, it’s crucial to check the FDA Web site (www.fda.gov) to learn about possible side effects and discuss them in depth with your surgeon. "Getting implants is a lifelong decision, because even if you later have them removed, your breasts will never look as good as they did before the operation," she stresses. 

Ultimately, says Dr. Kolb, the Atlanta plastic surgeon who removed Kathryn Gordon’s implants, it’s up to women to make up their own minds–a conclusion shared by most medical professionals. Despite falling ill herself with unshakable fatigue, dizziness, muscle aches, numbness in her arms, dry eyes and memory problems after getting silicon[sic]-gel implants, Dr. Kolb continues to augment other women’s breasts, with saline, and now is delighted with the salt-water pair she wears herself. "How can I be totally against something I have in my own body? I agree there’s vast room for improvement, but as long as women are fully informed of the risks. Why can’t they decide for themselves, as I did?"

ADDITIONAL REPORTING BY DINA ROTH 
Saline Sound Off! 

Here, two experts duke it out over saline implant safety. 

THE PROS

LORI SALTZ, M.D., is a plastic surgeon in La Jolla, California, who has had silicone implants for 24 years and believes silicone and saline implants are safe. 

ON THE DANGERS OF INFECTION / DEFLATION: While there is a risk of infection in any elective surgery, I only fill implants with sterile saline through a closed system–from the IV bag through a sterile tube into the implant. If an implant deflates, your body will absorb the solution, which is the same as what’s in an IV bag at the hospital.  

ON THE CONNECTION BETWEEN IMPLANTS AND AUTOIMMUNE DISORDERS: There’s no proof to justify pinning the autoimmune complaints on implants. A million other things could be causing these symptoms. I haven’t seen any of these problems in my practice. 
 

BOTTOM LINE: I’m not saying everyone with breast implants is going to be happy. I see some women whose scar capsule around their implants contracts and hardens when we put them in. But it should be a woman’s choice, not the government’s decision.

THE CONS

ILENA ROSENTHAL is director of the Humantics Foundation for Women, Breast Implant: Recovery and Discovery in San Diego. 

ON THE DANGERS OF INFECTION DEFLATION: The labels on 1-liter bottles of saline IV solution recommend storage at 77 degrees and include a discard date of about 18 months. With implants, the saline is stored in your body at 98.6 degrees for years, which, I believe, makes it a very good medium for fungi and other microbes to grow. I’ve run across a lot of women who have saline implants and symptoms of subclinical infections. 

ON THE CONNECTION BETWEEN IMPLANTS AND AUTOIMMUNE DISORDERS: I think the saline implant’s silicone shell could cause systematic (sic) [read: "systemic"] reactions in some cases. Women with saline implants complain about the same autoimmune problems that those with silicone-gel sacs did. 

BOTTOM LINE: I’ve seen thousands of women who got implants suffering healthwise. I just want anyone thinking about enhancing her breasts to realize that the risks are very real and serious, and that the complication rate is extraordinarily high.