Tuesday, November 11, 2003


Scientists are working on a new technique that may allow women to grow natural, new breasts, starting with injectable implants.

The concept involves using a woman's own normal, healthy fat cells and growing them in a lab dish on a scaffold of tiny, degradable beads. The cells and scaffolding would then be mixed with a thin gel, and injected through a syringe into the patient's chest. The scaffolding would eventually break down and leave the body through the kidneys. The transplanted cells, meanwhile, would replicate and form new tissue.

The technique is being developed to help reduce the emotional trauma and scarring of breast cancer surgery. But some companies are already eyeing it with something entirely different in mind: The first biologically based implants for women who want larger breasts.

If it works, it could give new meaning to that old question, "Are they real?"

The injectable implants could avoid risks associated with other breast-implant operations, such as infection, bleeding and blood clots. In theory, there would also be no risk of rejection, "because the woman's own cells are used," says lead scientist Karen Burg, a professor of bioengineering at Clemson University in South Carolina.

The injectable implants would also form to any size or irregular shape to fill an area damaged by breast cancer surgery. The transplanted cells would stop growing once they became densely packed. "When they sense they have neighbours, they stop growing."

The biodegradable materials would be broken down into small, dissolvable units and removed in urine. "Most of the materials that we are focusing on break down into products already found in the body, such as lactic acid or collagen, for example, or that are used in the food industry," Burg says.

She says much of the groundwork has been done. "Once a company picks it up, they're on the fast track."

If the biological implants eventually reach the market, it would be a new option for women seeking implants.

"They wouldn't have to have something synthetic [in their body] that would always be a continual worry to them."

More women than ever are seeking breast implants, with some even taking out bank loans and forgoing home renovations in pursuit of a bigger bust, according to a British poll reported last week.

In Canada, demand is growing just as a new study suggests many women end up having their implants permanently removed because of complications, and as Canadian and U.S. officials consider easing restrictions on a controversial silicone breast implant that was pulled from the open market 11 years ago.

Two weeks ago, researchers with the British Columbia Centre of Excellence for Women's Health reported women who undergo breast implant surgery visit the doctor more often, see specialists more often and are hospitalized more frequently than women without implants. Forty per cent of the 92 women who responded to a follow-up questionnaire had their devices taken out. Most of the women in the study had silicone-gel filled implants.

Some critics are extremely dismissive of the research. Dr. Claudio De Lorenzi, a plastic surgeon in Kitchener, Ont., says the results were clearly biased, because the women in the study who had breast implants were partly recruited through public service announcements in community newspapers.

"Women with breast implant problems would be more likely to participate," argues the past president of the Canadian Society for Aesthetic (Cosmetic) Plastic Surgery.

He and other surgeons say the number of women who reported having their implants permanently removed does not fit with what they see in their own practices.

"I've done over a thousand breast implants [using saline implants] and 170 of the [silicone] gel. I should have pulled out 400 sets of implants. That's just not true," De Lorenzi says. "I may have pulled out two dozen or so, but I haven't pulled out hundreds."

One week later, the chair of a U.S. Food and Drug Administration advisory panel that narrowly voted in favour of lifting a ban on silicone gel-filled implants urged the FDA to ignore his panel's "misguided" ruling and reject Inamed Corp.'s application to resume marketing silicone implants.

(Inamed is also seeking Health Canada approval to make the implants widely available in Canada.) Dr. Thomas Whalen argued in a letter to the FDA that the long-term safety "was clearly not demonstrated", the Associated Press reported.

Whalen's panel met just as U.S. and Finnish researchers reported the results of a study that found a three times higher than expected rate of suicide among women who had breast implants. Researchers tracked almost 2,200 women who underwent cosmetic breast implantation in Finland from 1970 to 2000.

Over-all death rates were actually slightly lower than expected. But the suicide rate was statistically significantly higher than expected, and was highest during the first five years of follow-up.

Mental health experts were quick to caution that any psychological problems were likely to have existed before the surgery.

Dr. David Sarwer, of the University of Pennsylvania School of Medicine's Center for Human Appearance in Philadelphia, told a gathering of science reporters that up to 15 per cent of women who have plastic surgery suffer from body dysmorphic disorder, a preoccupation with imagined or slight flaws in appearance. Sarwer says surgeons need to improve screening of at-risk women.

The warning comes as surgeons are reporting a surge in requests for newer silicone gel-filled implants that contain thicker and firmer gels than the more fluid silicone implants of 20 years ago and that can avoid the "wrinkling and crinkling" that can occur with saline implants [a silicone bag filled with salt water].

The demand for silicone breast implants "is a totally patient-driven phenomenon right now," De Lorenzi says.

An estimated 100,000 to 200,000 women in Canada have breast implants, about 80 per cent for cosmetic augmentation.

Cosmetic breast surgery may be more popular than ever, but it is nothing new. In Making the Body Beautiful: A Cultural History of Aesthetic Surgery, author Sander L. Gilman reports the first modern breast augmentation occurred more than 100 years ago, when a Heidelberg surgeon operated on a 41-year-old singer who had a growth in her breast removed. Fat was cut from a growth on the woman's back to build a new breast.

But breast augmentation did not begin in earnest until the 1950s, when, Gilman writes, people began to "search for cures for this new disease of too-small breasts.'" Where once large breasts were "signs of the primitive," today "many more women are persuaded that their breasts are too small than are persuaded that their breasts are too large."

The first generation silicone implants in the 1960s had thick shells; some had a Dacron patch on the back that was stitched to the woman's chest wall.

"Initially it was thought that if you put these things under the skin they're going to slide all the way down to the groin or the tummy and it's going to look ridiculous, so you have to fix it to the chest wall somehow," De Lorenzi says.

Those concerns were quickly replaced with worries over the risk of capsular contracture. The body reacts to any kind of implanted material, whether a heart valve or hip joint, by trying to wall it off from the rest of the body with collagen. With breast implants, collagen forms loosely around the devices and contracts with time, forming scar tissue. Some women are not bothered, or suffer only mild discomfort, but others complain of severe pain.

Manufacturers responded by adding more silicone oil to the gels to make them softer, in order to trick the body. While the new implants were softer, they were also "runnier." If the implants ruptured, surgeons not only had to remove the cocoon of scar tissue around the implant, but the gel that had oozed out. "Sometimes [the implant] would break, and you would have this gooey stuff all over the place," De Lorenzi says. "And it was difficult to remove 100 per cent of it."

Anecdotal and case reports began surfacing linking ruptured implants and migrating silicone gel with autoimmune problems such as rheumatoid arthritis, lupus and scleroderma. In January 1992, the FDA ordered U.S. doctors to stop using silicone gel implants until their safety could be proven. Manufacturers pulled their implants off the Canadian market the same year, though the devices became available again in 1999 under Health Canada's "special access" program. They are available on a case by case basis for women who who would not do well with saline implants.

Several large studies, including a major 1999 report by a panel convened by the U. S. Institute of Medicine, found no evidence silicone breast implants cause systemic complications such as autoimmune diseases. The recent study involving Finnish women found cancer deaths among women with breast implants were "close to expectation."

But, Aleina Tweed, author of the Canadian study that found women with breast implants use the health system more, argues many studies have followed women for too little time to completely rule out concerns about long-term safety.

She also says the studies focused on known diseases, "instead of a possibly new, undefined illness."

Even the risks of local complications are not insignificant, she says. For example, about one in four women who undergo breast implant surgery will experience capsular contracture, usually within two years of surgery, according to Health Canada.

De Lorenzi says the risk is far lower with the newer, denser silicone gel implants. Of 170 patients he has operated on so far using the newer implants, not one has experienced capsular contracture.

But all implants have a fixed lifetime and will eventually need to be replaced. "If you put breast implants in, are you going to need more surgery in your life? The answer is 100 per cent yes," says De Lorenzi. "But it's not because you're going to get arthritis or any of those other things, it's because your implants are going to fail at some point. It's not a one-time deal."

He wants to see a national breast implant registry, to track complications and provide better follow-up of women.

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