"This operation makes happy ladies," Dr. Biggs says. "It's an operation that beautifully fits the average American woman."
Texas women seem particularly charmed by its cosmetic benefits. Not only does this state rank high in the number of cosmetic surgeries performed (along with Florida and California), but its women request larger breasts more frequently than their East Coast counterparts. "For a region to be a cosmetic capital, it has to have money, because it's an elective surgery and you are paying out of pocket," explains California psychologist Barbara Nash, author of What Your Doctor Didn't Tell You About Plastic Surgery. "The culture probably has to have a large investment in image and body appearance, and a warm climate where you can show off that appearance."
It also helps that Dallas has a deep pool of talented plastic surgeons who are adept at performing what amounts to a fairly simple procedure. After the patient receives a general anesthetic, the surgeon makes an incision in one of three places: in the fold of the breast, in the armpit, around the areola. To position the implant, he creates a pocket, either over the muscle separating the breast tissue from the ribs or partially behind the muscle. Either way, the surgeon centers the implant behind the nipple and then inflates the implant with saline. Silicone-gel implants are prefilled.
"You make a space, make certain there is no bleeding, insert the implant and close it up," says Dallas plastic surgeon Edward Melmed. "It's not rocket science."
But it's not without its complications. The most common is known as capsular contracture--the capsule of scar tissue that forms around the implant as the body's natural defense to the foreign object invading it. In serious cases, the scarring hardens and rounds the breast, creating a grapefruit-in-the-sock effect--the fake-looking, never-at-rest Baywatch boob. The scarring can also hurt like hell, lead to shell rupture, gel leakage and more operations. But some plastic surgeons have suggested that it shouldn't even be labeled a complication, minimizing its sting by calling it a side effect, an expected result, a consequence. Other possible consequences of augmentation include rupture from trauma to the body, infection, disfigurement, hemorrhaging and reduction in nipple sensation.
For nearly 30 years, marketing leaped ahead of science, and many plastic surgeons undersold or misunderstood these risks. Not until the late '80s did research indicate that silicone might not be the safe substance it had been promoted to be. Thousands of silicone-implanted women and their lawyers complained about autoimmune, neurological and muscular-skeletal disorders. Ralph Nader's public advocacy group warned that silicone implants might cause cancer. By 1990, Congress heard these complaints and decided to investigate.
The congressional oversight committee that had jurisdiction over the FDA, which had neither regulated nor approved silicone gel implants, learned that implant manufacturers had never tested their products on humans. "It was only assumed implants were safe because the manufacturers had said they were safe," says Dr. Diana Zuckerman, who worked on the committee and now heads the National Center for Policy Research for Women & Families. "We were given internal memos from Dow Corning that showed their own scientists believed implants leaked and had concerns about their safety."
Mounting public pressure was forcing the FDA to take some sort of regulatory action, though the agency seemed conflicted about what course to take. Weighing the risks vs. benefits of plastic surgery was no easy matter, particularly after plastic surgeons encouraged their patients, many of them who had undergone breast reconstruction following mastectomies, to lobby the FDA on their behalf. Doctors also enlisted a public relations firm to design a campaign couched in the language of the pro-choice movement, Zuckerman says. "Women were told they had a right to choose for themselves. But how could they make a choice when there were no studies to inform them?"
Dow Corning contended that any link between its implants and disease was purely coincidental. It held fast to this position throughout its bankruptcy reorganization, which was largely brought on by the 177,000 women who claimed otherwise. Ironically, the company would be vindicated by a 1999 Institute of Medicine study, which reviewed all the research that had come before it and found no causal connection between implants and major disease.
In April 1992, however, the FDA finally placed the burden of safety where it belonged: on implant manufacturers. Because they couldn't meet that burden, the agency banned silicone gel implants for first-time augmentation patients. Women who were undergoing reoperations or breast reconstruction could use silicone gel if the surgery was part of a government-approved clinical trial. Despite their silicone outer shell, saline-filled implants were not restricted, partly because it was believed that any damage caused by salt water migrating upon rupture would be insignificant.