By Jim Schutze
By Rachel Watts
By Lauren Drewes Daniels
By Anna Merlan
By Lee Escobedo
By Eric Nicholson
"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 Baywatchboob. 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.
After one FDA hearing, Dr. John Tebbetts, a Dallas plastic surgeon, grabbed the national media spotlight, briefly appearing on ABC's World News Tonight.While contending the FDA should not ban silicone implants because their saline substitutes do not look as natural, he added, "You have committed patients to a breast that is far from normal, compared to a gel-filled implant."
What he didn't say was that he had already begun his quest for an implant that would present a more natural-looking breast: the anatomic.
In Tebbetts' Oak Lawn medical offices, subtle suggestions are at work: the mauve and lavender walls that soothe the anxious and ease the uncertain; the sculptures and paintings of swans that hint at a transformation from ugly duckling; copies of The Best Breast, which intimate that its author is the best person to deliver the best breast.
And then enters Tebbetts, who instantly diffuses this air of subtlety with his blustery, East Texas country-boy demeanor. At 55, he's a likable cuss, a no-nonsense, tough-talking, opinionated man who tends to dominate the conversation. His hunger to be challenged is evident from the array of photos in his inner office that show him dirt-biking and tarpon-fishing. He inspires strong feelings from his colleagues, who describe him with a mix of guarded admiration and disdain. They find him a bright, innovative surgeon who aggressively promotes his own innovations: "He is as skillful on the breast as anyone in the world." "He's the Jesse Ventura of plastic surgery." "John is widely regarded as being very enthusiastic about his own ideas."
And Tebbetts is full of big ideas. In addition to designing new implants, he has developed new surgical tools and breast-augmentation procedures that minimize tissue damage and hasten recovery. Ninety-five percent of his implant patients, he says, are back to normal activity within 24 hours. He is largely credited as the first plastic surgeon to publicly condemn the fashion of bigger-is-better by advising patients and colleagues that the too-large breast will ultimately sag, whether augmented or not. He is a strong advocate for patient education, insisting his patients read his book before they consult with him. His résumé lists more than 150 scientific publications and presentations that have published his work, though he is criticized for being overly verbose and unnecessarily complex in his writings.