Silicone Cleavage Bounces Back
By Kristen PhilipkoskiWomen in the United States may soon have open access once again to silicone breast implants, which were taken off the market in 1992 because of safety concerns.
Canadian regulators cleared the implants for sale and implantation in October. Silicone implant makers -- as well as many women who believe silicone implants look and feel more natural than alternatives such as saline bags -- expect the Food and Drug Administration will soon follow in Canada's footsteps.
"FDA is currently reviewing applications submitted by Inamed and Mentor for cohesive silicone gel breast implants," wrote Heidi Valetkevitch, a press officer at the FDA, in an e-mail. "Canada's decision to approve standard silicone gel breast implants manufactured by Inamed and Mentor is consistent with FDA's determination in 2005 that these devices are 'approvable,' pending resolution of certain issues."
Valetkevitch declined to elaborate on the pending issues.
In September 2005, the FDA issued a letter deeming "approvable" silicone implants sold by Allergan (which owns Inamed) and Mentor, and the companies have been waiting ever since for final clearance.
Over the past 14 years, only women who agreed to participate in a clinical trial, and all the monitoring and follow-up that requires, were eligible to receive silicone implants.
Many women (and men) believe that silicone implants feel more natural. At the Plastic Surgery conference in September in San Francisco, implant makers displayed their wares in the conference's exhibition hall. To this reporter, the saline implant felt like a water balloon. The silicone implants displayed in the exhibit hall felt like a gel -- a bit denser than hair gel.
To show the artificial breast's ability to remain intact when damaged, one implant was sliced open. The gel did not run out. It was sticky to touch but stayed in place.
"Because we've not been able to use silicone for the past 12 to 13 years, we've gotten pretty darn good with trying to mask that water-bag feel," said Dr. Roxanne Guy, president of the American Society of Plastic Surgeons. Instead of putting saline implants directly under the skin, surgeons wedge it between muscle to give a more natural look and feel.
One implant recipient who asked to remain anonymous underwent this procedure in 1999 using Mentor's saline implants, and she is happy with the results. But she's also been closely following advancements in silicone implants.
"I would be interested in the new cohesive silicone implants," she said. "I have read that these are the best and most real-feeling. They will not 'bleed' if they rupture. The consistency is like a gummi bear."
Concern arose in the late '70s and early '80s about leaking silicone implants. Some women believed that leaking gel led to problems such as immune diseases that cause the body to attack its own cells. The FDA asked companies for safety data, but it didn't exist.
"It's like telling Nokia or Motorola they haven't proved cell phones don't cause brain cancer," said Pat Maxwell, a Nashville, Tennessee-based plastic surgeon and a clinical professor of surgery at Vanderbilt University. Maxwell helped invent the silicone breast implant marketed by Inamed, which was bought by Allergan for $3.21 billion in March.
Silicone implant makers were forced to take their products off the U.S. market except for treating mastectomy patients and some other special cases. The link with immune disease and other problems was never proven.
"Scientists performed studies to try to satisfy questions about systemic disease which I think have been answered quite well," Guy said.
In 1999, the Institute of Medicine published a report that found silicone breast implants don't cause cancer or rheumatoid arthritis. One study in 2001 found an increased risk of fibromyalgia was associated with silicone breast implants, but further studies failed to confirm the finding.
Maxwell noted that penis implants that have been used for decades are made of the same type of silicone as their breast counterparts.
In 2005, 340,000 American women had breast-implant surgery, according to the American Society for Aesthetic Plastic Surgery. Most of them -- 85 percent -- received saline implants.
In other parts of the world like Europe and South America, silicone implants are used in the vast majority of procedures, and silicone is widely considered to be safe.
"American surgeons are 15 years behind the times. In Tasmania, of all places, they're shocked that American women don't have access to silicone gel implants," said Maxwell, who was on the Australian island to speak at a plastic surgery conference.
But some consumer interest groups are not convinced. Public Citizen, a nonprofit watchdog group focusing on health and safety, released a petition Thursday urging the FDA not to approve silicone implants. Women's organizations including the National Organization for Women are against approval, and several websites, including the Humantics Foundation and Silicone Holocaust, attest to the dangers of silicone implants.
Ilena Rose, who runs the Humantics Foundation, said she believes surgeons who deny that silicone breast implants cause health problems are simply motivated by money.
"If a plastic surgeon inserts just two pairs of implants a week ... that's over a half a million dollars annually coming in to their coffers in implant revenue alone," Rose said on a web page she created to respond to questions from Wired News.
The FDA says both silicone and saline implants carry risks including asymmetry, pain, hematoma, inflammation, scarring, rippling and more.
Wayne Perron, a Calgary, Alberta-based plastic surgeon, uses Mentor's cohesive gel silicone implants.
"There's no question this is a beautiful implant," Perron said. "The engineering is superb and the long-term follow-up shows extreme safety."
He prefers them to saline, he said, because saline leaks and deflates more often. He said women with saline implants are also more likely to encounter rippling and capsular contracture, which is caused by collagen fibers that tighten and squeeze the implant, distorting its appearance.
Perron emphasized that all implants, breast or otherwise, carry risks. "These are mechanical devices. They're like tires on your car and at some point they may have to be replaced. They are not lifelong implants."
