Monday, April 11, 2005 3:48 p.m. ET
By Susan Heavey
GAITHERSBURG, Md. (Reuters) - Numerous women said silicone breast implants restored their confidence after cancer surgery, but others told experts weighing whether to allow the devices to be sold widely again that leaking silicone and other complications made them sick.
The three-day meeting by Food and Drug Administration advisers began with emotional testimony from patients, doctors and interest groups both supporting and opposing implants made by Inamed Corp. and rival Mentor Corp.
The devices have been banned for most U.S. women since 1992 due to health concerns, but are available in other countries. Studies have failed to find links to lupus, arthritis or other chronic diseases.
Several women and plastic surgeons said the silicone gel- filled devices have a more natural look and feel than saline- filled breast implants.
"I will know every day for the rest of my life that I don't have real breasts, but this is as close as you can get," said Terry Heide, a breast cancer survivor from Virginia.
For her, the risks with silicone are worth taking to have a more normal-looking body. "Yes, implants fail and planes crash and people get cancer," she told the panel.
Both Mentor and Inamed, which is being bought by Medicis Pharmaceutical Corp., have said new silicone implants are sturdier and the gel is stickier and less likely to migrate.
Nevertheless many patients are convinced leaking silicone and the platinum catalyst used to turn it into a gel -- has made them sick.
Those patients and some family members warned of suicide risk, extreme fatigue and silicone oozing from their scars.
"I don't want anyone else to suffer this way," Susan Helman of Florida said, adding she suffered from headaches and nausea after her implants leaked.
In October 2003, an FDA advisory panel said Inamed's silicone implants were safe enough to be sold, but the agency rejected the application and asked all makers to collect more data on when and how often the devices break.
Testimony from patients and doctors was due to go until late Monday evening. The panel of experts will review Inamed's new data on Tuesday and Mentor's studies on Wednesday, but the FDA will have the final say.
"This meeting is not intended as a general referendum on silicone breast implants," cautioned Miriam Provost, acting director for the FDA's device evaluation division. "We will make our decision based on the scientific data."
Since the 1992 ban, only breast cancer survivors and others needing reconstruction or implant replacements have received silicone implants through clinical trials.
Opponents were also concerned about the effects on breast- feeding mothers or younger women, who they worry are influenced by televised make-overs and may be targeted by manufacturers.
A dozen young women, wearing T-shirts emblazoned with "100 percent natural" across their chests, testified that most teen- aged women do not grasp that implants can make it difficult to detect breast cancer or obtain health insurance.
Last week, FDA staff reviewers questioned both companies' data, which they said failed to shed light on how likely the devices were to break and cited estimates that anywhere from 21 percent to 74 percent could break after 10 years.
According to the American Society of Plastic Surgeons, more than 264,000 cosmetic implant procedures and nearly 63,000 breast reconstructions were performed in 2004.
