By SARA AGNEW of the Tribune’s staff

Published Saturday, April 9, 2005

Kathy Keithley-Johnston says there is no such thing as a safe silicone-gel breast implant.

Keithley-Johnston

"Almost every breast implant will fail in the body over time," said Keithley-Johnston, a Columbia registered nurse and executive director of Toxic Discovery. "And no one knows the long-term effects of silicone on the human body." That’s why she is flying to Washington, D.C., tomorrow to testify Monday in front of a U.S. Food and Drug Administration panel about the dangers of silicone breast implants.

Keithley-Johnston, whose Columbia-based breast-implant consumer group represents 25,000 women nationwide, wants to urge FDA officials not to lift a moratorium on a wider use of silicone implants. Another nurse, Jana Kueck of Branson, and implant patient Cindy Morrissey of Macon plan to join Keithley-Johnston on the trip and testify before the panel.

"Women do suffer painful and debilitating complications directly related to breast implants," Keithley-Johnston said.

Since 1992, silicone-gel breast implants have been available only to women who have had mastectomies or to those involved in controlled research studies because of fears the implants could cause major health problems. The government is considering lifting that ban, but federal scientists still have concerns about breakage and the

long-term health risks of silicone leaking into the body.

A public hearing is set to begin Monday before the FDA’s General and Plastic Surgery Devices Panel. According to an FDA Web site, the panel is expected to make a recommendation Wednesday.

"I don’t believe they can do a safe breast implant yet," Keithley-Johnston said.

Inamed Corp. and Mentor Corp - the only U.S. companies that manufacture breast implants - believe their products meet federal requirements and argue that, as with pacemakers and metal hip joints, they don’t last forever but have improved over time.

Keithley-Johnson received silicone-gel breast implants in 1984. Only three months after the surgery, she said, she began experiencing chest pain, headaches and fevers. By the time she had the implants removed in 1994, after one ruptured, she had lesions all over her body, bladder difficulties and other disorders. Eventually, she was able to secure Social Security disability benefits.

"I am 95 percent recovered," she said. "But I still have some problems. I have not had implants put back in."

Over the years, researchers have mostly found that silicone implants do not cause serious illnesses such as cancer and lupus. But concerns remain about scar tissue that can form around the implant and breakage of the implants, requiring surgery for removal or replacement.

An FDA panel has found that 93 percent of silicone-gel implants rupture in 10 years. So do saline implants, but researchers say women quickly recognize such breaks because their breasts deflate and there is little risk associated with saline seepage.

According to the American Society for Aesthetic Plastic Surgery, nearly 335,000 women had breast augmentation in 2004, the vast majority with saline implants. More than 62,000 women had breast reconstruction last year.

"Breast implants, as with any other medical device, do not last a lifetime," said James Wells, past president of the American Society of Plastic Surgeons. "No medical device is flawless, and neither are silicone implants or saline, for that matter. … If the science supports the safety and effectiveness of these devices, women deserve to have silicone implants as a choice."