A Columbia woman is set to testify today in Washington, D.C., before a Food and Drug Administration advisory panel that will determine whether silicone breast implants are safe enough for widespread use after 13 years of strict regulations.
Kathy Keithley-Johnston is the founder of Toxic Discovery, a national consumer advocacy group based in Columbia. Her testimony will be one of many from women who have had breast implants.
The committee of plastic surgeons and other experts will meet today through Wednesday to decide whether to recommend lifting the restrictions on silicone breast implants the FDA imposed in 1992. The regulations made the silicone implants available only to women who participate in heavily regulated research studies.
Introduced in 1962, silicone breast implants came under scrutiny in the late 1980s and early 1990s after thousands of women said ruptured implants caused numerous health difficulties. Health experts estimate that 93 percent of silicone breast implants rupture within 10 years.
The frequency of breast augmentations has risen by 147 percent in the past five years and is the most commonly performed cosmetic surgery procedure.
The committee is expected to issue a recommendation to the FDA as to whether the implants are safe for widespread use.
Keithley-Johnston gave evidence to the same committee in 2003. The FDA ruled there was not enough evidence about the safety of the implants and the effects of silicone on the body to allow widespread use.
Keithley-Johnston founded her group in 1994, after her silicone breast implants ruptured and were removed. As a registered nurse, Keithley-Johnston knew she was not the only one affected by silicone breast implants and the lack of information about their effects.
“I felt that as a medical professional, that if I could not find information, a nonmedical professional certainly would not be able to,” she said.
The group spearheads advocacy efforts for people injured by other medical devices, not just breast implants, and has more than 25,000 members.
Keithley-Johnston’s main goal is to make sure the advisory committee makes a decision based on science and hard evidence, not politics and industry ties to breast implant manufacturers. She, and other women like her, are asking the FDA to create a national registry to keep track of illnesses, complications and deaths related to breast implants.
“As consumers and women, we should demand to know what’s going into our bodies,” Keithley-Johnston said. “We’re just not demanding superior goods. We do on everything else, but not medical devices.”
Keithley-Johnston and others making the trip to Washington will also read written testimony from other people affected by breast implants.
“We feel we’re taking the heart and spirit of all injured consumers with us,” Keithley-Johnston said.
One of those people is Cindy Fuchs-Morrissey’s 14-year-old daughter, Hilary. Hilary’s testimony about the impact of silicone breast implants will be read to the panel in Washington.
Fuchs-Morrissey is blunt about the effect of silicone breast implants on her daughter.
“She was born a silicone birth, and she’ll probably die a silicone death,” said Fuchs-Morrissey, a Columbia native and the co-chairperson of Toxic 2 Kids, part of Toxic Discovery.
Hilary has scleroderma, a disease that causes skin and organs to harden. Hilary’s disease makes it difficult for her to swallow. In addition, she has an insulin resistance problem and a number of neurological and bone conditions. Her hands and feet are the size of an infant’s — she wears a size eight infant-toddler shoe.
There is not a large body of research to definitively connect silicone breast implants and scleroderma, but some research suggests there is a relationship between the two. Hilary and her mother are convinced that Hilary’s illness is a direct result of the silicone in Fuchs-Morrissey’s body.
Fuchs-Morrissey received silicone breast implants for her 18th birthday to correct a congenital chest deformity. Her chest was extremely asymmetrical, and she was seeking options to even it out. The plastic surgeon suggested breast implants as a solution, but Fuchs-Morrissey said she thinks the surgeon’s motivation was money, not her well-being.
“I went to the plastic surgeon because I thought he had the wisdom to guide me, but only found out he was like a pimp wanting to make money from his sale,” she said.
She received the implants in 1976. Two years later, she had the implants replaced because of complications. She did not find out the original implants had actually ruptured until she requested her medical records in 1992.
In 1993, Fuchs-Morrissey had a full mastectomy.
“I may be one of the few women who are happy with the results of a mastectomy,” she said, noting that after years of complications, the mastectomy finally gave her the result she sought in 1976.
Hilary’s prognosis is uncertain, but Fuchs-Morrissey is certain her family’s experiences will help teach medical professionals and breast implant manufacturers about the potential dangers of silicone breast implants.
“Hilary was placed here on earth to show those that play God with medicine that they do hurt people,” she said.