FDA Bows to Industry: OKs Risky Kind of Breast Implant
By Jan Erickson, Government Relations Director
In a clearly industry-influenced decision, the Food and Drug Administration (FDA) issued final approval on November 17 to two implant makers, Allergan Inc. (formerly Inamed) and Mentor Corporation, to market their risky silicone gel-filled breast implants to women age 22 and older.
In doing so, the FDA ignored disclosures by three company whistleblowers that Mentor had falsified data, failed to disclose damaging information about leaky valves and rupture rates and — most alarmingly — failed to report accurate information about levels of a form of oxidized platinum in the implants that is known to be harmful to humans. In all three cases, the FDA did not require new studies to evaluate the allegations.
Reportedly, more than a million dollars was spent by the manufacturers and plastic surgery groups to put pressure on Bush appointees at the FDA to approve these implants.
NOW President Kim Gandy called the FDA decision "irresponsible" in light of considerable evidence that the silicone gel implants are not safe and in response to the FDA's refusal to conduct additional safety studies and not require full disclosure from the companies of all relevant data.
"It should be obvious by now," added Gandy, "that Bush-appointed FDA officials have little concern for the health and safety of the public and that an attitude of 'buyer beware' prevails. Women and their children will pay the price for such reckless policies."
Rep. Rosa DeLauro (D-Conn.) found the FDA decision "disturbing," while Sen. Dianne Feinstein (D-Calif.) expressed concern over the move. Dr. Susan Wood, former head of the FDA's women's health office, stated that the long-term safety of silicone breast implants remains largely unproven. Dr. Sidney Wolfe of Public Citizen pointed to "high rates of rupture, the need for repeat surgery and clear evidence of lymph node infiltration and damage by leaked silicone" and said that "silicone gel breast implants are the most defective medical device ever approved by the FDA."
Just prior to the decision, FDA researchers published an article in the Journal of Long-Term Effects of Medical Implants that details reports to the agency since 2002 of illnesses, diseases and deformities in women with implants and in children born to them after the procedure. They noted over 300 "adverse events," including difficulties with breast-feeding, muscle weakness, urinary tract infection, skeletal abnormalities, cardiac problems, brain malformations, esophageal/feeding problems, central nervous system disorders, blindness, connective tissue diseases/symptoms, pulmonary/respiratory difficulties, allergies, learning disabilities including anxiety, depression, manic-depressive disorder, emotional changes, psychosis and many other serious health problems.
In October, the third whistleblower, a senior scientist formerly with Mentor, reported that company studies "showed that in the silicone rubber envelope of the implant, platinum existed" in a toxic form." This information had not been provided to the FDA by Mentor.
This scientist also charged that other company data, which suggested a continual leakage of dangerous low molecular weight siloxanes (a compound of platinum and oxygen) from the implants into women's bodies, also was not submitted to the FDA, and that other test data was invalid and fraudulently represented.
Earlier this year, a peer-reviewed article in Analytical Chemistry reported high levels of toxic platinum salts in the hair, nails, blood and breast milk of women with implants and in their children. The FDA placed on its website a dismissive response prepared by a paid consultant to an implant maker.
Several citizen petitions were submitted to the FDA asking for a delay in the final decision and requesting studies on possible links between the toxic platinum and the illness and diseases reported by women and conditions found in their children. The petitions were rejected.
In granting marketing approval, the FDA stipulated that the companies study 40,000 women who get silicone gel-filled implants over ten years, in addition to monitoring 10,000 women who already have the implants. The agency cautioned that implants last only about ten years and that women will need frequent magnetic resonance imaging (MRI) exams to determine any rupture or leakage. In other words, millions more women will become experimental subjects, risking illness and injury. Any children that they may have will be at risk of deformities and serious health conditions.
It should be noted that to date, these two companies have done a very poor job of monitoring women who get silicone implants (usually for reconstruction or revision purposes) — as they were required to do — over the past 14 years. NOW and women's health organizations have heard from women who became ill with silicone breast implants and were dropped from the monitoring effort. No doubt, this had the effect of hiding and minimizing the health risks of silicone implants.
In the U.S., about 300,000 women each year get implants, costing from $6,000 to $10,000. Eighty percent are for cosmetic reasons. Removal of implants costs more than the original implantation; neither procedure is covered by insurance if done for cosmetic reasons. The recommended MRI exams to check for silicone leakage (usually costing between $1,500 and $2,000) would have to be paid out-of-pocket, as well.
Industry income from breast implants is estimated to rise from the current $400 million annually, (excluding surgeons' fees) to perhaps twice as much with new demand, and continuing to increase. Cosmetic patients' lifetime expenditures for expected repeat implant surgeries and exams could be a hundred thousand dollars or more — not including the cost of treating injuries or illness in either the woman or her children.
NOW is determined to continue working on this issue, educating women about the risks and the true cost of these implants, and working with allies in government to achieve the oversight that has been sadly lacking.
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