| Ilena Rose 2006-09-29, 9:28 pm |
| http://www.now.org/press/09-06/09-21.html
NOW Applauds DeLauro Legislation Holding FDA Accountable on Emergency
Contraception, Breast Implants
September 21, 2006
"It's obvious that the Food and Drug Administration is no longer the
watchdog for public health and safety," National Organization for
Women President Kim Gandy said today, welcoming legislation proposing
corrective measures for recent ill-advised FDA actions on Emergency
Contraception (EC) and risky silicone gel breast implants.
Today Rep. Rosa DeLauro (D-Conn.) is introducing the FDA Scientific
Fairness Act for Women, and Gandy praised the provision to establish a
scientific process within six months to review the safety of EC (also
known as Plan B) for use by women under 18 without a prescription.
"The FDA's inexcusable delay in approving this safe drug, and then
denying it to young women—despite recommendations for approval by two
FDA advisory panels and major medical associations—reveals the
agency's failure to uphold its mandate to make scientifically sound
decisions," Gandy added.
The DeLauro bill would also halt the FDA approval process on silicone
breast implants until the FDA establishes the life of silicone breast
implants and implant makers can demonstrate adequate safety of their
products for the established lifetime of the product. This would help
women by reducing their exposure to rupture and leakage.
Another important provision calls for an independent scientific study
of the effect on women and their children of toxic platinum salts from
silicone gel breast implants. A recently published article in the
peer-reviewed journal Analytical Chemistry reported high and hazardous
levels of an oxidized form of platinum in hair, urine, blood and
breast milk samples.
Gandy said, "More research is critically needed to determine what role
these toxic platinum salts may play in making some women and their
children very sick." The presence of the toxic ingredient in implants
was first reported at the 2003 NOW Foundation scientific symposium
examining silicone gel breast implant safety questions.
The FDA has been dismissive of these alarming findings and appears
ready to approve two applications to market silicone breast implants
to the general public. In fact, the FDA has already issued preliminary
"approvable" letters to Inamed and Mentor corporations, the two
implant makers who want to sell these dangerous types of implants.
These manufacturers have spent hundreds of thousands of dollars to
promote their implants and to put heavy pressure on FDA officials to
approve their applications.
Silicone gel implants were withdrawn in 1992 when thousands of women
reported serious illnesses and injuries after receiving the implants.
Later, thousands of lawsuits were filed against a number of
manufacturers by women made ill by the implants, and by the U.S.
government on behalf of many hundreds of women covered under federal
health care programs.
Dr. Susan Wood, former Assistant Commissioner for Women's Health and
Director of the FDA Office for Women's Health, who was honored at
NOW's National Conference as a Woman of Courage, summed up the problem
in her conference remarks: "What we have apparently is a small group
of people with enormous influence who can overrule good science, who
can overrule good health policy, who can overrule an interest in the
public health of individuals around the nation."
~~~~~~~~~~~~~~
www.BreastImplantAwareness.org
Links to contact your Congress Member to support this imporant act
|