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Raising Health Awareness Through Examining Benign Brain Tumor Cancer, Alpha One and Breast Implant Issues.
Subcommittee on Health
Miss. Kim Hoffman
Mr.
Chairman and Members of this Committee: thank you for giving me the opportunity
to testify. My name is Kim Hoffman. I am a breast implant recipient from
Missouri. As
the watchdog of public safety for food, drugs and medical devices, the FDA has
failed specifically in its duties, by allowing a medical device with high
complication rates to be marketed to American women by companies with dubious
manufacturing practices. Like
Pam, who is here today, and thousands of other women, I experienced numerous
debilitating problems immediately after receiving my textured, silicone breast
implants, manufactured by Mentor Corporation, in 1995.
To receive silicone implants after the moratorium in 1992, I was required
to participate in a clinical study.
Because data collected in this study could effect FDA's decision as to
whether the agency should approve the wide spread availability of the product, I
recognized the importance of accurately documenting my problems and including
them in the study. I
reported my problems to my surgeon.
He ignored me.
I obtained a copy of the study protocol and realized a number of study
rules had been violated.
I reported the violations, and
my physical problems to the manufacturer, who was the sponsor of the study and
to the FDA; again, I was ignored.
After
numerous attempts to report my complications as a study participant, I received
a form from my file at the manufacturer; it read, "patient has no
complaint." Astonished
by the apathetic responses I'd received, and being from the show me state, I
began my own investigation.
I interviewed several other study participants and found problems with
their cases as well.
I was able to talk to people who worked for the manufacturers and even a
couple of industry whistle-blowers.
From them I learned that not only were there problems with the study and
the documentation of problems experienced by patients, but the companies were
having major problems with quality control issues and were violating good
manufacturing practices.
These problems had gone on for years. These
individuals alleged that there were problems with the implant design and gel
suppliers; there were defects with the implants, valves, and outer shell; and
there were inconsistencies in the gel used to fill implants.
It appeared many of these problems had been concealed from the FDA.
I reported this information to the FDA, several
people at the FDA, but there was no apparent action. Disturbed
by the lack of responsiveness at the FDA, in the summer of 1998 I put all of the
information together, information about the clinical trials and the
manufacturing problems alleged by industry employees, and gave it to Congressman
Green, the FDA,
the House Energy and Commerce Committee, and eventually to Congressman
Blunt. The
FDA's copy was given to James Austin Templer, a FDA compliance officer who
oversaw Mentor Corporation, the manufacturer I had gathered the most data about.
Mr. Templer referred the information to the FDA's Office of Criminal
Investigations, and in 1998 a criminal investigation was opened.
Throughout
1999, I continued to receive alarming information, which was given to Mr.
Templer and then forwarded to the FDA's criminal investigators.
Unfortunately, little was done, in spite of the shocking information that
was uncovered and
Mr. Templer's efforts to push the investigation forward.
It became obvious to both of us that there were significant problems with
the medical devices and the integrity of the manufacturing process.
Furthermore, it appeared internal problems at the FDA were undermining
consumer protection. The
situation became critical in 2000.
The FDA had announced that saline breast implants would be considered for
market approval in the spring, and Mentor Corporation would be submitting a
pre-market application (PMA) for approval of their products.
The criminal investigation had gone nowhere and regulatory actions had
been put on hold because of the criminal investigation.
In January 2000, in frustration and out of a concern for American
consumers, Mr. Templer tendered his resignation from a twelve-year
career at the FDA.
He hoped his resignation would get the attention of the agency. In his
resignation letter to the commissioner, he, among other things, urged the agency
to conduct a thorough investigation of the allegations, which had been made
about the manufacturer and the study, prior
to the agency's approval of saline breast implants.
Unfortunately, the FDA again chose to look the other way. In
May 2000, the FDA approved saline breast implants.
The approval came in spite of Mr. Templer's recommendation, in spite of
complications rates as high as 43% for cosmetic patients and complication rates
of over 70% for reconstruction patients (in the first 3 years), and in spite of
an ongoing open criminal investigation into one of the manufacturers, which
remains open even today.
Sadly,
consumers believe "FDA approval" of a product means that the product
has been adequately studied and has been found to be safe and effective for it's
intended use. I'm not sure this should be concluded with this device.
Unfortunately, the average consumer who might purchase this product will
not have access to the information the FDA has ignored during the approval
process, resulting in an inappropriate assumption of safety and effectiveness. It
is my fear that by ignoring the regulatory problems, the criminal allegations,
the high complication rates and the recommendation of the FDA's own staff, the
agency has lowered
the bar for what is considered a safe and effective medical device.
Additionally, the ramifications of the FDA's decision could be widespread
and ultimately effect other products and many American consumers. It
was this concept which disturbed Mr. Templer and me so deeply.
Mr. Templer couldn't be here today, however, he asked me to advise the
committee of his
professional opinion regarding this topic. Mr.
Templer writes, "Based upon information I was aware of as an FDA official
it does not surprise me that breast implant recipients are experiencing
significant health consequences.
I was aware of many quality control issues as well as situations where
FDA employees illegally assisted an implant manufacturer.
I reported these issues, but the FDA wanted to sweep the matter under the
rug. In
my opinion, the FDA has not adequately monitored or investigated the safety of
breast implants, and in fact, they have looked the other way when credible
allegations of criminal conduct have been made.
I urge the committee to take the actions necessary to protect the public
health, because the FDA has clearly failed to do so." I
agree with Mr. Templer: it will take an act of Congress to get to the bottom of
the breast implant debacle.
However, Congress must insist that our country's watchdogs are doing
their jobs. The
passing of this bill is a great first step.
H.R. 1961 will ensure the FDA has full oversight and will provide
accountability.
The passing of this bill will ultimately benefit women's health and could
also impact FDA's oversight of all medical devices.
I
want to thank Congressman Gene Green for his steadfast leadership on this issue,
and I would also like to thank my Congressman, Roy Blunt, for his support.
I would also like to thank members of this panel who have co-sponsored
H.R. 1961. We
are grateful for the support of Representatives Sherrod Brown, Ed Bryant,
Richard Burr, Frank Pallone Ted Strickland and Heather Wilson.
Thank
you for your time today and I urge you to make it a goal to pass this bill in this
Congress. Breast
implants have been put in women's bodies for over 30 years; it's high time we
understand the long-term effects of this product and insist that they be
manufactured with integrity and in accordance with good manufacturing practices.
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