Fw: House Hearing on: Raising Health Awareness Through Examining Benign Brain Tumor Cancer, Alpha One and Breast Implant Issues

[Guest guest]

----- Original Message -----

From: " ilena rose " <ilena@...>

Sent: Friday, November 16, 2001 4:23 PM

Subject: House Hearing on: Raising Health Awareness Through Examining Benign

Brain Tumor Cancer, Alpha One and Breast Implant Issues

>

> Following message will give the history of the Consent Decree Ordered

> Against Mentor in 1998.)

>

> (If you go here, with Real Audio, you can hear the entire testimony.)

>

>

http://energycommerce.house.gov/107/hearings/11152001Hearing428/hearing.htm

> (worth looking at ... photo etc.)

>

> Here is Kim Hoffman's Speech ~ Bravo to Kim and all the other fine

speakers!

>

> 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 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 , Burr, Pallone Ted Strickland and

> .

>

> 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.

>

>

>

>