Re: FDA Saline BI Testimony

[Guest guest]

Excellent post dear thanks!

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

From: MARTHA-NSIF

BreastImplantNews

Cc:

Sent: Wednesday, February 27, 2002 3:20 AM

Subject: FDA Saline BI Testimony

INFORMED CONSENT & BREAST IMPLANTS

FDA Saline Testimony I — 03/01/99

My name is Martha Murdock, Founder of the National Silicone/Saline Implant Foundation, "Supporting Survivors of Silicone/Saline Medical Implant Devices." I am not compensated or retained by industry or anyone else.

Society force-feeds us the definition of a beautiful body. Beautiful, young women grace the covers of magazines that line the supermarket’s check-out stand. Those images serve as a source of shame for those staring down at a bag of cookies sitting from and center in the grocery basket.

On the other hand, consider this: what you see is not what you always get. Advertisements paint a prettier picture that what reality oftentimes guarantees.

Your body is unique. It will carry you through every season of life, so why not take care of it? Taking care of your body is similar to taking care of your car. For your car to run properly, it must have gas in its tank and oil in its engine. The same is true for your body.

I would like to discuss Informed Consent issues to be considered. The manufacturers of Saline Breast Implants claim that women who get saline breast implants sign "Informed Consent" forms prior to their surgical procedure. How can a woman truly give INFORMED CONSENT if she is not provided with all information the manufacturers know about these products?

Rarely ever does a surgeon tell her:

1) These medical devices have never been approved by the FDA

2) There are numerous reports of silicone shells filled with medical grade isotonic saline causing autoimmune and other diseases,

3) All breast implants leak because the silicone shells are porous.

4) The silicone shell will ‘slough off’ silicone particles and may migrate throughout the body, and lodge in major organs.

5) The implant manufacturers, who advertised implants would last a lifetime, had actual knowledge that implants could fall apart after just 5-years.

6) The manufacturers of saline-filled breast implants never tested their products to determine if there would be long-term health-risks, prior to putting their implants on the market.

7) Sadly, no one tells her the children she might bear after implants were in her body could be affected by these products.

Any woman’s nightmare is just beginning when she decides to "take the chance" of having saline breast implants in her body. Within a short time of receiving breast implants, this formerly healthy individual may begin to have strange and unexplained medical problems. One day, her current doctor writes in his report that she has breast implants along with numerous health problems and BINGO -- no more health insurance. No one told her that within 2 years, she could be denied medical and life insurance coverage for the rest of her life -- simply because she once had breast implants. After hundreds of phone calls, she learns that her health insurance coverage was provided by companies who also insured the same breast implant manufacturers.

Manufacturers of Saline filled breast implants claim the women who get breast implants are provided package inserts prior to their surgical procedures. I PERSONALLY NEVER saw one. Furthermore, how can a woman truly give INFORMED CONSENT if she is not provided with the information the manufacturers knew about these products? Do these women have the right to receive this information? Absolutely! If any woman is told the truth -- that breast implants were never tested and determined to be safe for long-term human implantation; the implants would leak saline into her body; silicone from the implant shell could travel to her major organs; there was no way to ever get the silicone out of her body; the implants could begin to fall apart after 5 years, requiring additional surgical procedures; her children might be affected; and the long-term affects of implanted saline in silicone bags in the body were unknown -- a woman can weigh the risks and benefits of the surgical procedure -- and give Informed Consent. Any sensible woman, and most like her, would decline to take such risks.

What is wrong with hundreds of thousands of women whose only common denominator is silicone envelope saline-filled breast implants? On one hand, the implant manufacturers claim saline breast implants are safe and do not cause health problems. They claim these women have illnesses that don’t exist, diagnosed by "greedy doctors" taking advantage of a valid concern that this untested product "might" be the cause -- or at least a contributor -- to the medical problems the women are experiencing. Could thousands of doctors treating hundreds of thousands of women for the same, or similar problems be that wrong? Could laboratories all over the country testing and evaluating the blood and specimens from these women, be manipulating and orchestrating the test results -- so it appears these women have illnesses that don’t exist? Or, is it more likely, than not, the breast implant manufacturers have another reason to promote the fallacy of the illness that doesn’t exist?

Reasonable minds would wonder -- if silicone shell filled with "isotonic" saline filled breast implants are truly safe, and do not cause health problems, why is it the same insurance companies insuring the breast implant manufacturers refuse to pay health claims of women with breast implants? If saline breast implants are safe, why did the manufacturers only begin doing research on the long-term health consequences of their products after breast implants were removed from the market place? Or was that when they really began the research?

Do the insurance companies know something that other industries don’t know? Insurance companies have deemed women with implants, and those who have been explanted to be "uninsurable". This is only one reason the taxpayers are, and shall continue to bear the economic burden caused by these products. Why is there not accountability: Why are the manufacturers not called to task for creating the largest medical debacle in the history of our country?

This woman was declared totally disabled by many physicians in 1995. She has no income and no means to support herself. The money saved for her retirement was used for medical bills when her insurance coverage disappeared. Her mounting medical needs have caused undue financial and emotional strains on her family. This woman is one step away from being another drain on our society. It’s a disgrace because this could have been avoided. Had this woman received totally true Informed Consent about saline breast implants she would have never agreed to endure the surgical procedure. Today she would be a healthy, active, vibrant, productive member of society. She would still be the successful professional business woman and manager with an international brokerage consulting firm. She would have medical and life insurance coverage. Most importantly of all, she would have children living normal lives free of the illness that doesn’t exist.

If the members of the Senate and Congress are sincerely looking for the truth. Ask yourself, "How can so many women have an Illness that doesn’t exist, which can be diagnosed, quantified and qualified by scientists, epidemiologist, and researchers --- not to mention the treating physicians for these scores of women?"

The truth will never be found through research funded by the very manufacturers whose product has caused this Illness that doesn’t exist.

A 15 year old teen-ager made a decision to have plastic surgery to correct a congenital birth defect. This decision was only made after talking with her doctors and reading all the information she could get about the procedure. The doctors she consulted with told her that breast implants were safe and would last a lifetime. No one told her these medical devices had never been approved by the FDA. No one told her there had been reports of silicone causing autoimmune diseases. No one told her all breast implants leak. No one told her the silicone leaking from the breast implants would migrate through her body and lodge in all of her major organs. No one told her the implant manufacturers, who advertised implants would last a lifetime, had actual knowledge that implants could fall apart after just 5 years. No one told her the manufacturers of breast implants never tested their products to determine if there would be long-term health-risks, prior to putting implants on the market. And sadly, no one told her the children she would bear while implants were in her body could be affected by this product.

In 1998, she had her ruptured silicone breast implant replaced with a saline breast implant. She only had one on the right side due to her birth defect. From the day of the surgery in May, 1998 until it was removed in June 1999, she experienced constant pain and swelling. Every time she had to lift her arm or lay down the implant would shift incredibly and she would actually get a butterfly feeling in her stomach. Because the pain and discomfort was not diminishing, her surgeon decided the best solution would be to remove the saline implant.

After her explantation, she decided to have the implant analyzed by Dr. ----. This doctor found the Mentor Style 1600 with Catalogue number 350-1650 was defective with an incompetent valve which remained open. The implant was contaminated with material consistent with microbiological activity and debris. The implant weighed 10cc’s more than when it went in. She was lucky the saline implant was removed before it ruptured because she would have become extremely ill from the "junk" breeding inside the implant.

Did this woman have the right to receive this information? Absolutely! Unfortunately for this woman, and hundreds of thousands of other women like her, she did not receive the whole truth about the product her doctors recommended be placed in her body.

Respectfully,

Martha Murdock

4416 Willow Lane

Dallas, TX 75244-7537