Concerns for the Estrogenicity of Silicone Breast Implants

[Guest guest]

Concerns for the Estrogenicity of Silicone Breast Implants

I have a very strong concern for the estrogenicity of the chemical contents in silicone breast implants. My concern comes from the 1975 Copenhagen Study where estrogenic effects of 2,6-cis-Diphenylhexamethylcyclotetrasiloxane, which was documented in rabbits, dogs, monkeys, rats, and men with end-stage prostate cancer. This study also showed that in rats, 2,6-cis-D---"Obviously passed the placental barrier, a fact to which special attention should be paid."

As a Women's Health Care Nurse Practitioner, I cannot figure out why women of child bearing age or women who have had, or are at risk, for developing estrogen receptive cancer should be exposed to such a chemical or device that does not provide an essential life saving function.

In 1998, there are nonsteroidal synthetic estrogens, conjugated estrogens, and selective estrogen receptor modulators, which are widely used in women's health care. When considering using these drugs, one should always consider absolute contraindications, relative contraindications, pregnancy category in reproductive women, and the impact on lactation. There is not one of the aforementioned drug classifications that have a pregnancy category of less than 'X'.

Some considerations for these drugs are breast cancer, thromboembolic disorders, reproductive cancer, genital bleeding (undiagnosed), and hepatic tumors. It concerns me that these same considerations are not applied when a patient is considering silicone breast implants, if in fact, the chemicals are as estrogenic as they were found to be in 1975. I would expect that in 1998, a study could be constructed to detail the exact estrogen receptive sites that 2,6-cis-D, or any chemical of concern, in silicone breast implants would impact, whether it be bone, endometrium, breast, colon, brain, skin, eyes, or fetal development. It is also well documented in the literature that estrogens can exacerbate or initiate flares of autoimmune disease. My hope is that this committee will see the concern that I have for women who have implants or may receive implants, and the many important questions that have been left unanswered for the last 25 years that could be resolved with unbiased scientific research.

I would like to briefly point out a few findings from the 1975 Copenhagen study:

Chapter VI. The Antigonadotropic Activity of an Organosiloxane in the Male Rat -- "On this data it was postulated that this unusual nonsteroid structure exerts its effects at the level of the anterior pituitary and on the hypothalamus."

Chapter VIII. The Hormonal and Antifertility Activity of 2,6-cis-D, in the Female Rat---"The primary effects appeared to be accelerated passage of the ova to the uterus and induction of ovum destruction in the oviduct." This sounds similar to the effects of emergency contraception dosing of estrogen used in the U.S. today --- "administration of cyclic 2,6-cis [(PhMeSiO)2](Me2SiO] at other times during gestation terminated pregnancy during primitive streak and neurula stages (days 8-11). Gestation was sensitive to organosiloxane treatment during implantation. Pregnancy was not terminated after day 11. Thus, this purely organosilicon compound represents a new class of moderate estrogens and may be useful in the study of estrogen structure-activity relationships."

Chapter X. The Distribution of C-labeled KARI 1774 --- The results showed that the substance disappeared from the blood in 3 to 12 hours. It was then found in many organs to different degrees, depending on the time intervals. These systems included: skeleton, digestive, urinary, reproductive, respiratory, endocrine, and the liver of fetuses.

Concerns for the Estrogenicity of Silicone Breast Implants

Chapter XI. Pharmacokenetics of 2,6-cis-D. In Man -- "During the time of medication, which varied between 1 and 5 months, the general condition of the patients improved, especially of patients #2 and #3, and the severe pain from which they suffered initially was relieved. During the time of observation, there were no side effects and no changes in routine blood chemistry. In two patients a reduction in the size of the external genitalia was noted."

With results like these from this study, I cannot understand how these implants could have been brought to market in the U.S. without further research being done to either validate or disprove the estrogenicity of the chemical in question. However, Dow Corning did not have this research done in the U.S. They had it done in another country and never followed through with recommendations given in the study.

If this Committee is successful in initiating research on this particular area of concern, one of my biggest wishes is that the information get into the journals of the primary care doctors and OB/GYNS. These are the physicians that are seeing these ladies on a regular basis. I personally hate to hear physicians use the phrase, "I am unaware of that being a problem or concern, maybe you should go see a specialist about that." This is a commonly used phrase that neither affirms nor denies the issue, however, it does release the physician who is being addressed from liability as long as it is not common knowledge in their field of practice. Women deserve better answers to their health care questions than that.

Lastly, I would like to request that all women who are considering undergoing treatment for a non-emergent, non-life-threatening condition where implantation of breast implants are a choice, be completely informed of ALL the risks -- and that they are detailed to each patient in a Standardized Consent Form that cannot be altered from one doctor to another. Women who have breast implants have given up individual and independent control of their health by being implanted.

Example: If a woman has a side effect or reaction from a medication, it can be stopped, whether she chooses not to swallow another pill, take another injection or terminate an infusion, with little difficulty. It is, on the other hand, not easy to change one's mind about one's implants. This requires surgical intervention with anesthesia. These surgeries cost several thousand dollars, often much more than the initial implant cost, and can be an excluded service, not covered by insurance, even in the event of a complication.

I see women on a daily basis who have multiple concerns for the contraceptives, hormone replacement therapy, or antibiotic I prescribe, but would never question their plastic surgeons in regard to their breast implants. These women deserve to know the truth about all the multiple medical aspects of breast implants, whether it is systemic, local, or second generational.

My prayer for each of you on this Committee is that you will bring your expertise and wealth of knowledge together to create a breakthrough that will positively impact the health of women who have, who have had, and who are considering silicone and saline breast implants.

To I.O.M./N.A.S Committee Respectfully submitted by: Arden R. Moulin, R.N.C., W.H.N.P. Women's Health Car

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537

[Guest guest]

FYI! For the 'Newbies'

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537

----- Original Message ----- From: MARTHA

Cc: BreastImplantNews

Sent: Sunday, August 18, 2002 1:33 AM

Subject: "Concerns for the Estrogenicity of Silicone Breast Implants"

Concerns for the Estrogenicity of Silicone Breast Implants

I have a very strong concern for the estrogenicity of the chemical contents in silicone breast implants. My concern comes from the 1975 Copenhagen Study where estrogenic effects of 2,6-cis-Diphenylhexamethylcyclotetrasiloxane, which was documented in rabbits, dogs, monkeys, rats, and men with end-stage prostate cancer. This study also showed that in rats, 2,6-cis-D---"Obviously passed the placental barrier, a fact to which special attention should be paid."

As a Women's Health Care Nurse Practitioner, I cannot figure out why women of child bearing age or women who have had, or are at risk, for developing estrogen receptive cancer should be exposed to such a chemical or device that does not provide an essential life saving function.

In 1998, there are nonsteroidal synthetic estrogens, conjugated estrogens, and selective estrogen receptor modulators, which are widely used in women's health care. When considering using these drugs, one should always consider absolute contraindications, relative contraindications, pregnancy category in reproductive women, and the impact on lactation. There is not one of the aforementioned drug classifications that have a pregnancy category of less than 'X'.

Some considerations for these drugs are breast cancer, thromboembolic disorders, reproductive cancer, genital bleeding (undiagnosed), and hepatic tumors. It concerns me that these same considerations are not applied when a patient is considering silicone breast implants, if in fact, the chemicals are as estrogenic as they were found to be in 1975. I would expect that in 1998, a study could be constructed to detail the exact estrogen receptive sites that 2,6-cis-D, or any chemical of concern, in silicone breast implants would impact, whether it be bone, endometrium, breast, colon, brain, skin, eyes, or fetal development. It is also well documented in the literature that estrogens can exacerbate or initiate flares of autoimmune disease. My hope is that this committee will see the concern that I have for women who have implants or may receive implants, and the many important questions that have been left unanswered for the last 25 years that could be resolved with unbiased scientific research.

I would like to briefly point out a few findings from the 1975 Copenhagen study:

Chapter VI. The Antigonadotropic Activity of an Organosiloxane in the Male Rat -- "On this data it was postulated that this unusual nonsteroid structure exerts its effects at the level of the anterior pituitary and on the hypothalamus."

Chapter VIII. The Hormonal and Antifertility Activity of 2,6-cis-D, in the Female Rat---"The primary effects appeared to be accelerated passage of the ova to the uterus and induction of ovum destruction in the oviduct." This sounds similar to the effects of emergency contraception dosing of estrogen used in the U.S. today --- "administration of cyclic 2,6-cis [(PhMeSiO)2](Me2SiO] at other times during gestation terminated pregnancy during primitive streak and neurula stages (days 8-11). Gestation was sensitive to organosiloxane treatment during implantation. Pregnancy was not terminated after day 11. Thus, this purely organosilicon compound represents a new class of moderate estrogens and may be useful in the study of estrogen structure-activity relationships."

Chapter X. The Distribution of C-labeled KARI 1774 --- The results showed that the substance disappeared from the blood in 3 to 12 hours. It was then found in many organs to different degrees, depending on the time intervals. These systems included: skeleton, digestive, urinary, reproductive, respiratory, endocrine, and the liver of fetuses.

Concerns for the Estrogenicity of Silicone Breast Implants

Chapter XI. Pharmacokenetics of 2,6-cis-D. In Man -- "During the time of medication, which varied between 1 and 5 months, the general condition of the patients improved, especially of patients #2 and #3, and the severe pain from which they suffered initially was relieved. During the time of observation, there were no side effects and no changes in routine blood chemistry. In two patients a reduction in the size of the external genitalia was noted."

With results like these from this study, I cannot understand how these implants could have been brought to market in the U.S. without further research being done to either validate or disprove the estrogenicity of the chemical in question. However, Dow Corning did not have this research done in the U.S. They had it done in another country and never followed through with recommendations given in the study.

If this Committee is successful in initiating research on this particular area of concern, one of my biggest wishes is that the information get into the journals of the primary care doctors and OB/GYNS. These are the physicians that are seeing these ladies on a regular basis. I personally hate to hear physicians use the phrase, "I am unaware of that being a problem or concern, maybe you should go see a specialist about that." This is a commonly used phrase that neither affirms nor denies the issue, however, it does release the physician who is being addressed from liability as long as it is not common knowledge in their field of practice. Women deserve better answers to their health care questions than that.

Lastly, I would like to request that all women who are considering undergoing treatment for a non-emergent, non-life-threatening condition where implantation of breast implants are a choice, be completely informed of ALL the risks -- and that they are detailed to each patient in a Standardized Consent Form that cannot be altered from one doctor to another. Women who have breast implants have given up individual and independent control of their health by being implanted.

Example: If a woman has a side effect or reaction from a medication, it can be stopped, whether she chooses not to swallow another pill, take another injection or terminate an infusion, with little difficulty. It is, on the other hand, not easy to change one's mind about one's implants. This requires surgical intervention with anesthesia. These surgeries cost several thousand dollars, often much more than the initial implant cost, and can be an excluded service, not covered by insurance, even in the event of a complication.

I see women on a daily basis who have multiple concerns for the contraceptives, hormone replacement therapy, or antibiotic I prescribe, but would never question their plastic surgeons in regard to their breast implants. These women deserve to know the truth about all the multiple medical aspects of breast implants, whether it is systemic, local, or second generational.

My prayer for each of you on this Committee is that you will bring your expertise and wealth of knowledge together to create a breakthrough that will positively impact the health of women who have, who have had, and who are considering silicone and saline breast implants.

To I.O.M./N.A.S Committee Respectfully submitted by: Arden R. Moulin, R.N.C., W.H.N.P. Women's Health Car

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537