News Roundup [abridged Versions Appear In The Paper Journal]

Europe plans tighter controls on breast implants

BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7289.754/a (Published 31 March 2001) Cite this as: BMJ 2001;322:754

CONCERNS FOR ESTROGENICY 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:

1. 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."

2. 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."

3. 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

4. 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 Care

Competing interests: No competing interests

03 April 2001
Martha Murdock
Executive Director
Dallas, TX 75244 - USA