To all Representatives and
Lawmakers: Read the Open Letter
Draft of Proposed
Legislation:
Modernization Act for Women's Informed Consent for
Tubal Ligation and Fallopian Tube Devices for Contraception
WHEREAS, tubal ligation and medical devices which
affect the fallopian tubes for the purpose of birth control are conceived to be permanent
forms of birth control also known as tubal occlusion or sterilization; and,
WHEREAS, all forms of birth control list and disclose both risks and benefits of
each expect for sterilization. Information that is withheld from women regarding the side
effects of sterilization include information about long term physical and hormonal side
effects known commonly as Post Tubal Syndrome (PTS); and,
WHEREAS, Post Tubal Syndrome is known and understood by the medical community
but routinely this information is withheld from women. This constitutes forced or
fraudulent consent; and,
WHEREAS, some women are nervous while obtaining verbal information from their
providers, and or must see and hear information more than once, and or have poor hearing,
eyesight, or memories, and or need printed information in hand to discuss with loved ones
in order to wage their consent; and
WHEREAS, only with proper laws in place will women be protected from forced or
fraudulent consent to sterilization.
BE IT RESOLVED THAT UPON ENACTMENT OF THIS LAW:
It will be the responsibility of the provider performing the sterilization, the
hospital/surgical center, and involved insurance companies to ensure the patient is
informed in writing.
Providers shall give women "Take-Home-and-Keep Informed Consent"
outlining the risks and benefits of tubal ligation upon which to make informed decisions
to:
- All pregnant women at the time of their first consultation regarding their pregnancy.
- All women at the time of their first consultation regarding sterilization.
Hospital/surgical center scheduling departments shall mail "Take-Home-and
Keep Informed Consent" at the time the surgery/procedure is scheduled.
Insurance carriers, the day the procedure is pre-certified, shall mail
"Take-Home-and Keep Informed Consent" material and the Quality Assurance Review
Criteria to the involved insured woman.
Women consenting to medical devices permanently placed on or inside the fallopian tube
shall also receive in advance a duplicate of the package insert and full disclosure of the
safety studies, FDA approval status, chemical components, device longevity, human body
tolerance, manufacturer's/ distributor's name, address, phone number, and contact person.
All information shall be in printed form with no need to ask and shall be in the
person's native language.
Women signing consent papers for a sterilization procedure or occlusion devise shall be
in an unaltered state of consciousness, shall not be in any stage of labor or postpartum
euphoria, and shall not be on mind- or emotion-altering drugs.
No one shall provide "consent" for otherwise competent women who ordinarily
could give consent themselves but are rendered in an altered, semiconscious, or
unconscious state by medication and or are in mental, emotional or physical distress.
No one shall provide surrogate "consent" or involuntary "consent"
for a woman without a court order and the woman's knowledge.
The "Take-Home-and-Keep Informed Consent" shall include but not be limited
to:
- The type of sterilization to be done or the name of device that will be used.
- The name of the procedure in generally understood words;
- A description of how the procedure will be performed;
- The reason or indications and contraindications for the procedure;
- Whether the procedure is diagnostic, therapeutic, preventative, or cosmetic;
- Expected outcome concerning pain, function, and sensation;
- Possible risks - hormonal, physical, mental, psychological, emotional, and social;
- Possible complications, including infection rates and those documented and provided by
the Freedom of Information Act and provided by NLM, PubMed;
- Cost and expense;
- Average recuperation time
The signed legal consent shall name the procedure:
- In generally understood words.
- By official name, description, and computer code number exactly as it appears in the
Current Procedural Terminology book.
The signed legal consent shall name each and every "incidental" procedure,
including the creation of disfiguring scars by naming the incision, number, location, and
size, i.e., "2-inch horizontal band-aid belly button incision (laparoscopy) which
will be closed with invisible stitches under the skin, or visible stitches, visible
staples, or skin steri strip tape..."
Consent for "possible" procedures shall state the precise condition requiring
the "possible" procedure. The Operative Report shall give clear, cogent, and
indisputable photographic documentation of any unforeseen condition/s requiring the
consented "possible" procedure/s.
The signed legal consent shall name the primary and all assistant operators by their
full legal names and titles; shall clearly identify students/trainees, and whether they
are observers or operators; and shall clearly identify procedures new to seasoned
practitioners.
The signed legal consent shall state all known/possible benefits and risks including
but not limited to:
General information:
- Sterilization may improve economic status
The risks that can occur with all surgeries in general:
- General anesthesia risks
- Risk of infection
- Risk of adhesions
- Risk of bleeding
- Postoperative pain
The risks that can occur specifically with laparoscopic surgery (such as caused by
the Veress-needle/Trocar):
- Intestinal perforation (bowel injuries)
- Uterine perforation, abdominal wall emphysema, peritonism, mesosalpinx rupture
- Injury to the major retroperitoneal vessels (injury of a major blood-vessel)
- Perforation of an organ or vessels
- Fallopian tube rupture (tearing of the ovarian tubes)
- Risk of haemorrhages from salpinges on dissected Omentum
The risks relating to the sterilization process (that affecting the fallopian
tubes):
- Considered permanent. While reversal is possible in some instances, it is not a
guarantee.
- Risk of sterilization failure.
- If sterilization failure occurs then at higher risk of ectopic pregnancy.
- Risk of post-sterilization regret.
- Risk of post tubal syndrome (PTS) (altered ovarian function, menstrual abnormalities)
- Risk of disturbances of menstruation, dyspareunia and altered sexual life.
- Higher risk of subsequent hospital admission for menstrual disorders.
- Increase risk of hysterectomy.
- Risk of ovarian isolation to one or both ovaries (leading to ovarian failure), with
explanation why.
- Reduced risk of ovarian cancer, with explanation why.
- Risk of less milk production for lactating women.
Women shall also be informed that:
- The fallopian tube contains hormonal receptor cells, and can not be replaced once
removed.
- Sterilization does not protect from AIDS and STDs.
A written test shall document the comprehension of all informed consent material.
This will be completed and signed by the woman and will become part of the legal signed
consent.
BE IT FINALLY RESOLVED THAT,
Victims of forced, fraudulent, and incomplete informed consent to sterilization will be
protected by the full extent of the law.
Victims shall be treated or referred to affordable multidisciplinary physical, mental,
emotional, social, financial, legal, and support group help.
It shall be a crime to aid or cover up malfeasance; misrepresent the federal, state, or
hospital laws and bylaws; fail to halt, report, acknowledge and validate deviations from
standards of care; obstruct justice; refuse to diagnose or treat, dismiss as
"normal" or "mentally unstable"; or send victims back to the
perpetrator.
A violation of the Legislation shall constitute a reportable misdemeanor.
State Medical Boards shall forward all complaints concerning informed consent to
sterilization to their State Attorney General. The Attorney General and lawyers
shall enforce state law and file suits.
Respectfully submitted by,
Susan J Bucher
1629 S. Hamilton
Lockport, IL 60441
815 834-0987
e-mail: Susan@Tubal.org
Copyright © 2004 Susan J Bucher and the CPTwomen
Information for researchers:
IL NOW Tubal Ligation
Resolution
Books authored by noted physicians who describe post
tubal syndrome
Noted Articals:
"Post-Tubal Ligation Pain"
From IPPS - Simsbury Connecticut - April/May, 1999
OBGYN.net Editorial Advisors, James Carter, MD and Ahmed El-Minawi, MD, PhD
- Dr. El-Minawi: "...definitely - we believe in post-tubal ligation syndrome.
Most of the patients present with menstrual disturbances, usually menorrhagia,
menometromenorrhagia, and sorry to say - the majority of the patients ended up as
hysterectomy candidates...." "Most of them present anywhere between five
to ten years with an average of seven years following the surgery. Most of them have had
tubal ligations with destructive tubal ligation types, Pomeroy-type tubal ligations,
Irving-type tubal ligations; basically mid-segments tubal ligations are the worst type and
are the most causes of post-tubal ligation syndrome."
- Dr. Carter: "...a very high percentage of those women with post-tubal ligation
syndrome had adenomyosis." "...this finding of relationship with pelvic
congestion after tubal ligation, I believe, is a real problem. So if an individual has had
a tubal ligation 5-10 years prior, is experiencing more and more heavy bleeding, is
experiencing more and more pain, then in fact, they may have this syndrome."
http://www.obgyn.net/displaytranscript.asp?page=/avtranscripts/carter_elminawi
Am J Obstet Gynecol. 1992 Jun;166(6 Pt 1):1698-705;
discussion 1705-6
Tubal sterilization and risk of subsequent hospital admission for menstrual
disorders.
Shy KK, Stergachis A, Grothaus LG, Wagner EH, Hecht J, Anderson G.
Department of Obstetrics and Gynecology, University of Washington, Seattle 98195.
CONCLUSIONS: Tubal sterilization is associated with a greater risk of hospitalization
for menstrual disorders.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=1615977&dopt=Abstract
Am J Epidemiol, 1993 Oct 1, 138:7, 508-21
Long-term risk of hysterectomy among 80,007 sterilized and comparison women at
Kaiser Permanente, 1971-1987
Goldhaber MK; Armstrong MA; Golditch IM; Sheehe PR; Petitti DB; Friedman GD
Division of Research, Kaiser Permanente Medical Care Program of Northern California,
Oakland 94611.
http://home.swbell.net/birons/effects.htm
Evaluating the effects of tubal sterilization on
menstrual function:
selected issues in data analysis.
Martinez-Schnell B; Wilcox LS; Peterson HB; Jamison PM; Hughes JM
Division of Reproductive Health, Centers for Disease Control, Atlanta, Georgia 30333.
Source : Stat Med, 1993 Feb, 12:3-4, 355-63
Marginal modelling resulted in a statistically significant increase in the odds of
menstrual dysfunction at 5 years after tubal sterilization.
http://home.swbell.net/birons/effects.htm
Obstet Gynecol. 1998 Feb;91(2):241-6.
Higher hysterectomy risk for sterilized than nonsterilized women:
findings from the U.S. Collaborative Review of Sterilization.
The U.S. Collaborative Review of Sterilization Working Group.
Hillis SD, Marchbanks PA, Tylor LR, Peterson HB.
Division of Reproductive Health, National Center for Chronic Disease Prevention and Health
Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
CONCLUSION: Women undergoing tubal sterilization were more likely than women whose
husbands underwent vasectomy to undergo hysterectomy within 5 years after sterilization,
regardless of age at sterilization. An increased risk of hysterectomy was observed for
each method of tubal occlusion.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=9469283&dopt=Abstract
J Natl Med Assoc. 2001 Apr;93(4):149-50. PMID: 12653402
[PubMed - indexed for MEDLINE]
Fallopian tube necrosis after postpartum sterilization.
Poma PA, Barber A. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=12653402&dopt=Abstract
Zentralbl Gynakol. 1989;111(16):1124-7.
The effect of postpartum tubal sterilization on milk production
Vytiska-Binstorfer E.
Universitats-Frauenklinik, Wien.
We investigated 64 women after the so called "post partum sterilization" and
recorded also retrospectively the milk production within the first seven days. It was
performed by at semilunar subumbilical incision and a bipolar coagulation of the fallopian
tubes. The total daily milk production, which was compared with the quantity of milk after
the previous pregnancy, was on day six and seven significantly lower after tubal ligation
than in the normal puerperal phase before.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=2816156&dopt=Abstract
J Womens Health Gend Based Med. 2000 Jun;9(5):521-7. PMID:
10883944
[PubMed - indexed for MEDLINE]
Tubal ligation, menstrual changes, and menopausal symptoms.
Visvanathan N, Wyshak G.
Recently, there has been growing evidence that tubal sterilization protects against
ovarian cancer, possibly through physiological transformations that result in ovarian
dysfunction and decline. This report explores the possibility that the biological
mechanism of ovarian dysfunction and decline may affect the menstrual and menopausal
changes that result from hormonal imbalances.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=10883944&dopt=Abstract
Ginecol Obstet Mex. 2002 Jun;70:264-9. Spanish. PMID:
12148467
[PubMed - indexed for MEDLINE]
Relationship of bilateral tubal occlusion with functional ovarian cysts
de Alba Quintanilla F, Posadas Robledo FJ.
"…there is the chance of consequence and long term symptoms and this should
be informed to the patient."
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=12148467&dopt=Abstract
Eur J Obstet Gynecol Reprod Biol. 2002 Jan 10;100(2):204-7.
PMID: 11750966
[PubMed - indexed for MEDLINE]
The effect of surgical sterilization on ovarian function: a rat model.
Kuscu E, Duran HE, Zeyneloglu HB, Demirhan B, Bagis T, Saygili E.
CONCLUSION: Tubal ligation may affect ovarian function, which in turn may reflect to
ovarian histology in rats.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=11750966&dopt=Abstract
Katilolehti. 1998 Jan;103(1):9. Finnish. PMID: 9505666
[PubMed - indexed for MEDLINE]
Late effects of sterilization in women
Sumiala S.
Sterilization exerts a measurable effect on the ovaries,
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=9505666&dopt=Abstract
Obstet Gynecol. 1979 Aug;54(2):189-92.
Luteal deficiency among women with normal menstrual cycles, requesting reversal of
tubal sterilization.
Radwanska E, Berger GS, Hammond J.
Reduced midluteal serum progesterone concentration appears more common among women
with prior tubal ligation or electrocoagulation than among a control population of
apparently normal women.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&list_uids=460752&dopt=Abstract
Image J Nurs Sch. 1992 Spring;24(1):15-8.
Post-tubal sterilization syndrome.
Lethbridge DJ.
This article presents a review of the literature on post-tubal sterilization syndrome.
Although studies have shortcomings they suggest the majority of women undergoing tubal
sterilization do not experience changes in menstrual patterns after the procedure, but a
minority do. Suggestions are made for further research, conducted from a nursing
perspective. Implications for practice are suggested, given the tentative information on
post-tubal sterilization syndrome.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=
PubMed&cmd=Retrieve&list_uids=1541464&dopt=Citation
Adv Contracept. 1994 Mar;10(1):51-6.
Changes in ovarian function after tubal sterilization.
Hakverdi AU, Taner CE, Erden AC, Satici O.
Progesterone levels significantly decreased (p < 0.001) and anovulation was
observed in 13 (30.2%) of 43 cases. Our data suggest that tubal sterilization carried
increased risk in ovarian function, particularly luteal phase deficiency and anovulation.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=
PubMed&cmd=Retrieve&list_uids=8030455&dopt=Citation
TITLE: Risk and contraception: what women are not
told about tubal ligation.
AUTHORS: Turney L
SOURCE: WOMEN'S STUDIES INTERNATIONAL FORUM. 1993 Sep-Oct;16(5):471-86.
SECONDARY SOURCE ID: PIP/091715
ABSTRACT: The most common method of fertility control is tubal ligation. Physicians
and some women promote tubal sterilization as an extremely safe and very effective method
of permanent fertility control. Yet the medical profession has known since 1930 that
significant numbers of women suffer serious and irreversible complications from tubal
ligations; women have died from tubal ligation. Its mortality rates in Bangladesh, the UK,
and US, are 1/5000, 1/10,000, and 1/25,000, respectively. Women experience complications
both during and after surgery (e.g., twisting of the tube, sometimes accompanied by
gangrene, and accumulation of fluid in a tube). After tubal ligation, many women develop
endometriosis.
Torsion, hydrosalpinx, and/or endometriosis contribute
to increased menstrual pain. Disturbance of the local flora can cause sepsis (e.g., toxic
shock syndrome). Some women have a severe inflammatory reaction to the silicone in clips
and rings. Tubal ligation may be linked to an increased risk of cervical cancer. Many
sterilized women eventually undergo hysterectomy. Many women experience excessive bleeding
during menstruation, but many physicians discount this as women not knowing their own
bodies and subjective estimates of blood loss. Impaired ovarian blood supply and altered
nerve supply to the tube and/or ovary are possible causes for post-tubal ligation
menstruation problems. Many women experience memory loss, general decline in feeling of
well-being, lethargy, and loss of libido after tubal ligation, indicating a spontaneous
iatrogenic menopause. Yet physicians often attribute these symptoms to psychological
problems, thereby denying women knowledge of their own bodies. Tubal ligation-induced
problems should not be limited to the medical profession. We need to seriously examine
the processes that keep this information from women.
TITLE: Sterilisation of women [letter]
AUTHORS: Dickon S
SOURCE: NEW ZEALAND MEDICAL JOURNAL. 1987 Dec 9;100(837):755.
SECONDARY SOURCE ID: PIP/057531
ABSTRACT: There is some evidence that women who undergo tubal sterilization,
especially with cautery techniques, are at greater risk of subsequent hysterectomy. The
tubal surgery apparently interferes with the ovary's blood supply, leading to decreased
hormonal output, irregular ovulation, and an abnormal pattern of uterine bleeding that
becomes the basis for the need for hysterectomy. Given this evidence, it is appalling to
find that New Zealand women are being encouraged to undergo tubal ligation without any
counseling regarding the chance of heavy bleeding problems within 5-10 years. Moreover,
the alternative of having the male partner seek vasectomy is rarely presented. It is
the duty of gynecologists to give this problem more attention in pre-sterilization
counseling sessions. Useful toward this end would be a leaflet that could be given to
patients at the time of their 1st consultation outlining the risks and benefits of tubal
ligation.
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