The following is the draft of the proposed legislation:
Modernization Act for Womens Informed Consent for
Tubal Ligation and for all 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 Sterilization Syndrome" (PSS) aka "Post Tubal Ligation Syndrome" (PTS) or (PTLS); and,
WHEREAS, Post Sterilization 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 and medical battery.
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 female sterilization and 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:
- 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
Copyright © 2004 Susan J Bucher and the CPTwomen
Information for researchers:
IL NOW Tubal Ligation Resolution
Books/articles that describe post tubal syndrome (PTS)
"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."
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.
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.
To study the long-term risk of hysterectomy after tubal sterilization, the authors analyzed historical hospital discharge data on 39,502 parous women sterilized during 1971-1984 and 40,505 comparison women matched on age, race, parity, and interval since last birth.
Sterilized women were significantly more likely than were comparison women to undergo hysterectomy (relative risk (RR) = 1.35, 95% confidence interval (CI) 1.26-1.44), especially for diagnoses of menstrual dysfunction and pelvic pain (RR = 1.88, 95% CI 1.65-2.13). Higher relative risks were not associated with greater tissue-destructive methods of tubal occlusion. Relative risks were highest for women who were young on the reference date (RR = 2.45, 95% CI 1.79-3.36 for women aged 20-24 years), but declined steadily as age increased (RR = 0.96, 95% CI 0.72-1.28 for women aged 40-49 years). In all age groups, relative risks were significantly above 1.00 after 7 years of follow-up. Reasons for elevated risks may be related to a greater willingness of sterilized women to forgo their uteruses. The emergence of greater risk in all age groups, however, prevents the authors from ruling out a possible latent biologic effect of tubal sterilization.
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.
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.
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=
Zentralbl Gynakol. 1989;111(16):1124-7.
The effect of postpartum tubal sterilization on milk production
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.
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.
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."
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.
Katilolehti. 1998 Jan;103(1):9. Finnish. PMID: 9505666
[PubMed - indexed for MEDLINE]
Late effects of sterilization in women
Sterilization exerts a measurable effect on the ovaries,
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.
Image J Nurs Sch. 1992 Spring;24(1):15-8.
Post-tubal sterilization syndrome.
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.
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.
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.