Female Sterilization (Essure, Adiana, Ovabloc [1,2], Filshie/Hulka clips) Post Tubal Ligation Syndrome (PTLS) and the risk of "Post Implant Syndrome" (PIS)
by Susan Bucher, BSN
When female sterilization is carried out using an implanted medical device such as Essure or Filshie clips there is the added risk of "Post Implant Syndrome"
All forms of female sterilization have known and potential negative side effects(sequelae) known as post sterilization syndrome or post tubal ligation syndrome (PTLS) which women need to be informed of prior to consenting to sterilization. For example, women need to be informed that female sterilization can cause hydrosalpinx (3) (4), fallopian tube torsion, and adnexal torsion causing pain. Female sterilization can also cause the condition of adenomyosis and pelvic congestion syndrome which manifests as pain and dysfunctional uterine bleeding (DUB) (excessive bleeding) which may require surgical remedies or complete hysterectomy to correct. Also important to understand is female sterilization/tubal ligation procedures can affect the blood supply to the ovaries causing anovulation (ovaries failing to normally function or to ovulate), premature ovarian failure (POF), or surgical menopause (female castration). When the sterilization is carried out using an device such as Essure, Adiana, Ovabloc, Filshie clips or Hulka clips, there is the added risk of "Post Implant Syndrome (PIS)".
Any type of medical device which is implanted into a body (a dental implant, breast implant, heart stent, a device used for the purpose to sterilize women, etc.) carries the risk of rejection and a post implant syndrome (hypersensitivity reactions/autoimmune syndromes) could manifest.
Post implant syndrome or post-implantation syndrome (PIS) refers to the cutaneous (relating to/or affecting the skin) and systemic hypersensitivity reactions/delayed hypersensitivity reactions (DHR) and autoimmune syndromes which arise after a metal (nickel, titanium, etc..), silicon/silicone, or other man made material/foreign object is medically implanted into the human body for therapeutic or cosmetic purposes.[5,6] As a response to a foreign object being implanted into the body the immune system can become overwhelmed which can result in immune system dysfunction and auto-immune conditions/symptoms manifesting. For example, silicon exposure is associated with different systemic autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, progressive systemic sclerosis, and vasculitis.[7] When titanium dioxide (TiO2) is implanted in the body it oxidizes into titanium ions (Ti2+) which is absorbed and distributed throughout the circulation into various tissue beds, including the liver, spleen, lung, and peritoneal tissue.[8] The most common form of metal hypersensitivity is contact dermatitis due to nickel.[9]
Filshie clip: Femcare-Nikomed states that the titanium in the clip does not contain nickel but that the silicone used to manufacture the clip "does contain trace levels". CooperSurgical states, “The silicone and titanium used in the manufacture of the Filshie Clip are generally regarded as safe materials for human implantation. Although no adverse toxic or tumorigenic effects due to the device or its materials have been reported, the effects of long term implantation are unknown. “
Hulka clips: Hulka clips contain metal with gold covering which some women are senitive to. In 2014 there was a Hulka clip recall reported as failed biocompatibility testing on a component used.
Essure: The Essure micro-insert is made from a nickel-titanium alloy. The manufacturer states that this metal is “generally considered safe” but goes on to explain that, "in vitro testing has demonstrated that nickel is released from this device. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some patients may develop an allergy to nickel if this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus, and hives.” Because the device contains a known allergen it has been advocated that a patch test be peformed before its use. Click here for more information on nickel allergy.
Essure coils are also made with polyethylene terephthalate (PET) fibers.
PET (polyethylene terephthalate) is a plastic resin that, according to the material safety data sheet (MSDS) of one manufacturer, should not be used for “medical applications involving permanent implantation in the human body.” Polyethylene Terephthalate (PET) may yield endocrine disruptors.[10] Bayer admits Essure causes autoimmune disorders.
Post-implantation syndrome (PIS) manifesting as delayed hypersensitivity reactions (DHR) and autoimmune syndromes has been studied and reported upon by the mainstream medical community for all types of therapeutic and cosmetic implants (breast, dental, hip, heart valve, etc..), but has NOT been reported upon publicly regarding medical devices used for the purpose of "female sterilization".
Withholding information and not informing women in advance of the post tubal ligation syndrome (PTLS) risks of sterilization or that a medical device to be implanted carries the risk of post implant syndrome (PIS) is a crime of omission which leads to battery.
Even more disturbing is the fact that it is commonplace for gynecological sterilization devices, primarily the Filshie clip, to be placed in women without their knowledge.
The CPTwomen (tubal.org) has received thousands of complaints from women after learning that filshie clips were placed without their consent or knowledge. These women believed they were going to have their tubes “cut and tied” only to find out after the fact (sometimes years later) that a medical device was placed within their body. This is yet another crime of omission and battery.
It is customary and by law required for physicians to discuss in advance and inform a patient how an elective procedure will be performed and if a medical device will be left in place.
If a doctor plans to use (or if there is any remote possibility the doctor will use) “Filshe Clips” (or any type of medical device which will be left in the patients' body), this must be disclosed to the patient in advance when consulting for sterilization. Filshie clips (as well as Essure and IUDs, etc.) not only can trigger hypersensitivities (PIS), they can come dislodged, migrate, implant into other part of the body, and can even be expelled vaginally. The fact that these gynecological devices are known to migrate and implant into non-targeted areas of the body causing pain and mayhem puts a second meaning to the term "Post Implant Syndrome".Theomission regarding the device risks, or that the device is going to be implanted is an obvious breach of the “duty of disclosure” and a criminal act of battery when the device is placed without the woman’s consent or knowledge. This is in addition to the batteries committed by the omissions of the sterilization risks (PTLS) in general.
The following is an example of what some women have reported concerning the omission of information and placement of Filshie Clips.
The following conversation began on January 3, 2016:
S.B.: I would like to open a dialogue for women who found out months afterward that they had Filshie Clips placed and didn’t know it.
M.V.: This X-ray was 9 months after my Tubal Ligation which I had done for pelvic pain. This x-ray came back “normal” by the way… 2 1/2 years later; I requested all of my X-rays, CTs, MRI, anything that I had only to find this (that clips were placed without my knowledge). During surgery to remove the clamps, one clamp had been found embedded into tissue in my lower stomach.
M.H.: I had clips placed and didn’t know until I went back for my 6 week check up. I thought I was cut tied and burned which is what I had discussed with my doctor at our first visit. S.S.: I didn’t know either!! They gave me a pic after surgery and I was so mad!! D.P.: I had no clue until three months after my surgery. A.B.: Didn’t know til my six week check up!! Thought I (had a) regular tubal. M.K.: I had no idea either until afterwards. I thought they were cut and tied. S.B.: I had no idea about mine until I asked for surgery report S.S.: So many of us were not told!! M.T. : I was told I would be cut tied and burned until I got my surgery report 4 months later A.W.: I didn’t know I had the Filshie Clips until 3 years after my TL. I was told it would be a regular cut, tie & burn. I never had any notice of metal being placed in me, and no testing afterwards to see if it worked. I found out due to an x-ray where the tech asked if I was wearing pants because the “zipper” was in the way. I told them I wasn’t and they said that I had some weird metal in me. I requested my operative report after. During my cyst removal they found some floating around in my abdomen. N.F.: Didn’t know I had Filshie clips until getting my report almost 2 years after, I thought I was being cut, tied and burned…. G.B.: I didn’t find out that I had Filshie clips till 2 yrs ago. How’s that for things? M.C.: I also was not aware of the clips being put in. I was under the impression that they were doing a cutting and burning of the tubes ..was not told until I was in recovery.
Women are Unaware They are Victims of Crime
When learning that information was (and is) withheld from them, women in the USA today do not immediately equate this to having been a victim of physical assault and battery nor completely understand that they were forcibly sterilized because they were not carried away forcibly to the operating table kicking and screaming. Women in the USA are led to the operating table for sterilization with a metaphoric blindfold on; placed upon them by their obgyn caregiver(s) using omission.
Women are not informed of the risks before,nor are they informed afterwards when they return to the same doctors complaining of a change in their health. Afterwards women are told that their sterilization (and medical devices) had no bearing on their change of health status (pelvic pain, hot flashes, irregular cycles, missed cycles, autoimmune conditions, etc…). Physicians continue with more omissions with statements that sterilizations and medical devices don’t cause such conditions and decline to diagnose or medically treat women appropriately after sterilization. This is inline with the code of silence which governs sterilizations and in turn imprisons women (physically and mentally) within their iatrogenic condition causing further abuses and batteries.
Denial of diagnosis (determining cause of pain/symptoms, testing for hormonal imbalance, testing for autoimmune disease, etc…) and denial of treatment (relief from pain, providing appropriate hormone replacement [not just giving the “pill”]) involves the act of omission and is a criminal act of battery.
OBGYNs not informing women of known risks before sterilization and not diagnosing women or treating them for conditions created by the sterilization afterwords are both crimes of omission (failure to act) and is grounds for criminal liability. ~ Dr. Vikki Hufnagel, MD
"These batteries all occur in secret behind closed doors covertly in doctors examining rooms and in hospital operation rooms. These batteries do not leave outwardly signs of broken bones and bruises to the face and body that husbands and the public can view, but is all internal which adds to the surreptitiousness of the abuse, batteries and harm". ~ Susan Bucher, BSN
Issues of Consent:
Physicians are required by law to inform and advise patients about the consequences and risks of medical procedures and medical devices which will be implanted. For elective surgery this means even remote risk (statistics are irrelevant). All forms of birth control list and disclose both risks and benefits of each expect for sterilization. Post Sterilization Syndrome aka Post Tubal Ligation Syndrome (PTLS) and Post Implant Syndrome (PIS) is known and understood by the OBGYN medical community but in a widespread systematic way this information is routinely withheld from women at the time of consent. Withholding information creates a cycle of abuse surrounding female sterilization.
In Texas, informed consent for sterilization is listed on their “A” list which “requires full and specific disclosure”.
The required disclosure for tubal sterilization are: A — Injury to the bowel and/or bladder B — Sterility C — Failure to obtain fertility D — Failure to obtain sterility E — Loss of ovarian functions or hormone production from ovary(ies).
These disclosures are NOT printed on the informed consent, but left to the “contractors” (OBGYNs) who perform the procedure to disclosure to the women. This creates conflict for these doctors who are governed by and operate under a code of silence. In Texas women are NOT informed of the risk of losing ovarian function. Women in Texas are also NOT informed of post sterilization syndrome, post tubal ligation syndrome (PTLS), or post implant syndrome (PIS) when a medical device is implanted. In some cases (as explained above) women are not even informed that a device is going to be (or was) implanted.
Lack of adequate disclosure and withholding medical information is a deceptive practice done to sell the elective procedure/surgery/treatment/device and to persuade/compel women to make the decision that the doctor wants them to make. In doing so the physician and others benefit and profit. The act of withholding information is an attack directed against women, disables her decision process, distorts her choice, puts her at a disadvantage, and creates for her a disability. The mere fact that the woman might refuse treatment is not sufficient to act as a justification for nondisclosure of information, limited disclosure, or therapeutic privilege.
Key Issues:
Policy - Obtaining valid consent before carrying out medical, therapeutic and diagnostic procedures has long been recognized as an elementary step in fulfilling the doctor's obligations to the patient.
Ethics - Withholding information from patients is ethically unacceptable. The notion of consent is grounded in the ethical principles of patient autonomy and respect for persons. "Autonomy" refers to the patient's right to make free decisions about his or her health care. Respect for persons requires that health care professionals refrain from carrying out unwanted interventions and that they foster patients' control over their own lives.
Law: Negligence - It is the treating physicians’ legal requirement to present all risks and benefits and obtain the patient's informed consent before providing treatment. Treating a patient on the basis of inadequately informed consent constitutes negligence. If the patient has been lied to about the treatment or there is other fraud in the informed consent, then the entire consent is invalid.
Law: Battery - Treating a patient without her full informed consent (or with invalid consent) constitutes battery. Battery is committed even if the doctor acts in the patient’s best interest.
Female sterilization in all cases is directed to be an elective choice to be decided by the woman alone at her own free will after information is presented detailing all known benefits and possible risks and while not in duress or distress.
Coercive sterilization is a grave human rights violation that is frequently targeted at women from marginalized segments of society. Coercive sterilization often occurs while a woman is giving birth or soon after, when she is in a position of powerlessness at the hands of healthcare providers.
Informed consent means the knowing consent of an individual (or their legally authorized representative), so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or any form of restraint or coercion.
For consent to be valid a patient must have
capacity
it must be voluntarily given
there should be no duress
information regarding risks, benefits, side-effects and alternatives (regarding the procedure and about any devices which will be implanted) must be given so that the patient is able to make an informed decision as to whether or not to proceed with treatment
Consent cannot be obtained from a woman who is
in an altered state of consciousness
in any stage of labor or postpartum euphoria
while in a state of extreme fatigue or sleep deprived
on mind- or emotion-altering drugs
Withholding information about known possible side effects (of the procedure or about the device planned to be used) and/or obtaining consent while a woman is in labor, while a woman is on opiate pain medication (or in an altered state of consciousness), or when a woman is under undue duress or distress all constitutes forced (fraudulent/coerced) consent and in all accounts (figuratively and legally) is battery (committed by the person who performs the sterilization)
The Ongoing Abuses, Batteries & Crimes of “Omisson”
The ongoing abuses and batteries which are occurring today in 2016 concerning female sterilization include:
Not informing of the risks of female sterilization (post sterilization syndrome [PTLS]) by those who have a duty to do so (OBGYNs). Key information which is withheld includes risk of the sterilization causing a hormonal imbalance or castration (ovarian failure)and risk of late sequelae chronic acute pain and bleeding disorders developing leading to hysterectomy.This omission by physicians is an obvious “breach of the duty of disclosure” and a criminal act of battery at the time of sterilization.
Not informing of the risk of "implant syndrome" by those who have a duty to do so (OBGYNs) when a medical device is used to perform the sterilization (Essure, clips, etc.). This omission by physicians is an obvious “breach of the duty of disclosure” and a criminal act of battery at the time of sterilization when the device is implanted.
Women being given consents to sign during labor.
Filshie Clips (and other medical devices) being placed without consent or knowledge.
“Withholding information from women regarding negative side effects to female sterilization is a misogynistic and barbaric practice.
It's as barbaric as female genital mutilation (FGM) as both relate directly to physical battery.” ~ Susan Bucher, BSN
In Summary:
The obligation to disclose information rests on both ethical and legal foundations but ask any woman today (in 2016) what she was told of female sterilization (tubal ligation, Essure, clips or salpingectomy) in advance and you'll learn that adverse outcomes such as ovarian isolation (causing ovarian failure and hormonal imbalance), bleeding disorders (causing pain), migrating clips, broken/migrating Essure/clips (causing mayhem/leading to hysterectomy), post sterilization syndrome or the risk of “implant syndrome” with allergies or autoimmune conditions developing are NEVER disclosed. Not informing women of the risk of post sterilization syndrome, post tubal ligation syndrome (PTLS), and that the medical device that will be used (be it Essure, filshie clips, an IUD, or other) could cause a hypersensitivity reaction or trigger an autoimmune disease (post implant syndrome [PIS]) is a crime of omission which leads to battery which stems from a cycle of abuse. It is commonplace for medical devices for the purpose of sterilization to be placed without women’s knowledge which again is a crime of omission and battery. Informed consent is lacking to the point of criminal actions and batteries occurring. Until law is created to protect women that ensures all the known and possible risks of female sterilization is disclosed at the time of consent, ALL women who are sterilized are (and will be) a victim of battery.
Support Informed Consent for Female Sterilization (Tubal Ligation, Essure, Clips)
Medical implants causing systemic hypersensitivity reactions and autoimmune syndromes aside, the fact that gynecological devices used for the puropose of birth control and female sterilization (Essure, Filshie clips, IUDs, etc.) are known to migrate and implant into non-targeted areas of the body causing pain and mayhem puts a whole new meaning to the term "Post Implant Syndrome". ~ Susan Bucher, BSN
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