In the 1960’s, as the Women’s Liberation Movement first desired decreased numbers of children, and then no children at all, the need for permanent sterilization was rapidly evolving. Women were getting blood clots, weight gain and strokes from the pill. The IUD that released progesterone was falling out of favor.
The “T-shaped” Intrauterine Device (IUD) Mirena ® was approved by the FDA in 2000. In December 2009, The FDA sent a warning letter to Bayer, complaining that its campaign had “serious misrepresentations” of side effects including life-threatening ectopic pregnancies, uterine or intestinal perforations, internal scarring, serious infections, risk of pregnancy, organ damage, post-operative surgical complications, Streptococcal sepsis, intensive care unit stays, and more.
Enter Essure: The Solution for Permanent Birth Control
On November 4 2002, Bayer acquired the Essure coil product from Conceptus and its use was FDA approved through a “preemptive” process called “Expedited Review”. Expedited Review usually means that the product has already been in use (e.g., in another country). The expedited review relies on data gathered from product use in other countries. The data presented to the FDA Panel are supposed to confirm the product’s use, safety, and effectiveness. We will see in subsequent posts that this was not the case for Essure. There were minimal data suggesting either the sufficient safety or efficacy to merit an expedited review.
The Good: How Essure was Supposed to Work
Components of each tiny Essure coil include a spine of stainless steel, covered by 24 coils of expanding and elastic outer coil of nickel titanium. It is covered inside and out with polyethylene terephthalate (PET) fibers, that are wound in and around the inner coil of stainless steel. The specific goal of the Essure PET fibers is to cause inflammation, induce scar fibers, and thereby block fertilization of the egg with the sperm.
The proper placement of the Essure Fallopian tube coil is such that it is screwed into the tube from inside the uterus, in a counter – clockwise fashion with no screwdriver needed. To do this, a surgeon uses a surgical instrument by hysteroscopy so that the coil fills the fallopian tube, dangling into the uterus. Next an ‘ejector’ shoots the coil in a little further; a quick ‘tug’ is supposed to ‘prove’ that it is correctly placed and will not migrate.
A hysteroscope is too fat to fit past the cervical os, where the sperm travel up, often times the doctor cannot see the two holes where the Fallopian tubes empty into the uterus. So the doctor inserts the hysteroscope under IV sedation or local anesthesia block, to make the uterus numb. The doctor then tries to find two little holes, one on each side of the uterus, where the Fallopian tubes empty into the uterus.
Once the coil placements are confirmed, the procedure is complete. But this is just the beginning. The insides of Fallopian tubes still need to undergo a process fibrosis, a local inflammatory response around the coils, so the Fallopian tubes are blocked off, or occluded (See Illustration 3). The blockage needs to be double-confirmed, so a special procedure is done after three months.
The patient is instructed not to have unprotected sex for three months. Over these three months, an alternative form of birth control must be used.
At the end of the three-month period, a confirmation test must be done to show that the coils have done their job by fully occluding and blocking the Fallopian tubes. There is no other way to do this than to perform a procedure called a hystero-salpingogram (HSG). The HSG uses dye injected past the vagina and cervix, past the uterus, and then hopefully it stops there, without going into the Fallopian tubes.
If the dye stays in the uterus and is blocked from going up both of the Fallopian tubes, the procedure is deemed a success and the patient is instructed that she can have unprotected sex now, because she can no longer have children.
If the contrast dye shows up inside the fallopian tube(s), however, then the patient can still get pregnant, and the coils have not finished doing their job at sclerosing the tubes shut. The doctor – patient relationship dictates what happens next; usually it is awaiting more time and then rechecking with another HSG at a later date. Although an area of controversy, removal of the coils is a possible choice.
The Bad: Side Effects of Essure
On the day of surgical placement, the most common side effects are: abdominal cramps, pain, and nausea/vomiting. Since the egg will still continue to be released each month at ovulation each month, the patient will still have her monthly period. The egg is simply reabsorbed into the body.
In 2013, Essure became a controversial procedure, with thousands of women complaining of complications leading to surgical removal, miscarriages with coils in babies’ ears, body hives, immune disease, coils breaking up into fragments, perforating the fallopian tubes, perforating the uterus, perforating the colon, pregnancies, severe abdominal bloating, pain on intercourse, general malaise, and even cancer. The first lawsuit against Bayer has been filed in 2014. Campaigner Erin Brockovich has taken Essure up as a cause, hosting her own website in the hopes of banning the product. Patients’ individual stories can be found here. Bayer continues to stand by its product, its safety, effectiveness, and reassures the public that it has a primary concern for public safety but that may not be enough.
If we look more closely at the Essure side effects, one thing becomes abundantly clear, they were predictable had anyone looked beyond the promise of ‘non-invasive’ sterilization. From the beginning, controlling the placement of the device within the Fallopian tubes was problematic and depended heavily on the surgical skill of the physician. Several studies indicate that correct placement occurred in only 84% to 98% of the cases. With perforation a likely outcome of a misplaced device, in a market of potentially millions of women, even a 2% failure rate is unacceptable. A 16% failure rate should give anyone pause; but it didn’t.
As difficult as that may be to accept, it seems that perforation may have been the least of the possible side effects. The chemical coating of the Essure device, meant by design to induce inflammation and scar tissue, was a toxicant itself; one that was inserted directly into the body.
The Ugly: Essure Chemical Coating
The Essure coils were coated in polyethylene terephthalate or PET fibers. PET fibers are plasticizers used in all sorts of commercial products. We recognize them by their brand names like Dacron (in the US), Terylene (in Briton) and Mylar under different conformational states. While these products are fantastic as outer coatings of materials to repel stains or water, as plasticizers that will degrade if exposed to heat and over time their usage in products that come in contact with food and/or are internalized is problematic to say the least.
The by-products of PET degradation, are acetaldehyde, a toxic intermediate in the metabolism of alcohol responsible for much of the liver disease in chronic alcoholics and antimony, a semi-metallic chemical element that is deleterious to health. Acetaldehyde is pervasive in airborne environments as a by-product wood smoke and other thermal reactions. Whether by inhalation or ingestion, acetyladehyde is a carcinogen. Should pregnancy occur in the presence of acetaldehyde exposure, it does cross the placenta and induce skeletal malformations, reduced birth weight, and increased postnatal mortality. Given its placement in the Fallopian tubes, follicular acetylaldehyde exposure could be predicted to induce changes in follicular morphology and perhaps even germ cell health for subsequent generations. Acetaldehyde is not something one wants leaching into the fallopian tubes, particularly when device placement is incorrect and pregnancy prevention nowhere near 100%.
Similarly problematic, Antimony leaching; antimony is a toxicant when applied topically. It induces local necrosis (cell damage and death). Systemically, continuous exposure to small amounts of antimony leads to an array of symptoms from cardiac to hepatic diseases similar to arsenic poisoning. Due to its very a very long half-life, antimony can induce reproductive disorders and chromosome damage. Antimony is toxic to reproduction with mutagenic and oncogenic potential.
Both degradation compounds have been found to leach into drinking water from plastic bottles exposed to heat (>65 degrees). Imagine how they might leach from a device placed into the Fallopian tubes where the temperature is ~98 degrees. There are no data regarding the degradation rate of the Essure coils or regarding the rate or risk of chemical exposure to women who used the device. Even when the device is placed appropriately and skillfully, and sterilization reached, the potential local and systemic exposure to PET degradation products should give anyone pause, but it did not.