H.R. 1321, the “Microbead-Free Waters Act of 2015,” became law Monday this week. The Act stops the “manufacture and introduction into interstate commerce of rinse-off cosmetics containing intentionally-added plastic microbeads.” The Act’s passage is a good thing for the environment, as these plastic beads are destructive to our lakes. Essure, Bayer’s “permanent” birth control device, contains polyethylene terephthalate (PET) fibers. These fibers are destructive to the human body, yet were approved for use in Essure, a permanent implant. It seems to boil down to waters vs. women: plastic beads and PET fibers. Now, environmental protection is a great thing, but so is protecting patient lives.

One manufacturer of PET clearly states in the product Material Safety Data Sheet (MSDS) that it is not for use in medical applications involving permanent implantation in the human body.

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Yet the FDA not only gave Essure’s originator, Conceptus, approval to market the product, the agency granted it pre-market approval status (PMA). This status prevents women who have been injured by Essure from seeking compensation via the legal system.

Surely, there were tests, right? There were tests, but Conceptus’ trials were fraught with deception and mismanagement. The FDA cited the company numerous times for these issues. Despite questionable research, the product is still on the market and women in the tens of thousands are being harmed. The primary function of the PET fibers in Essure is to stimulate an inflammatory process whereby the fallopian tubes become occluded (completely blocked) rendering the patient sterile. What else could be happening?

Some experts, such as Dr. Margaret Aranda, are expressing concerns over the possibility of PET degradation in the Essure coils. In food-grade applications, PET is known to degrade over time and when exposed to heat. Could this be happening with the PET in Essure?

In an article on the issue, Dr. Aranda writes:

“The by-products of PET degradation, are acetyladehyde, 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. Acetyladehyde 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 acetylaldehyde 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. Acetyladehyde is not something one wants leaching into the fallopian tubes, particularly when device placement is incorrect and pregnancy prevention nowhere near 100%.”

As stated previously, one PET manufacturer expressly states that the material should not be used as it is currently used in Essure. If you’re wondering about heat-induced degradation or think that it requires high temperatures, you’re in for a surprise.

Both acetyladehyde and antimony leach into drinking water from plastic bottles when the bottles are heated to temperatures 65 degrees Fahrenheit or greater. The temperature of the human body is approximately 98 degrees Fahrenheit.

I’ve yet to find data on PET degradation as it relates specifically to Essure. It is interesting, however, that many of the serious health issues caused by surgical mesh are being experienced by women with Essure. The materials used in the surgical meshes causing problems are from the same polymer “family” as the PET fibers used in Essure. This suggests that the PET fibers could be behind some of the many problems, including serious autoimmune disorders, being experienced by women using Essure. Further study is certainly needed.

While this piece raises more questions than it answers, I hope it serves as a starting point for discussion between patients and healthcare providers. With luck, it may also find its way into the hands of a researcher or two willing to investigate the issue.


Statement by the Press Secretary on H.R. 1321, S. 2425

Essure® Sterilization Coils: The Good, The Bad, and The Ugly

The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases

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