Essure, the 'Tube Tying' Alternative: Not Just a Cork in the Bottle

Two weeks ago a variety of experts and patients met to testify to a Food and Drug Administration advisory panel about concerns that the female sterilization device Essure is causing more problems than the FDA or Bayer, the manufacturer of the device, are admitting to.
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Two weeks ago a variety of experts and patients met to testify to a Food and Drug Administration advisory panel about concerns that the female sterilization device Essure is causing more problems than the FDA or Bayer, the manufacturer of the device, are admitting to.

A non-surgical alternative to a "tube-tying" tubal ligation, the device is inserted into the fallopian tubes, thereby preventing egg and sperm from ever hooking up. The cork in the bottle is the Essure micro-insert, a spring-like device made of a stainless steel inner coil, a nickel titanium expanding outer coil, and polyethelene terephthalate (PET) fibers.

Some of the symptoms described by Essure patients appear to be local and more mechanical in nature: pelvic pain, heavy and/or painful menses, a device that had dislodged and migrated. Other complaints have been more body-wide and perhaps inflammation-related: eczema, lupus, celiac disease, muscle weakness and debilitating fatigue, headaches.

Although the cause-and-effect relationship of these possible side effects has yet to be determined (proponents lobbied the FDA to monitor the device more closely, protesters to pull it), it's no stretch to think that the Essure micro-insert might cause inflammation. Because inflammation is part of how it works. As stated in Essure's pre-market approval application to the FDA, inflammation is necessary to reliably and fully seal off the fallopian tubes.

"The effectiveness of the Essure micro-insert in preventing pregnancy is believed to be due to a combination of the space-filling design of the device and a local, occlusive, benign tissue response to the PET fibers. The tissue response is the result of a chronic inflammatory and fibrotic response to the PET fibers."

As Bayer describes it, the polyethelene terephthalate fibers are what's stimulating this "benign" inflammation. What is polyethelene terephthalate (PET)? It's the most common form of polyester. As a ubiquitous member of modern life, it may be most widely recognized as the material in any recyclable plastic bottle with a #1 on it. PET has been used in other medical devices, so this application isn't novel.

But the possibility that the nickel in Essure's nickel titanium (Nitinol) coils is triggering an allergic response in nickel-sensitive patients drew a lot of attention at the FDA hearing.

Dr. Peter Schalock, a dermatologist at Massachusetts General Hospital and a member of the expert panel, asked, "How can Bayer and the FDA have no knowledge of nickel allergies?" It was likely a rhetorical question, as if to ask why they didn't take the possibility of nickel allergies more seriously; because as Schalock certainly knows, nickel is the most common metal allergy, reported in 7-11 percent of the population.

As Bayer is quick to point out, nickel (in the form of various alloys) has been a very common metal in implantable medical devices. Stainless steel is around 15 percent nickel, and today's coronary artery stents are typically made from cobalt alloys that are anywhere from 10-35 percent nickel. U.S. cardiologists place more than a half-million of these stents annually, so they are common. Not as common as #1 recyclable bottles, but common.

Remembering that the vast majority of Essure recipients, numbering 600,000 here in the U.S., have had no complications with device, the question remains: in some patients, could the localized inflammation caused by the Essure micro-insert be triggering a more generalized immune response?

It didn't seem to in some of the early studies done on Essure, where the device was placed in women who were planning on undergoing a hysterectomy for other reasons. Microscopic evaluation of the surgical specimens showed an acute and chronic inflammatory response that was confined to the area immediately adjacent to the Essure device, and did not extend outside the wall of the fallopian tube. But those findings were on very small numbers of patients evaluated in the short term, and who knows what happens over the longer, real-life timeframes of a permanent device like Essure?

So, Essure is coming up against a familiar predicament in medicine. Common side effects are common, and rare ones are rare; but then again, any drug or device can cause any reaction in any individual patient. And a side effect that shows up in, say, one of every 50,000 patients is unlikely to surface with the relatively small number of patients required for FDA approval studies. But it will when the drug or device hits the big time and the pharmacy shelves.

And from a regulation perspective, what number of potentially injured patients and what severity of injury (life-threatening is obvious, life-altering less so) warrants tighter FDA monitoring, or in some cases, removal of the drug or device? That's tricky.

A representative of the American College of Obstetrics and Gynecology told the FDA's expert panel that their organization planned on continuing to use the Essure device. A summary of the panel's discussion can be found here.

My advice? If you're in a long-term relationship and want permanent birth control, a vasectomy is THE choice. So simple. Easy access. Nothing to implant save a couple of sutures around the vas deferens. No general anesthesia as there is for a tubal ligation. Long track record, minimal risks. Easy, sure choice.

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