Essure: Another FDA failure to regulate

On Sept. 24, the Food and Drug Administration held a hearing on the Essure sterilization coil,  used to achieve permanent birth control for women.

Hundreds of thousands of young and otherwise healthy women across the world have received Essure coils since 2002. However, over the subsequent decade thousands of severe adverse reactions to the coils have been reported.

This past week, industry and gynecological advocates, in defense of Essure, assured the members of the panel assembled at the FDA that it is "safe and effective" in the "vast majority of women".

So, just as with the power morcellation case, we have an industry whose livelihood depends in part on a certain device saying that "majority benefit", "choice" and "convenient access" are terms which make it permissible to harm a minority.   

We felt compelled to attend the FDA hearing on Essure. You can watch our testimonies here and here.

You can read about the power morcellator disaster in women's health here.

During the Essure hearing, the American College and Obstetrics and Gynecology (ACOG) highlighted that Essure coils are a "safe and effective" means of birth control for women.  ACOG called for a "registry" to document the harm being caused to these women so as to "better characterize" it.   This argument was the same one that ACOG used in the case of the power morcellators, as you can see here.

Another issue became abundantly clear at the FDA hearing: Essure was not adequately safety tested at the time of its approval.

The Essure coils were approved in 2002 for use in women through an FDA process known as "Pre-Market Approval" (PMA). This means that the product was put through what the FDA considers its most rigorous "safety testing" for medical devices.

But what became very clear at the FDA was that neither Bayer (as the maker of the Essure coils), nor the FDA had considered that the Essure coils contain nickel.

Nickel is one of the most common allergenic metals.  What that means is that many people, when exposed to it, will have allergic and hypersensitivity reactions.  Many people are familiar with nickel allergies in earrings, watch bands, belt buckles etc.  The solution for people who have reaction to nickel is removal of the offending metal.  But taking out Essure coils is not as simple as taking off a piece of jewelry.

When these nickel coils are placed in women's fallopian tubes, an intense inflammatory process is started.  The immune system is very strongly primed to respond to offending agents on mucosal surfaces to fend off infections and foreign bodies – and the Fallopian tubes in women are a mucosal surface.

In most women, this inflammatory response leads to a scarring and blocking of the Fallopian tube, resulting in sterilization in most women.

The Essure nickel is not removed, leaving it in an immunologically sensitive area.

We believe it should be no surprise then, that women, who were completely healthy before getting Essure, are reporting crippling systemic complications that appear very similar to inflammatory conditions which the immune system goes haywire, like lupus or rheumatoid arthritis  -- hair loss, rashes, joint pain, weight gain, anemia, swelling, blood clots, migraines, unexplained, debilitating pain.

Removing the Essure coils requires major abdominal surgeries, such as hysterectomies.

Essure's label warns about pelvic pain, bleeding and allergic reactions shortly after the implant procedure, but how could neither Bayer nor the FDA anticipate long-lasting inflammatory consequences?

At the request of patient advocates a respected dermatologist was placed on the FDA's expert panel on Essure last week. Dr. Peter Schalock is a dermatologist at Massachusetts General Hospital in Boston. "How can Bayer and the FDA have no knowledge of nickel allergies?'' he asked. "Where did you test these people? How did you test these people? What did you test them with? Are we just making this up just for fun or is there data?"

The PMA process does more than just presume a more thorough examination prior to entrance into the market, it also gives the device a special legal exemption status. If a medical device is PMA approved, the patient is stripped of her ability to sue the manufacturer for civil damages, a serious violation of their civil rights.

There was a silver lining at last week's hearing. Congressman Mike Fitzpatrick of Pennsylvania sent his senior medical advisor to the meeting, indicating that as with the morcellator case, he is standing on the side of medical ethics and women's health.

The FDA leadership has only one cogent action to take and that is to immediately revoke Essure's PMA status based on its unacceptably incomplete safety profiling in 2002. This action, at the very least, would allow these women to exercise their civil rights by taking their grievances to court.

We know that congress now sees her charge to protect minority subsets of American citizens.  Here again is just another example of individuals being harm by "benefit of the majority", "choice", "convenience", and corporate and federal ethics - gone rogue.

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