FDA’s Failure to Regulate Essure

September 30, 2015 — San Diego, CA.  At the September 24th FDA meeting regarding birth control device Essure, industry and gynecological advocates flocked in defense of the device. They assembled in the meeting to tell the FDA that Essure is “safe and effective” in the “vast majority of women.”

Similar to power morcellation cases, the medical industry relies in part on a certain device saying that “majority benefit,” “choice” and “convenient access” are terms which make it permissible to harm said majority.

During the panel, the American College and Obstetrics and Gynecology stated that Essure coils are a “safe and effective” means of birth control for women. ACOG suggested a registry to document the harm caused to these women so as to “better characterize” it. This is an extremely similar argument that ACOG used in the case of the power morcellator. Lastly, an issue was made very clear at the FDA meeting: the Essure device was not properly safety tested at the time of its approval.

Essure was approved in 2002 through PMA, or Pre-Market Approval. This means the product was put through what the FDA believes to be its most rigorous “safety testing” for medical devices. While these tests may be strict, it’s highlighted now that the FDA nor Bayer considered the Essure nickel-based coils.

Essure device

Nickel is one of the most common allergenic metals. When exposed to it, people can have allergic and hypersensitivity reactions. People are familiar with nickel allergies in earrings, watches, or belt buckles and the solution is usually to remove the allergic metal. However, removing Essure coils is not quite as simple as taking off a piece of jewelry.

When these coils are placed in the fallopian tubes, a severe inflammatory process begins. A woman’s immune system is strongly primed to respond to offending agents on mucosal surfaces to fend off infections and foreign bodies. In most women, this response leads to the scaring and blocking of the fallopian tube, which results in sterilization. Meanwhile, the nickel coil in Essure is not removed, leaving it in a sensitive area.

As a result, it shouldn’t come as a surprise that women who are completely healthy before getting Essure are reporting complications that are similar to inflammatory conditions where the immune system overloads, like lupus or rheumatoid arthritis. These symptoms include hair loss, rashes, joint pain, weight gain, swelling, blood clots, migraines and debilitating pain.

Removing Essure Nickel Coils:

Removing Essure nickel coils requires major abdominal surgeries, such as hysterectomies. It’s these largely invasive surgeries that Essure was created to avoid. The device’s label warns about pelvic pain, bleeding and allergic reactions shortly after the implant procedure, but how is it possible that neither Bayer nor the FDA provided information about the long-lasting inflammatory consequences with nickel?

A dermatologist was placed on the FDA’s expert panel at the request of patient advocates last week. Dr. Peter Schalock, a dermatologist at Massachusetts General Hospital in Boston, asked, “How can Bayer and the FDA have no knowledge of nickel allergies?” Schalock went on to ask several more hard-hitting questions such as, “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 Pre-Market Approval process doesn’t just presume a more thorough examination prior to introduction into the market, it also gives the device a special legal exemption status. If a device is PMA approved, the patient is stripped of her ability to sue the manufacturer for civil damages, which is a violation of their civil rights.

There may be some good news taken from this FDA meeting. Congressman Mike Fitzpatrick of Pennsylvania sent his medical advisor to the meeting, which reveals that he is on the side of medical ethics and women’s health.

The FDA only has one step to take next: immediately revoke Essure’s PMA status based on failed and incomplete safety testing in 2002. This would allow these women to sue Bayer, the manufacturer, and exercise their civil rights.

If you or someone you love is suffering side effects from the Essure Implant, contact our Essure lawyers today, click the banner below to access the Essure Claim Evaluation form.

Zofran form

Source: Philly