You know it is a serious public health issue when famed consumer advocate Erin Brockovich is campaigning against a procedure that claims permanent contraception, but delivers excruciating pelvic pain and a variety of other side effects in women.

According to complaints emerging around the country, thousands of women are reporting that Essure, a medical procedure that provides permanent birth control for women, is also giving them unbearable cramps. One mother of two, Tanya Lovis described the pain as

literally walking around hunched over holding onto my stomach for three weeks out of the month…The pain was just too much to bear…Excruciating pelvic pain, sharp stabbing pains in my left and right side, I started bleeding very heavily and I would literally vomit from the spinning sensation…My body was telling me something was wrong…

The pain went away only after she underwent a radical hysterectomy, which included the removal of Essure coils. “Oh, I feel amazing. I feel like a new woman. I feel like they’ve replaced my body with another woman’s body,” added Lovis.

According to Bayer, the global pharmaceutical and chemical behemoth that owns the rights and trademark to Essure,

it is among the most effective permanent birth control available—even more effective than tying your tubes. Essure is hormone-free, surgery-free and there’s no slowing down to recover. You can get back to your family right away.

The official website for Essure makes it very clear that there are long term risks involved, including ectopic pregnancies and hives. Says the statement under the headline “Long-term Risks”

The Essure insert is made of materials that include a nickel-titanium alloy. Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching and hives.

The headline “Adverse Events” further adds:

During the procedure, the most common problem reported was mild to moderate pain (9.3%). Some of the women in the study reported moderate pain (12.9%) and/or cramping (29.6%) on the day of the procedure. A smaller percentage of women reported nausea/vomiting (10.8%) and vaginal bleeding (6.8%).

So although Bayer claims that women reported pain and cramping on the “day of the procedure,” the “long term Risks” or “Adverse Events” headlines do not warn against persistent or recurrent cramping months or years after the procedure is performed.

The Food and Drug Administration (FDA) accorded preemption status to Essure when it was approved in 2002, which insulates Bayer from potentially billions of dollars in lawsuits resulting from consumer complaints. In response to complaints, Bayer issued the following statement

“At Bayer, we care about patients and take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause. Essure was approved by the FDA in 2002, and has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effectiveness. Approximately 750,000 women worldwide rely upon the Essure procedure for permanent birth control. A recent practice bulletin issued by the American College of Obstetricians and Gynecologists (ACOG) has recognized that hysteroscopy tubal occlusion for sterilization has high efficacy and low procedure-related risk, cost, and resource requirements. No form of birth control is without risk or should be considered appropriate for every woman. It is important that women discuss the risks and benefits of any birth control option with their physicians.”

Brockovich is now trying to overturn the preemption status of Essure and drag Bayer into the courts. So will Essure continue to be offered at clinics around the country, and more importantly, is Essure even necessary?

China, the world’s most populous country, adopted hormone free intrauterine devices (IUDs) as the long term contraception method of choice, or sterilization as the permanent contraception to control its explosive population growth. Recently, Western women are increasingly giving natural methods based on cervical mucus or menstrual cycle a second look.

Whichever direction the Essure story takes, one thing is certain – there is still room for innovative medical device companies to come up with a safe, effective, side-effects and surgery free procedure for permanent contraception.

[image from Youtube]