LOS ANGELES, November 8, 2013 (LifeSiteNews.com) – Erin Brockovich, the famed law-clerk-turned-consumer advocate who took on Pacific Gas and Electric in the 1990s and was subsequently played by Julia Roberts in a feature film bearing her name, has a new target: the makers of the Essure sterilization device, which Brockovich says is unsafe.
Essure is a small metal coil designed to be inserted into a woman’s fallopian tubes. The device irritates the tubes and causes scar tissue to form, which blocks the fallopian tubes, preventing fertilization.
Typically performed as an outpatient procedure, Essure is billed as a convenient, less invasive alternative to tubal ligation for those seeking permanent sterilization.
But Brockovich says the device is unsafe. Citing nearly 1,000 reports filed with the FDA about adverse complications including excessive bleeding, perforated organs, chronic pain, and other injuries resulting in emergency hysterectomies and at least one death, Brockovich has launched a website and petition for women to come forward with their own horror stories.
“There's something wrong with the device, in my opinion,” Brockovich told ABC News. “It's a form of permanent birth control, and women's organs are being perforated … It's ridiculous that at any level we try to defend this.”
“If 30 women did suffer harm for unknown reason, we'd investigate,” she said. “We have thousands injured. I don't think it's safe.”
Brockovich wants Essure’s manufacturer, Bayer, to take the device off the market and launch a full investigation into its safety.
She also wants the government to allow women to sue Bayer for their suffering. She says Essure is just one example of the problems with “preemption laws,” which block consumers from suing manufacturers of certain products the FDA has approved. The Essure device is one of those products, having been granted preemption status when it was approved in 2002.
“Preemption is not about the Essure women – it affects all consumers,” Brockovich told ABC. “If someone had a medical device installed, there's no recourse for victims, and the company is protected. If there's a problem, the company gets a pass, because they have preemption. It dawned on me the consumer didn't know. The women didn't know that this existed.”
The petition on Brockovich’s website demands the government revoke the device’s protected status.
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The stakes could be high for Bayer if Essure’s preemption protection is removed. The damages caused to women by the device can be crippling.
“From the minute I got it, I woke up in excruciating pain,” Melanie Goshgarian, of Burlington, Massachusetts told WGGB-TV. “I had heavy bleeding, I couldn’t get out of bed for four days. And they just kept telling me it would resolve itself and my body is just getting used to it.”
Afterward, she developed a debilitating allergy to nickel, the metal from which the device is made.
“Just getting dressed — it’s shoes, it’s pants, it’s clothes, it’s everything that touches you — even opening the door, like I have all the doors open in my house,” Goshgarian said. “I come home and I think about ‘How am I going to open my front door today?’ because that’s going to make me itchy for a half-hour. Keys, just even paying at a parking garage when I was waiting for my turn, I had a quarter in my hand, I felt a pain in my neck and my back and I’m like, what is going on now?”
Another victim, Jessica LaVallie, told the station, “Less than 24 hours after the insertion, I was back in the hospital and I was in the hospital for five days with an infection.”
For the next two years, LaVallie suffered pain, fatigue, memory loss, migraines, and horrible bloating that, ironically, left her looking pregnant even though the whole point of the device was to block pregnancies.
“It’s just been pure Hell the past two years, really,” LaVallie said. To remove the device, she had to have a partial hysterectomy.
Maria Larsen, also of Massachusetts, told WGGB she had to have major surgery to save her organs after implanting the device.
“I had scar tissue built up that tethered and pulled and attached my organs all together, so my bladder and my uterus and my abdomen were all kind of attached and had to be cut apart,” she said.
Dr. Jennifer Ashton, a senior health contributor for ABC News, says she refuses to offer Essure to her patients because of the risks involved.
“Whenever there is the permanent placement of a foreign body – in this case, metal coils – inside the body, there is the potential for chronic pain,” Ashton told ABC.
But Bayer insists the device is safe for women. “Essure…has a well-documented benefit-risk profile, with over 400 peer-reviewed publications and abstracts supporting Essure’s safety, efficacy and cost-effectiveness,” the company said in a statement.
“We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause,” the company said, adding, “No form of birth control is without risk or should be considered appropriate for every woman.”