Essure sterilization device continues to maim women: 500 new complaints last year
WASHINGTON, D.C., February 11, 2014 (LifeSiteNews.com) – Three months after famed consumer advocate Erin Brockovich sounded the alarm about the dangers of Essure, a sterilization device dubbed “permanent birth control,” women are still suffering crippling complications from the device.
Essure consists of two small metal coils inserted into a woman’s fallopian tubes, irritating them and producing a buildup of scar tissue that keeps eggs in the ovaries and blocks sperm from reaching them. Billed as a less invasive alternative to tubal ligation, the devices can be inserted during a regular doctor’s office visit, and unlike the pill, implants or the IUD, there are no hormones involved. The device does, however, slightly increase the risk of an ectopic, or “tubal” pregnancy, which always results in the death of the baby and can be life-threatening for the mother.
But ectopic pregnancy is not the only risk presented by Essure. A growing number of women have reported severe health problems after having the devices installed. Five hundred women reported complications to the FDA in 2013 alone, the largest number since the device was introduced in 2002.
On Facebook, a group called “Essure Problems” has more than 5,000 members, with 100 more joining every week. The group’s introductory page greets visitors: “Has life become a living hell since having the Essure procedure done? You are not alone.”
Group founder Angie Firmalo, 41, told the Chicago Tribune that she started the page two years after getting Essure – two years she spent suffering with heavy periods, joint pain, cramps and other symptoms. Ultimately, she discovered the coils had drifted out of her fallopian tubes and become embedded in her uterine wall.
“They sell Essure like a cruise, hand you a pamphlet like you're going on vacation,” Firmalino told the paper. But Firmalino is not alone in thinking her experience has been anything but a holiday. She says in just the last year, 435 members of her Facebook group reported having to get the supposedly permanent devices removed due to complications ranging from chronic pain to organ damage.
Because Essure is meant to be permanent, it is very difficult to remove after it has become embedded in a woman’s body, whether it is embedded in the correct location or not. That means many of the women who seek removal of their devices end up with a full hysterectomy, major surgery that has serious consequences on the lifelong health of a woman.
Firmalino told the Tribune that she first had her coils removed vaginally, but since then, X-rays have shown that there are still several “foreign bodies” in her uterus. She now plans to have a full hysterectomy. “I don't know if this will make it any better, but I'm debilitated by pain,” she said.
Rachel Long, 34, told ABC 57 in South Bend that she was sold on Essure because it was quick, easy, and covered by insurance.
“My husband and I had three children, I had terrible, terrible pregnancies,” Long said. “We love our children but we decided the Essure would be a permanent way to fix me.”
“We thought hey, for $50 deductible and no down time, hey why not?” said Long. “They made it sound like this miracle thing.”
But Long’s problems began within weeks of insertion, necessitating five trips to the emergency room in just three days and costing her family thousands.
“I felt like I was going to die, I felt like death,” Long said. “I had this deep, deep pain in my abdomen just two to three weeks after placement, anyone in their right mind would think this all started when this device was put into my body.” Eventually, she too had to have a full hysterectomy.
At least one death has been reported in relation to the use of Essure, according to a report by ABC 2 in Baltimore. A woman went to the emergency room with abdominal pain sometime after having the device installed, and was found to have a raging infection in her reproductive tract. Her cervix, fallopian tubes and uterus had all become necrotic, dead tissue. The infection ultimately killed her.
None of the women who have been negatively impacted by Essure are able to sue its manufacturer, Bayer, for damages. The device was granted “preemption status” upon its approval in 2002, which grants its maker immunity from lawsuits related to its use. This is a major reason Erin Brockovich has gotten involved – she wants to strip Essure of its preemption protection and allow women to seek compensation for their pain and suffering.
“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.”
Bayer, for its part, maintains that the benefits of the device outweigh any possible risks.
“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.
Still, the company has agreed to alter its literature to add chronic pain as a “rare side effect” and warn users that it is possible for the devices to “migrate” within the abdomen.
“We are saddened to hear of any serious health condition affecting a patient using one of our products, irrespective of the cause,” said the company. “No form of birth control is without risk or should be considered appropriate for every woman.”