Two Missouri women, who claim the non-surgical sterilization device Essure caused painful and life-altering complications, have joined a grassroots online campaign led by activist Erin Brockovich to remove the device from the market.
It used to be that when a woman decided against having more children, the only permanent sterilization option was tubal ligation.
That changed when a non-surgical option, which is called Essure, became available nearly nine years ago.
In 2012, it seemed like the right solution for Jolene Fuller, a Pleasant Hill, MO, mother of four.
"We decided to go with Essure and have something where I wouldn't have the down time," Fuller said.
Essure is made up of tiny bendable coils that a doctor inserts into the Fallopian tubes during an office visit. The scar tissue that forms around the coils blocks the tubes from insemination.
Instead of the two-week recovery time she expected, Fuller says Essure led to a year of constant pain.
"My cramping started immediately after the procedure and never went away," Fuller said.
Along with cramping and bleeding, Fuller suffered bloating and swelling of the abdomen, which ironically made her appear pregnant. She says her symptoms robbed her of quality time with the family and sent her into a deep depression.
"I couldn't be the mother to my four children, I couldn't be a wife to my husband, and I lost me," Fuller said. "My oldest son would cry, ‘Mommy, I just want you healthy again so you can play with us.' And that's the hardest thing, knowing that you do something to make your family better and then come to find out that it wasn't the best choice and that you ruined a whole year that you can't take back."
Dr. Danielle Staecker, now working at the University of Kansas Medical Center, participated in the Essure clinical trials at Johns Hopkins University. In the 2 1/2 years of testing before Essure was approved, 745 women received the device. According to the FDA, 4 percent had the devices move, in some cases tearing reproductive organs.
"They are serious, but fortunately, uncommon side effects," Staecker said.
A sonogram taken a month after Fuller's implantation showed one of the coils had moved out of the Fallopian tube. A second sonogram nine months later revealed the device had become implanted in the uterine wall. The only way to remove it: a hysterectomy, the kind of major surgery Fuller had tried to avoid in the first place.
The surgery reversed all Fuller's symptoms and revealed she had a misshapen uterus; something that probably should have disqualified her from using the device. Essure packaging warns against the procedure in several circumstances, including "an unusual uterine shape."
"Do those women know about those conditions under which they shouldn't use this?" asked KCTV5 reporter Betsy Webster.
"Not necessarily." Staecker said. "That's why the healthcare provider has to do a very careful history asking about those specific things."
According to the FDA, Essure has been used in more than 750,000 women including Jeanie Esther. The Weston, MO, woman wishes she'd never heard of the device.
"Five days after implantation I had an ovarian cyst burst and since then I've had one burst every two weeks," Esther said.
Despite that timing, Esther says none of the 50 doctors that she has seen agrees with her belief that Essure caused her problems.
That's why she calls finding an Erin Brockovich website devoted to Essure issues her saving grace.
"I just started bawling," Esther said. "I'm going, 'I'm not the only one.'"
Brockovich is a consumer advocate and veteran of legal battles best known for the movie about her life that Julia Roberts won an Academy Award for.
When you Google the word "Essure," you will see Brockovich's site among the first page of results, where women can share their stories and concerns.
Brockovich spoke to KCTV5 via Skype about her reasons for launching the page.
"My story is being a voice for them because they are not being heard," Brockovich told KCTV5. "It's about awareness. I have had so many women who have written to us now and said, 'Thank you for the post. Thank you for sharing the stories. We didn't know about the situation. And now we feel we are better informed to possibly make a different decision.'"
Staecker is still recommending Essure to patients who've been properly screened as an alternative to the only other permanent option: tubal ligation.
"Between one and four per 100,000 women who get that procedure done will die on the operating table. There have been no deaths with Essure," Staecker said.
In the meantime, Staecker points out the best and safest way to prevent pregnancies involves no female parts at all.
"I think that when a couple is done with child-bearing, the man should consider a vasectomy: much lower complication risk and much lower pregnancy rate after a vasectomy."
Rosemarie Yancose, head of external communications for Bayer, the maker of Essure, issued the following statement to KCTV5:
"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 hysteroscopic 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."
Copyright 2013 KCTV (Meredith Corp.) All rights reserved.
Tuesday, July 22 2014 10:00 PM EDT2014-07-23 02:00:37 GMT
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