MINNEAPOLIS (WCCO) — Women are planning protests across the country this week against a form of permanent birth control.
The FDA announced it will take another look at Essure, the device marketed as being safer and cheaper alternative to getting your tubes tied.
It is a non-invasive, in-office procedure approved in 2002 with no down time. But some Minnesota mothers want to warn others about their experience.
Nettie Knotz feels her life is full with her family of five.
“Our little Carol, we actually didn’t know we were pregnant with her until we gave birth to her,” Knotz said.
It was then she and her husband knew it was time for permanent birth control.
“It seemed like Essure was the best thing and our medical insurance would pay for it,” Knotz said.
Essure is the only non-surgical sterilization available for women. The patient video shows it works by placing a micro coil into a woman’s Fallopian tubes. Scar tissue builds around it to form a natural barrier to prevent pregnancy.
Soon after having the procedure in 2011, Nettie said she began cramping, had increased headaches, pain and often felt fatigued — frequently having to take breaks while playing with her kids.
The manufacturer, Bayer Healthcare, reports Essure coils have been placed in 750,000 women worldwide. In less than one-percent of patients, the insert produces symptoms they say does not go away.
“It doesn’t affect just us women, it affects our families,” Knotz said.
The Food and Drug Administration approved Essure in 2002 after two and a half years of clinical trials. It went through the FDA’s most rigorous testing, and because of that, women cannot sue over complications.
The FDA has updated risks and reported problems on its website. To date, nearly 5,093 reports have been filed. The majority of the complaints — 3,353 of them — were some type of pain.
Dr. Edio Zampaglione is Bayer Healthcare’s vice president of U.S. medical affairs.
“First and foremost, you know, we sympathize with them. We are not happy about the fact that they have not had good experiences with our product,” Zampaglione said.
He says there are no plans to take Essure off the market, and adds the risks associated with the product are known and expected.
“We stand behind Essure. The data consistently shows that Essure, the benefits outweigh the risks with the procedure,” Zampaglione said.
Dr. James Presthus of Minnesota Gynecology and Surgery began implanting Essure soon after its approval.
“It sounded like it was going to be great. And for the majority of patients I think it is, but like with anything we do with medicine, there are some patients that have problems,” Presthus said.
He is now admittedly more cautious when offering Essure, and more often offers women an alternative to living with the pain by removing the Essure coils.
“For a lot of patients they were told their only recourse was to do a hysterectomy. I was able to offer patients the opportunity to do this with a less invasive way that didn’t remove the uterus,” Presthus said.
He believes the issue has reached what he calls a critical mass.
“The problem right now, I think we’re seeing the tip of the iceberg,” Presthus said.
Shawn Mosch experienced debilitating back pain, a low libido and low energy after her Essure procedure in 2009.
“My daughter plays hockey, which I love to go to, so there were times that I was like, ‘I don’t even want to go,’ because sitting in those stands was just, I just want to curl up and cry,” Mosch said.
She realized what the problem was after connecting with thousands of women like her on Facebook, and she discovered an ally in Erin Brockovich. The well-known consumer advocate offers women a forum to share their symptoms and frustration.
Mosch’s pain remedy: a hysterectomy in March.
“But it still was just a mentally emotional thing to say I’m losing that part of my body and it’s gone and I have to deal with a major surgery to fix a procedure that was supposed to make everything better,” Mosch said.
She realizes she can never get the last six years of her life back. And she looks forward to spending time with her family again.
“I am three months post-op now. Absolutely no back pain,” Mosch said.
The FDA will hold a public meeting in September to discuss Essure’s safety and effectiveness. Medical professionals, patients and the public are invited.
Since there is no legal recourse, the women hope their stories will help others and convince the FDA to take Essure off the market.
Click here to read the complete statement on Essure from Bayer Healthcare.