(WGGB) — It’s a permanent form of birth control, marketed as a “surgery free way” to prevent unplanned pregnancy.
The makers of Essure — Bayer, Inc. — say their product has a 99 percent success rate, but some local women argue Essure is not only ineffective, but it’s dangerous.
“From the minute I got it, I woke up in excruciating pain, 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,” says Melanie Goshgarian of Burlington.
“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,” adds Maria Larsen of Holliston.
“It’s just been pure hell the past two years, really,” says Jessica LaVallie of Palmer.
For three Massachusetts mothers who were finished having kids, Essure seemed too good to be true — an easy, in-office procedure where doctors insert small coils into the Fallopian tubes, creating scar tissue and permanently preventing pregnancy without a hysterectomy.
“I was given a brochure, it just seemed like a vacation package — in a couple hours you’ll be fixed and you won’t have to think about this for the rest of your life,” says Goshgarian.
However, LaVallie says her experience was quite the opposite.
“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,” she says.
Over the next two years, LaVallie says those two small coils took over her life — incredible pain and fatigue, memory loss, blinding pain from migraines, and bloating so severe she often looked pregnant.
All three women say they encountered skepticism from doctors, who were unsure their symptoms were connected to Essure. It wasn’t until they went online and found a Facebook group with thousands of women describing similar symptoms that they finally found some answers.
“It’s just not me, this one person in Palmer who has this issue,” says LaVallie. “It’s this huge global thing that’s happening.”
She adds, “We’re just trying to make awareness, that’s our goal.”
Now, famed attorney Erin Brokovich is leading the charge, creating an online petition to get Essure off the market. On her website, many women express concern about the components of the coils — materials like pet fibers and nickle.
“If you do a skin test for nickel, it’s not the same as having nickel in your body and you know, when your body fluids are touching these things, they change,” says Larsen.
Goshgarian wasn’t allergic to nickel when she had the device implanted. Now, five years later, she’s allergic to metal.
“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. 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,” says Goshgarian. “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?”
ABC40 reached out to several local doctors who implant the device. They say they’re happy with the product. However, they declined to go on-camera.
There are hundreds of doctors and patients who have filed adverse event reports with the FDA.
For most women, a hysterectomy to remove the coils is only way to reverse their symptoms.
Goshgarian says she’s spent at least $20,000 on doctors visits and surgeries this year alone, but the coils are out of their body and that’s something all three women agree is worth every penny.
“I just had my partial hysterectomy a month ago and, honestly, I’m starting to feel like me again and it’s been a very long time,” says LaVallie.
Many insurance companies cover the cost of having Essure implanted, but they don’t always cover the cost of a follow-up visit where doctors check to make sure the device was implanted properly.
Goshgarian tells us she received a $3,500 bill for her follow-up visit, but some women can’t afford that.
The makers of Essure say those women aren’t following the FDA approved 5-year instructions for use, so their subsequent side effects, coil perforations and pregnancies aren’t taken into account when the company claims Essure is 99 percent effective.
ABC40 reached out to the company that makes Essure — Bayer, Inc. — and asked them to respond to complaints about their product’s safety.
Bayer tells us: “We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause…The FDA found that ‘Although there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known.’”
Right now, consumers cannot sue Bayer, Inc. because Essure is classified as a Class Three Device by the FDA, barring anyone from filing a lawsuit against the manufacturer.
Erin Brokovich is currently working to rescind that classification with an online petition, which currently has more than 5,000 signatures.