RICHMOND, Va. (WRIC) — More complaints have been uncovered linked to the birth control device Essure including reports of the device breaking into pieces inside the body.
The device consists of two nickel coils inserted into the fallopian tubes to block conception. Thousands of women have urged the Food and Drug Administration to pull it from the market and a decision is expected Monday.
“A lot of times they are completely unraveled,” explains Holly Ennis.
“It’s perforating the uterus.” — Holly Ennis
Ennis represents 200 women in every state reporting complaints with Essure.
She’s been talking closely with doctors who have removed the device for women and found in many cases of the coils stretched and moved from the fallopian tubes.
Ennis shared some photos of what doctors found, “it’s perforating the uterus,” she says.
Among Ennis clients Mechanicsville mom Lacy Bradley.
“Really, I want my life back,” says Bradley.
Bradley first shared her painful experience last year.
“Teeth started breaking, I started noticing really bad jaw pain.” — Lucy Bradley
“I woke up in the middle of the night covered head to toe in hives,” she told us.
She had the device implanted after she and her husband decided four kids was enough. Soon after, her hair started falling out, she suffered severe bloating and an allergic reaction to the nickel. Since 8News last spoke to Bradley, things have gotten worse.
“Teeth started breaking, I started noticing really bad jaw pain,” Bradley explains.
Bradley had to have a tooth had to be removed.
Even scarier, the device appears to be breaking apart inside her body.
“Unfortunately in the last six months, I have passed particles or pieces of Essure,” says Bradley.
It’s all similar to what Ennis is hearing from her other clients.
“There are some really, really significant injuries, life altering,” Ennis explained.
8News has uncovered more than 5,000 complaints to the FDA about the device including reports of death.
Just recently a Congressman alleged the FDA may have underestimated the number of fetal deaths associated with Essure saying his data experts find the number not to be five but more like 300.
A Facebook page posting about Essure problems from women calling themselves “E-sisters”, now has more than 27,000 members.
More than 5,000 complaints have been uncovered to the FDA about the device including reports of death.
“We feel that there is no way that this device can be made completely safe with every woman, you’re sort of playing Russian roulette to figure out which woman it is going to be safe for,” said Ennis.
Bayer, the makers of Essure, stand by the product saying hundreds of thousands of women have had success with Essure:
“The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-surgical procedure, is supported by more than a decade of science, as well as real world clinical experience, with the product studied with more than 10,000 women since Essure was first developed.”
The good news for Bradley, she’s finally found a doctor willing to remove the device but it will mean a hysterectomy.
“It is a big life changing event,” said Bradley.
The FDA says the concerns are a high priority and it is reviewing all sources of information and studies. For women like Bradley, there’s only one option.
“I want them to take it off the market,” states Bradley.