New concerns over controversial birth control device

This product image provided by Bayer Healthcare Pharmaceuticals, Inc. shows the birth control implant called Essure. Federal medical experts on Monday, Sept. 21, 2015 said it will take a closer look at a host of problems reported with Essure, including chronic pain, bleeding, headaches and allergic reactions. (Bayer Healthcare Pharmaceuticals, Inc. via AP)

RICHMOND, Va. (WRIC) — New concerns are surfacing regarding the controversial birth control device Essure.

WAVY affiliate WRIC has reported on women sharing stories of serious side effects and the FDA’s call for a black box warning. Now, WRIC has uncovered doctors are having trouble removing the device.

“I just wanted my life back that I had before,” says Khristi Gurganus, a Yorktown resident who suffered years with a bad rash and chronic pain after having Essure inserted. “I had sharp stabbing pain begin on my right side.”

The Bayer-made device, which consists of two nickel coils placed into the fallopian tubes to block pregnancy, was supposed to be permanent birth control. So when Gurganus found a doctor willing to take it out, she didn’t ask a lot of questions.

“I woke up from my removal surgery and immediately felt better,” Gurganus said.

Unfortunately, like others posting on the Essure problems Facebook page — which now has over 32,000 members — her relief after surgery was temporary.

Some women on the page reported needing two or three surgeries to completely remove the device.

“It can be a tricky device to remove,” admits Dr. Steven McCarus, a gynecological surgeon in Florida.

He has done about 90 successful Essure removals.  He recommends a minimally invasive hysterectomy but admits it’s complicated.

“You want to make sure that you have all device,” Dr. McCarus said.

A year ago, WRIC found sometimes the device can migrate in the body.

McCarus says imaging before surgery is critical.

“I have had patients in my experience that have Essure devices up by the liver, by the bowel,” McCarus explained. “It is almost like finding the needle in the haystack sometimes.”

It turns out in Gurganus’ case, her doctor used a surgical device called a power morcellator during her hysterectomy. It cuts up the tissue into smaller pieces and as a result metal fragments of the device were left behind.

“I do have this very acute pain on my right side and the rash still persists,” she said.

In a statement, Bayer stands behind the device.

“Bayer stands behind the positive benefit-risk profile of Essure, the safety and efficacy of which is supported by clinical trials, more than a decade of science and real world clinical experience. As FDA itself has stated recently, ‘Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.’ Every patient and clinical situation is different, and it is important that women speak with their doctor any time they have concerns or questions about this device.- Bayer Corporation”

However, the manufacturer does offer doctors guidance for removing Essure.

“I think the problem is doctors don’t look at it,” Dr. McCarus said.

Yet other doctors tell WRIC the lengthy instructions are vague and confusing.

As a result, a doctor in Texas has started his own Essure removals Facebook page. He tells us he hopes to educate other physicians.

There are success stories.

“I felt a thousand times better, I was alive again,” said Shannon Walsh about her Essure removal surgery.

When the rash, pain and brain fog became too much, costing the Hampton resident her job with the FBI, she did her homework. She then drove five hours to a doctor in Charlotte who was able to remove the device.

“I am so grateful I am alive,” Walsh added. “The takeaway lesson, do your own research.”

Gurganus and Dr. McCarus couldn’t agree more.

“Patients need to search, they really need to question their physicians,” says McCarus.

“What type of instruments will be used? It is really important to seek out a doctor who has experience in the Essure removal,” Gurganus added.

Questions Gurganus now wishes she had asked.

“To find out that I may deal with this the rest of my life, over a birth control choice,” a  teary–eyed Gurganus said.