ORLANDO – While some women report new-onset pelvic pain after placement of an Essure sterilization device, results of a retrospective study suggest this pain is actually associated with placement of the device in about 1% of cases.
Among 1,430 women who had an Essure micro-insert (Bayer) placed at a tertiary care hospital in Canada from June 2002 to June 2013, 62 secondary surgeries were performed, including some for removal of fallopian tubes and removal of the device.
In total, 27 patients reported new-onset pelvic pain after Essure placement and another 11 reported worsening of previous pain. Upon further workup, 15 of the 27 women in the new-onset pain group had another possible explanation for their pain, including surgical or pathology findings of endometriosis or adenomyosis. The investigators concluded there was a link between the pain and the device in just 12 (0.8%) of the women.
Among these dozen patients, the investigators linked the pain in eight women to perforation or migration of the Essure device. Investigators found no other obvious cause for the new-onset pain in the remaining four patients and attributed it to the Essure device.
Courtesy Bayer
Essure
Set realistic expectations, take a comprehensive pain history, and reassure women when they report post-Essure placement pain, James Robinson, MD, a minimally invasive gynecologic surgeon at Medstar Washington Hospital in Washington, D.C., advised at the meeting, which was sponsored by AAGL.
Dr. Robinson pointed out that there is no standardized approach to managing women with complaints of pain or guidelines on how best to remove the device. Imaging to confirm proper placement and to rule out other sources of pelvic pain, followed by medical or surgical management as warranted, can be effective strategies.
“There is less science here – it’s more the art of medicine, I think,” he said.
Dr. Robinson filled in as a presenter for one of the study coauthors, John A. Thiel, MD, of the University of Saskatchewan, Saskatoon, who was unable to attend the conference.
The study by Dr. Thiel and his colleagues suggests a thorough examination will typically reveal other reasons for pelvic pain and rules out the Essure device as the cause, Dr. Robinson said. The full findings of the study are published in the Journal of Minimally Invasive Gynecology (2016 Nov-Dec;23[7]:1158-1162).
Does removal help?
In a recently published case series of 29 women who had their Essure device removed laparoscopically because of pain, 23 reported relief following excision (Contraception. 2016 Aug;94[2]:190-2).
“Again, a subset had misplaced inserts or had another condition such as endometriosis,” Dr. Robinson said.
The majority of women whose pain resolved with removal of the devices reported their pain early on, so there is an important takeaway from this,” Dr. Robinson said. “We need to listen to our patients when they report pain shortly after device placement … and respond to that.”
Dr. Robinson advised physicians to be ready to surgically remove the device if that is warranted. “I think a lot of people doing these procedures are not comfortable taking their patient back to the operating room or don’t know who to send them to,” he said. “If you are going to place the device, you should be able to take it out or know someone who can.”
The bigger picture
Even though the Essure device is not frequently the cause of pelvic pain, physicians needs to be aware that some patients are likely to assume that it is.
Dr. Robinson pointed to a case in which a woman who had the Essure micro-insert placed 7 years earlier presented with a complaint of a bilateral tingling sensation over the course of 6 months. Online research led her to suspect Essure as the cause of her symptoms. However, on further investigation, it turned out she had relatively high levels of lead in her system from leaky pipes in her home. “It wasn’t an Essure issue,” he said. “But because it’s out there, people will jump to the conclusion that the foreign body is likely the cause of their problem.”
Ob.gyns. should become familiar with websites such as essureproblems.webs.com, which chronicle problems patients have reported with the device, he said.
When talking to patients, start with informed consent and listen to their concerns, Dr. Robinson advised. As part of the counseling about Essure permanent birth control, discuss the risks and benefits of alternatives, such as laparoscopic tubal ligation, long-acting reversible contraception, and vasectomy.
“I took the time to listen to the FDA hearing in Sept 2015 and … it moved me to listen to those patients, and I’ve been a huge advocate of Essure sterilization. I felt for a while I would never do another tubal ligation,” Dr. Robinson said. “But when you listen to patients who have real complaints, what sticks out in your mind is so many of these people are upset because no one took them seriously and listened to them.”