by JOCE STERMAN, Circa | Monday, November 26th 2018
WASHINGTON (Circa) — A Circa investigation uncovered unsettling complications related to a popular birth control implant that’s designed to prevent pregnancy for years. Nexplanon, a matchstick-sized implant, is placed in a woman’s body and releases hormones that keep her from getting pregnant. But Circa discovered the product has the potential to migrate or move. And in some women, the implant has ended up in dangerous places including their lungs, chest and vital arteries.Popular birth control implant
Tenayah Dawson is a mother of three. After her last son was born, she wanted lasting birth control and opted for Nexplanon. But just two months after getting the implant placed in her arm, she could no longer feel it. Medical records show two doctors tried to locate and remove it but were unable, eventually sending her for an MRI.
“I was angry,” Dawson explained. “I was like, what do you mean it moved? I was really concerned. It moved? How can it move?”
The device, according to Dawson’s medical records, had migrated from where it was placed. On a third attempt, captured by a family member on video, the implant was successfully located and removed. But not until after what Dawson described as a fishing expedition that lasted almost 90 minutes.
“She was just digging, digging, digging,” Dawson said. “She was fishing for a long time.”
Nexplanon is a popular device. It gets plenty of women talking on the internet, sharing their experiences on YouTube. Vlogger Emily Freybler detailed her experience of getting the implant online, saying, “They put this little rod that’s flexible into your arm. And it distributes hormones, so you don’t get pregnant basically.”
Destiny Jay told her followers, “It just stays in your arm and it stays three years. I was like, wow that seems easy.” And Bridgette Berena videotaped her physician placing the implant in her arm so people could see the process.
We asked George Washington University Hospital physician Dr. Jennifer Lesko, an OB-GYN and associate professor, about the implant. She told Circa she places an average of three Nexplanon a week, saying, “It’s really reliable birth control. If you don’t want to be pregnant. This is one of the best options out there. It’s considered extremely safe.”
But as with any birth control, there are risks. With Nexplanon, migration or movement, is one of them. It can be concerning, as it was with Tenayah Dawson. Or downright dangerous if the implant moves to the lungs, chest or arteries. Though it’s hard to gauge exactly how often this happens, there’s history when it comes to migration with this type of birth control implant.
Nexplanon is a newer version of a product called Implanon, which had its problems with migration. In one ongoing lawsuit, women claim the Implanon implant spontaneously moved and couldn’t be found or removed. But Merck, which now sells the implant, made significant changes to the product and Nexplanon was born. Dr. Diana Zuckerman with the nonprofit National Center for Health Research explained, “The product was revised and it was made radio-opaque so that you could find it on X-ray and so that way if it did migrate, it would be easier to find.”
A Circa investigation found migration is still a problem with Nexplanon. We looked through thousands of “adverse reports” filed with the Food and Drug Administration about Nexplanon in the last six years. We found at least 400 reports indicating movement, which was classified as “device dislocation.” More than 100 reports were listed in the FDA system as “serious,” and a small number had what was listed as life-threatening complications, hospitalized or disabilities. The FDA told Circa some of its reports in the publicly available database could be duplicated and that it has not confirmed them.
Medical journals do document some extreme cases where the Nexplanon implant traveled to a woman’s lungs and even major arteries. One report Circa found came from the FDA itself. It details 20 previously unpublished severe Nexplanon cases through 2015, including women who needed surgery in an operating room to pull the implant after it migrated. The FDA researchers from the Division of Pharmacovigilance also found cases where doctors just couldn’t find the implant to take it out. Zuckerman said, “The fact that they did write an article about it suggests to me that people there thought this was an issue that could be dangerous and they wanted to make sure people knew about it.”
Zuckerman has spent decades researching health and safety issues. She says there are likely more cases the FDA is unaware of given that reporting to the agency is voluntary for health care practitioners and the patients themselves.
“Remember this is the tip of the iceberg,” Zuckerman said. “Most problems like that aren’t going to be reported. If you’ve got a couple of hundred, most likely that means there’s a few thousand at least.”
In a statement to Circa, a Merck representative said, “Merck is committed to providing women with safe and efficacious birth control options, including Nexplanon. Nothing is more important to Merck than the safety of our medicines and the people who use them.”
The company indicated it vigilantly monitors the voluntary reports filed with the FDA. But the company wouldn’t agree to an on-camera interview or answer specific questions about Nexplanon. But we know they changed the product’s label in 2016, adding in new language to better warn about the possibility that the implant may migrate. A letter was also sent to health care practitioners to make them aware.
Still, women experience complications. A picture from a young woman in California who documented the aftermath of her removal went viral on social media with thousands of shares. And while some sing the implant’s praises on YouTube, others have detailed their difficulties. Lexi Arp is among them. She had Nexplanon implanted soon after having her daughter. Arp’s trouble came when she tried to have Nexplanon removed shortly after implantation when she couldn’t locate it. She told CIRCA she didn’t get a warning about the potential for difficult removals, migration or other complications.
After visiting a physician and the emergency room, records show doctors eventually found the implant near her underarm. Arp was forced to undergo surgery to have it removed.
“He also thought it would be a super quick, easy procedure,” Arp explained. “So 15 minutes pass, he can’t find it. 20 minutes. 30 minutes. He can’t find it. So finally he’s like, I think I need to make the incision bigger.”
But doctors like Jennifer Lesko say complications are rare. In her 11 years of experience, Lesko said she’s never had trouble removing the implant and will continue to stand by Nexplanon as a reliable, safe birth control option for women.
“I think this device is very safe. And I think that it’s a very effective method of birth control. And I think that these sort of rare consequences, are extremely, extremely, extremely rare in the grand scheme of things and I don’t think that should deter anyone,” she said.
Tenayah Dawson was deterred. Although she said she’s done with having children, she’s not willing to give the implant another try.
“I don’t think that this is a side effect anybody should have to deal with. If it’s an object and it’s put there, it should stay there,” she said.