For many, 5-minute fix is anything but…
byMedPage Today Staff
Tanya Perry was looking for relief from heavy bleeding during her period when her ob/gyn suggested endometrial ablation with the NovaSure device in May 2017.
Her doctor told her it would be a quick and easy procedure, and she’d be able to go home the same day. The thin device would be inserted through her cervix into her uterus, and it would burn away her endometrial lining using radiofrequency (RF) energy. Less endometrium would mean less bleeding.
She also thought it would be less risky than a hysterectomy, a major surgery, she said.
“I was leery, but I trusted my doctor,” the 44-year-old mother of two kids, from Buffalo, New York, told MedPage Today.
Endometrial Ablation: Be Warned
The quick procedure, done right in her ob/gyn’s office, went fine, but within six months Perry developed severe pain that recurred in a cyclic pattern. It was so intense — as wrenching as being in labor, she said — that she had to take a lot of time off from the teaching job she had at the time.
She felt that her ob/gyn wasn’t taking her pain seriously, so she searched for another specialist. That doctor ultimately diagnosed her with an “endometrial ablation failure” after observing pockets of blood building up behind extensive scar tissue resulting from the procedure.
Perry’s treatment: a hysterectomy, the procedure she thought she’d avoid with endometrial ablation and NovaSure.
Since her uterus was removed in September 2019, Perry said she’s feeling much better and is able to get back to work as a teacher’s aide and enjoy time with her two kids, now ages 14 and 16.
“It’s just a sin that I had to go through that,” she said. “I hope no woman has to go through this again.”
Women interviewed by MedPage Today said they were pitched endometrial ablation as a simple, easy procedure with few risks to relieve their heavy menstrual bleeding. Yet like any surgery it can carry complications, and there are limited data on rates of ablation “failures” like Perry’s — such as bleeding heavier than before, severe labor-like cyclic pain, and subsequent hysterectomy.
Moreover, scarring from the procedure may obscure uterine tumors, delaying diagnosis and potentially worsening the prognosis.
Thousands of women in the U.S. and around the world are taking to Facebook groups and online petitions saying their ablation led to serious issues, and trying to warn others about their experience.
The most active Facebook group has more than 5,000 members, and a petition to pursue a class action lawsuit has nearly 1,700 signatures, with names still being added. Individual lawsuits have already been filed and product liability attorneys are advertising for clients.
These women share stories of crippling pain, hemorrhaging on operating room tables, having bowel surgeries and hysterectomies, and becoming violently ill with sepsis. They also lament economic losses from missed work due to complications, and the damaging impact ablation had on their relationships and their sex lives.
A MedPage Today search of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database over the last 11 years for the most frequently used endometrial ablation device — NovaSure, made by Hologic — turned up hundreds of reports documenting serious harm: severe sepsis, bowel surgeries, hysterectomies, burns, perforations, and other events — including fatalities.
While the procedure may be safe and effective for many of the women who undergo it, sparing them from hysterectomy, the lack of good data on complications and failures is keeping women from a clear picture of their risks, experts told MedPage Today.
“Word is getting out that there’s a significant failure rate for ablations,” said Arthur McCausland, MD, a retired ob/gyn in Sacramento, California, who was one of the first physicians in the country to report on a specific type of endometrial ablation failure called post-ablation tubal sterilization syndrome, or PATSS.
“These long-term complications can happen, and patients really need to be informed of this before they make a decision about what’s best for them,” McCausland said.
A Five-Minute Fix
In its email marketing, Hologic describes NovaSure as a “one-time, five-minute procedure for heavy menstrual bleeding.” Its radiofrequency tip is referred to as a “slender wand” with netting that expands to the size and shape of each uterus.
The RF energy delivered by that “wand” is “precisely measured” and only blasts away endometrium for about 90 seconds, the email says. Ultimately, the procedure should “lighten or end your heavy periods,” according to a patient brochure.
NovaSure and its competitors represented a considerable improvement over earlier incarnations of endometrial ablation. In the early 1990s, ob/gyns were using a hysteroscope — a device with a steep learning curve to operate — to continually look inside the uterus as they burned away tissue with either a rollerball or cutting-loop electrode.
But a handful of deaths due to hyponatremic encephalopathy were reported in the medical literature. The fluids used to open up the uterine cavity during hysteroscopy were being absorbed into the bloodstream, causing fluid overload, hyponatremia, and brain swelling. So the quest for safer approaches began.
“Second-generation” or “global” endometrial ablation devices hit the market in the late 1990s, with five approved from 1997 to 2003: Thermachoice (by Johnson & Johnson/Ethicon); Her Option (Cooper Surgical); Genesys Hydrothermal Ablation or HTA (Boston Scientific); NovaSure (Hologic) and the MEA System (Microsulis).
Though the technology for eradicating endometrium varied — from radiofrequency to microwave to steam to cryotherapy — none required a hysteroscope, and all could be done in an office under local or general anesthesia, which meant that more ob/gyns were able to perform them.
However, only two of those devices — NovaSure and Genesys — remain on the market. Others have been introduced in recent years, including Minerva, but have a smaller proportion of the endometrial ablation market share.
The idea of skipping a major surgery like hysterectomy, in favor of a “minimally invasive” procedure, is appealing. Studies have indicated that endometrial ablation is generally safe and works as it’s supposed to for most women.
But women interviewed by MedPage Today said they didn’t get a good sense of the potential risks when they were told about endometrial ablation as an option. They may have signed consent forms, but they didn’t have a satisfactory discussion of the surgical risks, and no one talked to them about what could happen if their procedure failed.
Five days after Brianne Mayercsik, 34, had an endometrial ablation with NovaSure in December 2013, she was standing at the printer at work when she felt something “pop” inside her.
Then the pain hit. She went home, took some pain medications, and tried to relax, hoping it would go away. By late afternoon the pain had only gotten worse, so she drove herself to the emergency department.
Even the stronger meds given in the ED weren’t helping, and she started to vomit. A sonogram suggested something was amiss, but access to the MRI suite wasn’t available until the following morning.
When the MRI results finally came back, they showed perforations in her uterus and her bowels. The contents of her bowels were leaking into her abdomen.
Mayercsik, who lives in suburban Raleigh, North Carolina, needed emergency surgery to remove her uterus and resect four inches of her small intestine.
Her ob/gyn inspected her uterus after it was removed and told her it was heart-shaped, rather than rounded at the top. That kind of anatomy may have disqualified her from the procedure, but it hadn’t been detected on earlier tests.
“I’ve had C-sections with two kids, so it was kind of a shock to find out that no one knew the shape of my uterus until it was removed,” she said.
“That was one of the most traumatic and painful experiences I’ve ever been through,” Mayercsik said. “It was just shocking and traumatic, and I don’t want anyone to have to go through that.”
“If you’re done having kids, just talk to your doctor about getting a hysterectomy,” she said.
Stories like Brianne’s should be relatively rare, yet it’s hard to know their exact rates, as no post-marketing study has captured how often these complications occur with real-world use of endometrial ablation devices.
MedPage Today’s search of the FDA’s MAUDE database for the Novasure device, the device used in some 60% of the roughly 500,000 endometrial ablations performed each year in the U.S., turned up hundreds of reports of complications from 2009 through 2019.
Among them were reports of six deaths. Four were from sepsis, the result of perforations to the uterus or bowel that led to infections that spread through the body. One of the deaths was due to cardiac arrest during the procedure, potentially a complication of anesthesia. The sixth resulted from pulmonary embolism the night after the procedure.
Jill Long, MD, MPH, a public health researcher who previously worked for the FDA, published an analysis of MAUDE reports for endometrial ablation devices from 2005 through 2011. She found four deaths during that time period. (Long’s current employer asked not to be named, as a condition of allowing her to speak on this topic to MedPage Today.)
“It wasn’t shocking that there could be deaths, but I think it was worth reporting and being aware that is a potential complication of these procedures,” especially given that this is “a minimally invasive procedure that’s considered pretty minor,” Long told MedPage Today.
MedPage’s 11-year MAUDE analysis revealed hundreds of serious complications ranging from perforations and burns to follow-up revision/repair surgeries.
One limitation of MAUDE data is that complication rates are “hard to know because we don’t have good denominator data on how many of these procedures are done,” Long cautioned.
It’s well known, however, that the MAUDE database is underreported, she said.
Hologic estimates that three million NovaSure procedures have been done worldwide since the device came on the market nearly 20 years ago.
Even if that suggests a low risk of complications, it does raise questions about the acceptable risk in a relatively young and healthy population whose chief complaint is heavy periods.
A Hologic media representative provided an emailed statement in response to a MedPage Today query about the adverse events: “Hologic maintains post-market quality assurance tracking of all reportable events through its representatives and by direct communications with healthcare providers.”
“Potential adverse events are clearly stated in the FDA-approved labeling including the NovaSure health provider Instructions for Use (IFU). As it relates to adverse events reported, these events are rare and consistent with those presented in the IFU.”
All of the events, including death, are listed in the IFU under a section called “other adverse events.”
“Hologic estimates when factoring in the number of devices shipped, the rate of thermal bowel injury after NovaSure endometrial ablation is remarkably low, and to be less than 1 in 10,000 cases.”
Shelly Kuehlem, 42, who lives in suburban Chicago, said she probably wouldn’t have had NovaSure if she was better informed about the potential risks. She still gets anxious and tearful when she recalls her experience.
“The doctor made it seem very risk-free, that it would be an in-and-out type of thing,” Kuehlem told MedPage Today.
It was April 2015 and at first, everything was fine. She had no pain from the procedure and she was feeling good the next morning, a Saturday.
“Then it just hit me like a ton of bricks, like I got the flu,” she said. “It was immediate.”
Her husband, shocked by the quick change in his wife’s health, rushed her to a nearby emergency department, where doctors told her she had only a mild infection. They gave her medication and sent her home.
By Monday, she was “throwing up profusely, and I had this pain that just kept crawling up my body.”
She went back to the emergency department where they did imaging and eventually diagnosed her with sepsis. She would need emergency surgery to “clear the murky fluids out of your body,” she remembers being told.
“They said, ‘don’t freak out, you might wake up with a tube down your throat, we might need to do a bowel resection, we have no idea what we’re walking into,'” she recalls.
The cause of her infection: two perforations in her uterus from the endometrial ablation. She didn’t need a hysterectomy or bowel repair at that point, but she says the experience was “very intense and scary.”
Kuehlem says she now has very intense cramps, worse than she ever had before, and her new ob/gyn told her she will need a hysterectomy.
“I just feel I don’t have time for a hysterectomy, nor do I have anyone to take care of my kids during recovery,” Kuehlem said. “I wish they would have just done it then.”
In another example of MAUDE’s limitations, Kuehlem’s case appears in the database as an infection, rather than the more serious sepsis episode that it was.
Just as data on operative complications are lacking, it’s difficult to get a handle on endometrial ablation “failures” like a worsening of heavy bleeding, cyclic pelvic pain, or scarring that masks uterine cancer — complications that are typically categorized as “post-ablation syndrome.”
Chrissy Nuzzo of East Stroudsburg, Pennsylvania, says she had severe pain every month from her NovaSure ablation.
The 41-year-old mother of four had ablation with NovaSure in February 2016 after many years of unsuccessful dilation and curettage procedures to control her heavy periods.
The ablation stopped her bleeding for about four to five months, she told MedPage Today, but then she began spotting with blood for about two weeks each month.
“It was dried blood that was stuck behind the scar tissue, it couldn’t come out,” she said “So it would build up and dry up there and then whatever could seep through the scar tissue” would drip out.
About eight months after her ablation, she was “bleeding brown, and in pain and bloated” for five or six days of those two weeks, and hurting so badly that she couldn’t get out of bed.
Sometimes, Nuzzo would call her mother to help her through what she calls a “cycle attack.”
“I would make my mother stay on the phone with me because it was so bad, I would get scared that I would die,” Nuzzo said.
The pain was unlike anything she’d experienced. “I had four kids. Three with epidurals, one without, and I will tell you, I would give birth before feeling these pains,” Nuzzo said.
“I mean, it was to the point where it was every month in the hospital on tramadol,” she said.
After moving to Pennsylvania from Orange County, New York, Nuzzo found a new ob/gyn who read the reports of her monthly emergency department visits and recommended a total hysterectomy.
Nuzzo was 39 at the time, and that felt young for a hysterectomy, she said, but she was not planning to have any more kids.
She had the procedure, and while she worries about its long-term consequences, she says it has helped her. It also revealed extensive scar tissue throughout her uterus, fueling her suspicion of having “post-ablation syndrome.”
She formed a Facebook group called “Post-ablation Syndrome Support Group,” which now has about 300 members. The administrator of the larger Facebook group that lists 5,000 members, called NovaSure & Other Endometrial Ablation Procedures Info & Support, declined to be interviewed for this story.
“These women are on pain meds, they can’t function,” Nuzzo said. “They are not able to take care of their little kids. They are not able to take care of their home. They’re not able to get out of bed.”
Post-ablation syndrome is one of the names in the medical literature used to describe symptoms like Nuzzo’s. Another is “late-onset endometrial ablation failure,” which was coined by Morris Wortman, MD, a gynecologist in Rochester, New York, who has become an expert in complications of endometrial ablation.
Wortman said these complications include a recurrence or worsening of abnormal bleeding, cyclic and intense pelvic pain, and not being able to look inside or sample the uterine cavity because of severe scarring, which can make the detection of uterine cancer challenging.
He pointed to smaller studies that have suggested that about a quarter of women who have an endometrial ablation will eventually require a hysterectomy — and that significantly more will be unsatisfied with the result of their ablation but won’t pursue further surgery, he said.
One study, a retrospective analysis of about 3,700 patients from Kaiser Permanente Northern California who had an ablation, found 21% of women had a subsequent hysterectomy, and 4% had “uterine-conserving procedures.” That rate was higher for younger women: 40% of those age 40 and under had a subsequent hysterectomy.
Ablation invariably leads to scarring of the uterus, but sometimes endometrium can regrow underneath that scarring, McCausland said. Pools of blood can then build up, unable to escape, resulting in hematometra that can cause pain, usually to the pattern of a monthly cycle.
Similarly, if an ablation patient has also had tubal ligation and endometrium remains in the corners of the uterus that connect to the fallopian tubes, blood can back up into the tubes causing swelling that looks like an early ectopic pregnancy and cyclic pain. This is the “post-ablation tubal ligation syndrome,” or PATSS, that McCausland and colleagues first described.
They followed 50 of their patients who had rollerball endometrial ablations, nine of whom had a previous tubal ligation, and three of them ended up with PATSS, McCausland said.
One of those patients was a family friend of McCausland’s. He said he never performed another full ablation after that. Instead, he’d only do partial ablations.
McCausland expresses even greater concern about uterine cancer after endometrial ablation, which can be problematic in two ways.
First, if the uterus is sealed shut due to extensive scarring, postmenopausal women who have uterine cancer may never receive the early warning sign of bleeding. Without that sign, cancers may be diagnosed at a later stage, McCausland said.
If the patient does bleed or has some other symptom that makes the doctor suspicious of endometrial cancer, and the scarring prevents an examination with conventional methods like transvaginal ultrasound and endometrial biopsy, the patient has to get a diagnostic hysterectomy.
“It’s a major surgery and some 90% probably won’t have cancer,” McCausland said.
Most studies have shown no increased risk of endometrial cancer following uterine ablation, though they’ve typically been smaller, retrospective, single-center studies. A few papers detail about 25 cases of post-ablation uterine cancer, several of which are from Wortman’s practice.
That’s the problem for all of these late-onset complications of endometrial ablation failure, Wortman said.
“No one is doing adequate research, looking at a large volume of women prospectively, to determine how and why they fail,” Wortman told MedPage Today.
Ali Ghomi, MD, an ob/gyn in Buffalo, New York, echoed Wortman’s concerns about a lack of data for women to make informed decisions about endometrial ablation.
“The issue has not been fully investigated when it comes to post-ablation syndrome,” Ghomi told MedPage Today.
“We need to be able to say, okay, what’s the percentage who need hysterectomy for pain? What’s the percentage who end up having a missed diagnosis of uterine cancer? What’s the percentage who need hysterectomy for postmenopausal bleeding that could not be investigated to make sure it was not uterine cancer?”
“At least we could provide better counseling when we offer the ablation procedure,” he said, adding that he does very few ablations each year, and only in very well-selected patients.
Given that some 25% of the 300 hysterectomies he performs each year are done to repair post-ablation syndrome, he believes the procedure is overused.
“I think the more information everyone has,” Ghomi said, “the better off patients are.”
Uterine Fibroid Embolization: A Much Better Treatment Option for Fibroids
When someone has heavy uterine bleeding from fibroids, the problem is due to the fibroids not the lining per se. Therefore, burning the lining with an ablation procedure is not likely to take care of the problem. In addition, the fibroids not only cause heavy bleeding but often also cause bulk-related symptoms (exs. pelvic pain, bloating, increased urinary frequency) which are not addressed at all by an endometrial ablation.
The much better approach to treating fibroid-related bleeding is with Uterine Fibroid Embolization (UFE). Unfortunately, many Gynecologists don’t mention UFE as a treatment option since they are not trained in this treatment option. That’s why it is so important for women to know all of their treatment options. If you are suffering with fibroids, make an appointment to see one of the nation’s leading fibroid experts, John C. Lipman, MD Founder & Medical Director of the Atlanta Fibroid Center by calling 770-214-4600, or make an appointment online.