This is the second story in a series by 麻豆传媒 on endometrial ablation for heavy menstrual bleeding. The first story focused on complications reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Here, we look into physicians' evolving attitudes toward the procedure.
Linda Bradley, MD, the medical director of the American Association of Gynecologic Laparoscopists (AAGL), the medical society at the forefront of minimally invasive gynecologic surgery in the U.S., no longer performs endometrial ablation.
"I stopped ... over personal concerns about treatment failures," Bradley, who practices at the Cleveland Clinic, told 麻豆传媒. "I think there are better ways to manage abnormal bleeding for the majority of patients."
Bradley is not alone. Several other physicians told 麻豆传媒 they no longer do endometrial ablation, or they perform it only selectively. Ali Ghomi, MD, of Sisters of Charity Hospital in Buffalo, does no more than five ablations each year. Arthur McCausland, MD, a retired ob/gyn in Sacramento, said he stopped doing full ablations in the early 1990s after a family friend developed severe labor-like pain after the procedure and needed a hysterectomy. Diana Bitner, MD, rarely does the procedure.
"When endometrial ablation first came out, we all thought it was the best thing since sliced bread. A month later, patients didn't bleed, they were happy," Bitner told 麻豆传媒. "Then six, eight months later, they're failing."
The potential for ablation failure -- severe pain resulting from endometrial regrowth and blood trapped under scar tissue -- is one of the main reasons for avoiding the procedure, the doctors said. They've also raised concerns about operative complications from a procedure that's touted as less-than-minimally invasive, including perforation, sepsis, and even death, as a 麻豆传媒 analysis of the FDA's device adverse event reporting database found.
Endometrial ablation appears to be safe and effective for many women, and other physicians have told 麻豆传媒 they still perform the procedure and it helps many of their patients. Others believe it may be overused and that patients aren't always selected appropriately. The procedure pays well, and some physicians have taken tens of thousands of dollars from Hologic for NovaSure, the market leader.
"I think we've become more complacent when it comes to performing these procedures in recent years because of the notion that it's least-invasive [and] can be done in an office setting, and doesn't have that much downside," Ghomi said. "I think we have to revisit ... the nature of the procedure" and its potential for adverse effects.
Treating Heavy Menstrual Bleeding
Some 10 million women in the U.S. suffer from menorrhagia, or heavy menstrual bleeding, .
If there's no other underlying cause, such as polyps or fibroids, national and international treatment guidelines recommend a levonorgestrel intrauterine device (IUD) as first-line therapy. Tranexamic acid and oral contraceptives are other appropriate early treatments, according to guidance from both the (ACOG) and the .
If those don't work, ACOG's guidelines advise surgical options, including endometrial ablation. But that guidance has a specific caution for the procedure.
"Endometrial ablation, although readily available in most centers, should be considered only if other treatments have been ineffective or are contraindicated, and it should be performed only when a woman does not have plans for future childbearing and when the possibility of endometrial or uterine cancer has been reliably ruled out as the cause of the acute abnormal uterine bleeding," the ACOG guidance states.
Endometrial ablation has been seen as a way to reduce the number of hysterectomies in the U.S. -- a procedure that has also come under scrutiny for being overdone, and one that carries more risks than ablation.
Ronald Sancetta, MD, an ob/gyn in private practice in Miami, said his hysterectomy rate dropped by 95% after he started offering ablation.
"You can eliminate the need for hysterectomy in many cases," Sancetta said. "You don't have the risks or dangers of hysterectomy." But he also told 麻豆传媒 that he stopped using NovaSure after seeing too many failures and switched to a different system.
Ghomi runs the robotic hysterectomy program at his hospital in Buffalo, but he agrees a major surgery shouldn't be a first-line treatment for heavy bleeding.
In randomized trials comparing an IUD with endometrial ablation and hysterectomy, "the procedure that always wins is IUD insertion," Ghomi said.
"It's reversible, it can be removed without difficulty," he said. "It's being underutilized."
"I think my colleagues, as a whole, have become more liberal in recent years offering endometrial ablation, and in pushing the envelope in terms of selection criteria," Ghomi said. "As a result, we're seeing more post-ablation syndrome."
Patient Selection
Post-ablation syndrome describes the symptoms of pain or a return to heavy bleeding that often leads to hysterectomy, as 麻豆传媒 reported in an earlier story in this series.
NovaSure, the most commonly used endometrial ablation device, which is estimated to have at least 60% of the endometrial ablation market, is indicated for premenopausal women with menorrhagia "due to benign causes for whom childbearing is complete."
Contraindications in the device's (IFU) -- the equivalent of a drug label -- include pregnancy or a desire to become pregnant, endometrial cancer, anatomic conditions such as classical cesarean section or transmural myomectomy, genital or urinary tract infection, IUD implantation, small uterine cavity, and active pelvic inflammatory disease.
In addition to these "absolute" contraindications, Ghomi said, doctors are starting to learn that there are "soft" ones as well, such as younger age, polyps, fibroids, painful periods, and any type of cesarean section.
Some doctors might still perform the procedure in these circumstances, and that's when complications such as post-ablation syndrome or perforations at the time of surgery are more likely to occur, he said.
Hologic spokesperson Marcia Goff said the company continuously assesses the "appropriateness of all our product IFUs based on clinical trial data and reports from healthcare providers and patients" and any changes are approved by regulatory authorities.
"Based on our nearly 20 years of experience with NovaSure in the field, we believe its IFU is appropriate," Goff said.
Still, Ghomi says his ideal candidate for endometrial ablation would have the following characteristics:
- Abnormal uterine bleeding
- At least 45 years old
- Normal sized uterus without any pathology (i.e., normal uterine biopsy and Pap smear)
- No polyps or fibroids on ultrasound
- No history of C-section or tubal ligation
- No history of endometriosis or pain
- No painful periods
"I think the problem we're facing now is that type of candidate is probably less than 1% of the patients that do receive endometrial ablation," Ghomi said.
Earl Elowsky, MD, an ob/gyn in Tawas City, Michigan, said some "physicians and patients are too cavalier" about endometrial ablation and the procedure is "not perfect and certainly not the solution for everyone."
"But they work in a large number of people and are significantly safer than hysterectomy," he said. "As with anything else, you have to select people carefully and counsel them thoroughly and appropriately."
As for guidance about patient selection for the physician doing a NovaSure procedure, the label states that there are many causes for menorrhagia and that physicians should consult the medical literature before performing any ablation procedure.
Ablation for 'Nuisance' Bleeding
Sue Ferrier didn't have heavy menstrual bleeding when she was referred for a NovaSure procedure in 2011.
After months of frustration with a "brownish, very light" discharge, Ferrier, now 54, of Burks Falls in Ontario, Canada, reached out to her primary care doctor. The discharge was merely "a nuisance," she said, but one that was affecting her life and her marriage.
Her doctor ran some tests and found no infection and "nothing rare," and so she referred Ferrier to an ob/gyn practice to have an ablation.
Ferrier wasn't on board immediately. She was otherwise healthy, wasn't in any pain, and wondered whether undergoing a procedure made sense.
At the ob/gyn clinic, Ferrier said she wasn't told much about the ablation beyond that it would burn the lining of her uterus and either totally eliminate her period and the discharge or at least diminish it.
She was told there would be a degree of risk, as there is with any procedure, Ferrier said.
"I don't remember a whole lot of negative [talk] or I probably wouldn't have gone for it. I'm a little bit of a fearful person to begin with," she said. But she eventually convinced herself not to "overthink it, it's a 90-second procedure. Its rates of success are, you know, way, way up there. So, let's go for it."
She underwent NovaSure ablation in October 2011 and was told that it "went off without a hitch, no problem," and was "one of the easiest" procedures her ob/gyn had ever done.
About three days later, she woke up "moaning in pain" and told her husband she needed to go to the hospital. Although she lives less than 15 minutes from the emergency room, by the time she arrived, she had no memory of what happened. She relies on her husband's memory instead.
He told her about her blood pressure "bombing out," her sky-high heart rate, and being transferred to another hospital for an emergency hysterectomy. She had sepsis severe enough to require a medically-induced coma.
She went home 10 days later, but within a week began to feel sick again. Doctors found an abscess, which Ferrier opted to let drain on its own, but she was soon back at the hospital as she continued to get weak.
Her subsequent 12-day hospital stay was "brutal," she said.
"I was ready to pass on. I had very little desire to fight. I was exhausted. I was sick."
Doctors gave her the strongest medicines they had and were even nervous to finally send her home in December 2011 in time for her youngest son's birthday.
Ferrier says she has lingering consequences from her ordeal. She can't read more than a short chapter of a book without losing focus. She used to manage her family's finances, but now has trouble with math. She can't work because under any form of time pressure, "my mind goes blank." She's currently on disability and her son, who works in construction, gives her some small jobs to do that aren't time-sensitive.
She gets anxious any time she gets sick: "If I lose my appetite to any degree, I panic."
Ferrier does puzzles to try to improve her attention span, lifts weights and, during warmer weather, rides her bicycle to improve her strength.
"In case anything hits again," she said, "I'll be a little stronger."
Neither her primary care doctor nor the ob/gyn practice where she had the ablation returned 麻豆传媒's request for comment.
Informed Consent
It's difficult to assess individual consent discussions, but like Ferrier, other women interviewed by 麻豆传媒 who suffered complications said they felt the risks were given short shrift by their physicians.
Michelle Louie, MD, an ob/gyn at the University of North Carolina Chapel Hill, is a referral provider who treats only tough gynecologic cases. She says many patients come to her with endometrial ablation failures.
"I've seen people who have failed who might not have been counseled about the temporary nature of the procedure," Louie told 麻豆传媒.
Louie rarely offers an ablation, but when she does, she says she's upfront about its risks and the likelihood that it's a temporary solution. She doesn't offer it to younger women, especially those in their 20s or 30s, because of concerns about failure and post-ablation syndrome.
"Studies done for this device were probably not followed up long enough to truly evaluate what happens to younger women," she said.
She counsels them about the "high likelihood that they will require another procedure when endometrial ablation has reached the end of its effectiveness."
For example, she might recommend it to a patient who has young kids and can't commit to a hysterectomy now, but may be able to have the surgery a few years down the line. Or if a patient with a history of tubal ligation really wants endometrial ablation, she'll discuss the possibility of post-ablation tubal sterilization syndrome.
"If they understand that, if they're making a fully informed choice, I think ablation can be appropriate," Louie said. "It's not that you can't offer it, but you have to be thoughtful about making sure patients really understand these finer points."
"I would never counsel my patient to have a temporary procedure unless she's really aware and totally at peace with that," Louie added. "She would acknowledge that it's temporary, and that that's what she wants at the time."
Not all doctors describe ablation as a temporary procedure. Denise Sweeney, MD, an ob/gyn in Roseville, California, said she offers ablation to patients who are certain they're done having children. While she does encourage an IUD first, she said many don't want hormones, so ablation becomes a good option.
She said she cautions all her patients about post-ablation syndrome, especially those with adenomyosis, as "ablation can make them worse. But even if they have adenomyosis, a lot of them choose to try ablation hoping it will be good enough so they don't have to get a hysterectomy."
Sweeney, who uses NovaSure with most ablations, said she was surprised to read about high follow-up hysterectomy rates and that hers are very low.
Physicians who look to the patient counseling section of the NovaSure label would learn that they should discuss the risks and benefits of ablation as well as treatment alternatives. They'll also find information about the dangers of getting pregnant following an ablation; common post-procedure complications like discharge, cramping, nausea, vomiting, and signs of perforation that should be reported immediately.
There's nothing in that section about the risk that the procedure simply won't work. Elsewhere in the document, in a section titled "clinical observations," a table shows a 6.3% rate of hysterectomy within three years of the procedure. Other studies, however, put rates for subsequent hysterectomy much higher, at 20% or more. One in 2008 showed a 40% likelihood of needing a subsequent hysterectomy through 8 years of follow-up among ablation patients under 40.
Financial Incentives
When asked about potential financial incentives to perform endometrial ablation, Louie said she hopes that most providers "offer what they believe are the right options for this patient. If this were my mom, my sister, my best friend, what would I advise?"
"But is there a gain to doing endometrial ablation and if it fails, doing hysterectomy? You know this is generally safe, and that there's a backup if it fails," she mused.
Reimbursement for endometrial ablation -- which is touted as a quick fix that can be done right in a doctor's office -- is high. According to data provided by , a service that uses private insurance claims data to help patients better understand the cost of their healthcare, the average allowed in-network amount paid to physicians for two procedure codes frequently used for endometrial ablation was $1,057 and $1,678 , respectively.
In the case of NovaSure, there can be additional financial incentive from Hologic. According to the federal Open Payments database, Hologic has spent $306,000 on 3,282 doctors since 2013 for NovaSure programs.
Well over half of that went to a single physician: , in private practice in Evansville, Indiana, who made over $175,000 from Hologic for NovaSure from 2016 to 2018.
Basinski told 麻豆传媒 the money was for a about heavy menstrual bleeding, as well as for physician education about heavy menstrual bleeding, including speaking on panels and at national meetings.
In a career of about 20 years, Basinski's website says she has performed "nearly 3,000 in-office endometrial ablations such as NovaSure" -- a figure that other ob/gyns characterized as high. Basinski said that she focuses on gynecologic surgery and doesn't deliver babies or do other routine gynecologic work.
Basinski said she discusses the risks and benefits of all options when a patient comes to see her for heavy menstrual bleeding, whether it's oral contraception, having an IUD inserted, endometrial ablation, or hysterectomy.
She notes that hormonal therapy may fail for half of women, and an IUD can also carry complications like perforation, she said. She and the patient also take into account insurance coverage and costs.
"Women are good at choosing what they want," Basinski said. "If they made that decision to use that product, they accept that risk."
When it comes to ablation, she estimates the success rate at about 80%, and she tells younger women there's a higher chance of needing another procedure if they choose ablation.
"The longer you have to rely on an ablation, the more chance it has to fail for you," she said. "If it fails, they may say, I got 8 great years of this ablation and I'm super happy about that. But for 8 of 10, I've solved their problem."
Unfortunately, no post-marketing data have been published for NovaSure (the FDA required a focusing on an issue specific to that product). comparing NovaSure with a competitor called Minerva for success rates, adverse events, and patient satisfaction. NovaSure ended up the winner, but the paper stirred controversy in April 2018 when Minerva Surgical demanded (unsuccessfully) that it be retracted because of "material misleading statements" about the nature of the study, according to a .
Hologic also funded a that looked at publicly available data on safety and efficacy: a mix of prospective studies, single-arm NovaSure trials, and trials comparing NovaSure with other second-generation devices. It found NovaSure generally superior for short-term outcomes such as amenorrhea in the first year, but didn't address longer-term durability or safety. Notably, although Hologic provided "editorial and indirect financial support" for the study, the company didn't share its internal data with the author.
"That's the problem with medicine," Basinski said. "We don't have good data for everything we do. But we don't have that for lots of things in our lives."
Basinski had a NovaSure endometrial ablation herself when she was 37, and hasn't had a period in the 13 years since; nor has she experienced endometrial ablation failure. NovaSure "was a great option for me," she said, and she discusses her experience in a .
Regarding physician payments, Hologic spokesperson Goff said the company "works with independent physicians to conduct clinical trials of our products, to educate other healthcare providers on the proper use of our products, and to inform future research and development efforts. And like all medical device companies, we compensate these physicians for their valuable time."
"If we didn't work with clinicians in this way," Goff added, "we would not be able to develop new medical devices, and products already on the market might not be used properly."
The debate over whether endometrial ablation is being used properly is likely to continue, as "medicine is an art as well as a science," AAGL's Bradley said. "We have our opinions about what we see in the patients ... we've taken care of how that may cloud how we look at things."
Cheryl Clark contributed reporting for this story.