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. 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. 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.
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.
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. 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. It was April and at first, everything was fine. She had no pain from the procedure and she was feeling good the next morning, a Saturday. 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. Shelly Kuehlem center right with her family. Kuehlem developed sepsis as a result of two perforations from her endometrial ablation with NovaSure. Photo by ByWise Photo. 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. 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 had a hysterectomy to control her post-ablation pain. Photo provided by Chrissy Nuzzo. The year-old mother of four had ablation with NovaSure in February 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. 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. The pain was unlike anything she'd experienced. Three with epidurals, one without, and I will tell you, I would give birth before feeling these pains," Nuzzo said.
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. Pregnancy after an endometrial ablation is unlikely, but possible , which is potentially dangerous. If pregnancy does happen after ablation, serious and sometimes deadly complications can occur. This type of surgery is not an alternative to a hysterectomy or sterilization surgery, so talk to your doctor if that is one of your needs.
Women should still use forms of birth control after uterine ablation, as pregnancy remains possible until after menopause. Largely, back pain is not normal, though some abdominal cramping immediately following the surgery is to be expected.
In rare cases, some women develop cyclic pelvic pain CPP after the procedure, which can last for months or even years. This may be a potential indication of late-onset endometrial ablation failure. If you experience back pain after the surgery, call your doctor. Immediately after surgery, women should expect cramps, some vaginal discharge and frequent urination. In the follow-up after endometrial ablation, excessive bleeding, holes in the uterus, impacts on other organs and discharge should be watched carefully.
Talk to your doctor about the details of your specific procedure for endometrial ablation. Healthcare providers consider menstrual flow to be too heavy if your tampon or sanitary pad is routinely soaked through within 2 hours , according to the Mayo Clinic.
While in most cases the endometrial lining is destroyed, regrowth of the lining can occur in normal and abnormal ways. In younger women, tissue regrowth may occur months or years later.
Talk to your healthcare provider about whether this is the best option for you. Prior to scheduling, your healthcare provider will request your medication history, including any allergies you have. Your uterine lining may need to be thinned beforehand to make the procedure more effective. This can be done with medication, or with a dilation and curettage D and C procedure.
Not all endometrial ablation procedures require anesthesia. Additional preliminary tests, such as an electrocardiogram , may also be done. Although your reproductive organs remain intact, conception and successful pregnancy afterward is unlikely. You should discuss your reproductive options with an infertility specialist before having the procedure. If your eggs are of good quality, you can opt to freeze your eggs or fertilized embryos prior to the procedure. A surrogate might carry the pregnancy for you.
If you can choose to delay the procedure until you have children, you might want to do so. Adoption is also a consideration. Weighing these options, as well as the need for the procedure, may feel overwhelming. Talking to your healthcare provider about your feelings may be beneficial. They can recommend a counselor or therapist to help you process and provide you with support. In an endometrial ablation, your healthcare provider first inserts a slender instrument through your cervix and into your uterus.
This widens your cervix and allows them to perform the procedure. The procedure can be done in one of several ways. Freezing cryoablation : A thin probe is used to apply extreme cold to your uterine tissue. Your healthcare provider places an ultrasound monitor on your abdomen to help them guide the probe.
The size and shape of your uterus determines how long this procedure lasts. Heated balloon: A balloon is inserted into your uterus, inflated, and filled with hot fluid.
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