Can Endometrial Ablation Help You? I am bothered by the amount of bleeding during my periods. My period makes me feel depressed, tired, anxious or moody. I am afraid of having an embarrassing accident. I have PMS symptoms, such as headaches, during my period. I bleed more than once a month.
My period lasts too long. My period affects my social, athletic or sexual activities. I have a problem working due to my period. My life would improve if I could decrease or completely eliminate my period. I lack confidence due to my period. I have less energy or a total lack of energy during my period. I experience painful periods.
Choosing the Right Heavy Period Treatment for You In addition to NovaSure, there are other treatment options for excessive menstrual bleeding including medication, hormonal contraceptives like birth control pills or intrauterine devices, or IUDs and surgery hysterectomy.
Patient Testimonials. I had some issues that gave me the end result of needing a hysterectomy. I first saw Dr. Cook, and let me say she is amazing! She made me feel comfortable and explained my situation to me and I felt well informed.
Agrios did my surgery and he is amazing, as well! They show concern and have very good bedside manner. As inputs to the commercial payer version of the model, Table 5 shows the monthly probability of work absence or work loss from short-term disability and the corresponding number of days of lost work.
Analytical results generated by the model include an assortment of comparative clinical and economic outcomes, with presentation of incremental cost-effectiveness ratios ICERs for NovaSure versus other GEA and NovaSure versus hysterectomy.
Clinical outcomes include total and incremental QALYs, total and incremental cases of treatment complications, and total and incremental reinterventions and reintervention hysterectomies for the NovaSure versus other GEA analyses only. Work productivity outcomes US commercial payer perspective only included total and incremental number of work days lost due to worker absence and short-term disability.
Economic outcomes include total and incremental direct costs due to worker absence and short-term disability. Cost-effectiveness outcomes include cost per QALY, cost per complication case avoided, cost per reintervention avoided, cost per reintervention hysterectomy avoided, and cost per work day saved. Although the model was programmed to simulate any time horizon from 1 month up to 5 years and 10 years as a sensitivity analysis , we selected a few key time points over a 5-year horizon that would be of universal interest, and they are referred to here as Year 1, Year 3, and Year 5.
A variety of univariate and probabilistic sensitivity analyses PSAs were conducted to test the robustness of model parameter values and their impact on the ICERs.
The parameter values of each probability distribution were calculated from the mean and standard error of the model input parameters. By drawing randomly from those distributions, a large number of estimates of costs, QALYs, and ICERs were generated, thus testing the consequences of varying input parameters. Targeted one-way deterministic sensitivity analyses were performed on the ICERs featuring complications, reinterventions, reintervention hysterectomies, and work productivity.
A year analysis scenario was performed to test robustness of the model estimates over long time horizons. Results of the model analyses show lower total direct costs for NovaSure-treated patients than for patients treated with other GEA modalities or hysterectomy over all time frames under both the commercial payer and Medicaid perspectives Table 7. The cost differential between the treatments narrowed somewhat over time, but even at Year 3 and Year 5 NovaSure costs were still one-third less than hysterectomy costs.
For example, in the 1-year analysis, NovaSure patients lost Quality-of-life outcomes, measured in terms of QALYs, were higher for NovaSure-treated patients than for those treated with other GEA over all time frames under both the commercial payer and Medicaid perspectives Table 7.
For NovaSure versus hysterectomy, QALYs were higher for NovaSure in the Year 1 analysis results, but favorability shifted to hysterectomy in the Year 3 and Year 5 results — a phenomenon attributable to the inherently higher long-term utility weights assigned to hysterectomy, but also due to the cumulative disutility experienced by NovaSure and other GEA patients undergoing repeat ablation and other forms of reintervention naturally avoided by hysterectomy patients.
For example, whereas The gap narrows over time as the initial complications of hysterectomy remain constant, while reintervention complications for NovaSure and GEA patients gradually accumulate. Results were similar under the Medicaid perspective.
Cost-effectiveness metrics show NovaSure treatment as economically dominant over other GEA modalities in all circumstances. This represents the potential for improved outcomes among women treated with the NovaSure system ie, greater QALYs, fewer complications, fewer reinterventions, or fewer work days lost at lower cost compared with other GEA modalities. Similar results were shown for the NovaSure procedure versus hysterectomy, where NovaSure was typically the dominant strategy ie, always conferring greater benefit at lower cost.
Results were not highly sensitive to univariate and probabilistic variation in the parameter values — that is, the changes did not appreciably alter the ICERs including economic dominance , nor did they generally affect conclusions about the cost effectiveness of the NovaSure procedure. Focusing specifically on the cost-per-QALY ICERs in the 5-year scenario, where the analysis results were somewhat anomalous by showing decremental cost effectiveness for the NovaSure procedure versus hysterectomy, none of the plotted ICER points fell into the upper quadrants of the cost-effectiveness plane — ie, NovaSure treatment consistently always costs less than other GEA modalities and hysterectomy, even under the extremes of probabilistic sampling.
As an additional sensitivity analysis, a special year scenario simulation was performed to explore results projected over a long time horizon. Incremental cost differences remained highly favorable for the NovaSure procedure in both the commercial payer and Medicaid perspectives, and indirect costs attributable to work absence and short-term disability leave in the commercial payer perspective also remained advantageous.
Cost-effectiveness results seen at Year 5 continued a trend into Year 10, with the NovaSure procedure mostly showing economic dominance over other GEA and hysterectomy in both the commercial and Medicare perspectives.
Results of this economic modeling study of AUB show that the direct and indirect costs of NovaSure treatment of AUB are substantially lower than those for other GEA modalities and hysterectomy over short 1-year and longer 5-year time horizons, and under both commercial payer and Medicaid perspectives.
Similar results were found for indirect costs, under the commercial payer perspective. Combining these cost savings with clinical and quality-of-life benefits of treatment yielded cost-effectiveness metrics favoring the NovaSure procedure over other GEA modalities and hysterectomy as an AUB treatment strategy.
In almost all scenarios analyzed, NovaSure treatment was found to be the economically dominant strategy over other GEA and hysterectomy — that is, NovaSure treatment confers better clinical outcomes and quality-of-life benefits at less cost. As would be expected, given the technical similarities between the NovaSure procedure and other GEA modalities, comparative results for NovaSure treatment versus other GEA are more modest.
The Medicaid perspective analyses from this study are particularly relevant given recent expansion of the US Medicaid program and the creation of new state-based and federally facilitated competitive marketplaces, or Affordable Insurance Exchanges.
Consequently, state-based and federally facilitated exchanges may focus intently on GEA particularly on less costly, in-office procedures with the NovaSure procedure as ways to reduce costs. There were some data limitations in our study, most of which are inherently tied to using an administrative health care database as the primary data source for the economic model. First, as observed in other retrospective claims database analyses, the most completely recorded data are those that affect reimbursement.
Hence, the capture of expenditures is highly accurate, but data on comorbidities and disease severity may not be as carefully recorded.
Analyses of these different procedure types may have revealed differences in clinical and cost outcomes from the model, but it is not possible to speculate about the magnitude and direction of those differences.
Third, due to the structure of the underlying claims database analyses, we did not conduct age-stratified subgroup analyses with the model, although patient age may correlate with clinical and economic outcomes. Fourth, the indirect costs included in this analysis are not exhaustive. For example, absenteeism and short-term disability claims do not include transportation costs to and from medical appointments, caregiver time, childcare time, long-term disability, or reduced productivity while at work.
We also note that although the literature provided health state utility values sufficient for use in the economic model, they are mostly from older studies, some of which predate the advent of second-generation endometrial ablation technologies notably, the extensively referenced cost-utility analysis by Sculpher.
This high regard for NovaSure treatment is reflected by the results of our economic model, which show strong financial favorability for the NovaSure procedure over other GEA modalities and over hysterectomy from both the commercial payer and Medicaid payer perspectives.
Results from this study will interest the US commercial health payers and self-insured employers seeking cost-effective treatment for AUB. Similarly, new federal mandates for Medicaid expansion are likely to focus on the attractiveness of outpatient treatments like the NovaSure procedure and other GEA modalities to reduce Medicaid costs. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
National Center for Biotechnology Information , U. Int J Womens Health. Published online Jan 6. Author information Copyright and License information Disclaimer. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. This article has been cited by other articles in PMC.
A month later, patients didn't bleed, they were happy," Bitner told MedPage Today. 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 MedPage Today 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 MedPage Today 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. Some 10 million women in the U. 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 American College of Obstetricians and Gynecologists ACOG and the U. 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 has been seen as a way to reduce the number of hysterectomies in the U. 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.
Post-ablation syndrome describes the symptoms of pain or a return to heavy bleeding that often leads to hysterectomy, as MedPage Today reported in an earlier story in this series. Contraindications in the device's Instructions for Use 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.
Still, Ghomi says his ideal candidate for endometrial ablation would have the following characteristics:. 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.
During abdominal pain during periods, she used to take drotin-m and calpol for last 9 to 10 years. Please give your opinion in this regard. Thanking you in anticipation s. Nikitha Murthy. Gynaecologist, Bangalore. Hello, yes the pain and heavy bleeding is most likely because of the fibroids. However following menopause fibroids usually shrink and stop producing these symptoms. Since your wife is already 47 years old. My advice is to manage the symptoms with Last month I started meprate twice for 10 days but even after 15 days did not get periods back.
So now how and on which day should I start again my course of hrt evatone2 and meprate to start my periods? Can I start from tomorrow the full course again as I was taking earlier?
Please suggest the course and when to start. Inthu M. MBBS, M. Gynaecologist, Chennai. As you said you don't have the ovarian reserve that is there is premature ovarian failure you need to have priming of endometrium with the estrodiol tablets prior to taking meprate.
I am on hrt rvatone and meprate for last 1 years due to premature ovarian failure. I stopped medicine 4 months back. So did not get periods. Last month I started meprate twice for 10 days but it has been even 14 days now but I am not having periods. How to start periods now? Barnali Basu. Gynaecologist, Guwahati. Since you have premature ovarian failure, taking only meprate won't help unlike others who have anovulation. You need to take evatone along with meprate to get your periods.
Sameer Pahlajani. IVF Specialist, Raipur. Vaginal bleeding is a common phenomenon in women. Sometimes it is due to cyclical changes in the cycle, while other times, it may be indicative of something unnatural and perhaps severe.
Abnormal vaginal bleeding includes: Heavy periods: This is a Vidya Shetty. Gynaecologist, Thane. A hysterectomy is an operation to remove the uterus and, usually, the cervix. The ovaries and tubes may or may not be removed during this procedure, depending on the reasons for the surgery being performed. If the ovaries are removed, you will com Pooja Kadhi. Gynaecologist, Raipur. Uterine fibroids are benign tumours that develop within the uterus during a woman s reproductive years when the levels of oestrogen hormone are high.
Premature Ovarian Failure - Know More!
0コメント