Gynecare Thermachoice | Endometrial Ablation | Balloon Device

GYNECARE THERMACHOICE® Uterine Balloon Therapy System is a minimally invasive treatment developed to reduce excessive menstrual bleeding in pre-menopausal women who are having heavy periods due to benign causes. It is a Uterine Balloon Therapy (UBT) System where a thermal balloon ablation device is used to ablate the endometrial lining of the uterus in women with Menorrhagia after childbearing is complete. It is a one-time outpatient procedure that removes the endometrium. For most women, it treats heavy bleeding. Very little of the endometrium grows back and heavy bleeding is much less likely to continue.

In total it takes about 30 minutes to perform and is simple, minimally-invasive and requires no hospital stay. It uses heat to treat the endometrium (the lining of the uterus) and can be performed under local anaesthetic. It requires no incision and minimal pain is felt by the patient. Unlike a hysterectomy, GYNECARE THERMACHOICE® allows a patient to preserve their uterus. Recovery is fast with many women return to their normal activities the next day.

93% of women are satisfied with the result after 5 years and prior to the procedure, more than 70% of these women felt that their heavy periods had been having a negative impact on their lives. Following treatment, only about 2% felt that way after 3 years.

Nearly 3 out of 4 of women treated 3 years (post-treatment) experienced a reduction in menstrual pain and cramping associated with their period. Nearly 2 out of 3 women reported mild or no PMS symptoms at 3 years. Three years after being treated, 80% of women had either normal, light or no bleeding at all³.

Uterine endometrial balloon therapy (UBT) for the treatment of Menorrhagia significantly reduces the probability of hysterectomy avoidance. After 4-6 years, the probability of avoidance of a hysterectomy is 86% and avoiding re-ablation is 88% for non-hysterectomized women. Overall, the probability of avoiding surgery was 75%¹. The high rate of avoiding a hysterectomy over a long period of time means that UBT offers woman who are reluctant to have a hysterectomy the dual advantage of conservative surgery and freedom of anxiousness regarding medical therapy.

UBT is less traumatic for the patient than a hysterectomy and is associated with less postoperative morbidity and a shorter recovery time⁴. The fact that UBT can also be performed as a day surgery with or without general anaesthesia makes it even more appealing to patients. In a study by Amzo et al, it was found that 91% of women who had one ablation only and had not undergone a hysterectomy experienced none to normal periods⁴. The same study also found that uterine position had an impact on whether or not a patient would require re-ablation. It was found that the probability of not having re-ablation in non-hysterectomized women was 77% for the retroverted uterus, 83% for axial position and 94% for women with anteverted uterus⁴.

In a study conducted by Badia, Nyirjesy and Atogho (2007), it was found that major complications in the use of endometrial ablation devices were significantly lower (11.6% from closest competitor) for GYNECARE THERMACHOICE® when compared with competing products5. With only 3 events being reported in 2005 and 6 in 2006 after the release of GYNECARE THERMACHOICE® III⁵.

In 2006, a study investigated GYNECARE THERMACHOICE® III in the outpatient setting versus the daycase setting. It found that 87% of patients were able to complete the 8-minute procedure in the outpatient setting with 64% requiring no rescue analgesia⁶. The majority of the women rated pain as none to moderate and significantly fewer women experienced nausea (13% vs 65%), vomiting (0% vs 24%) or required postoperative antiemetics (0% vs 56%) when compared with the daycase procedure⁶. The outpatient procedure lasted 1 hour 40 minutes as opposed to the day case where it lasted 8 hours and 12 minutes. The pain experienced does not differ between day case administration and outpatient administration of GYNECARE THERMACHOICE® III with most women describing the pain as absent or moderate⁶.

Outpatient GYNECARE THERMACHOICE® offers several benefits over day case GYNECARE THERMACHOICE®, including avoidance of general anaesthesia and its associated risks, less time in hospital and a quicker recovery period. It further removes the need for and costs of, an anaesthetist, an operating department assistant, operating theatre and hospital beds.

This clinical data does further highlight that GYNECARE THERMACHOICE® III can in fact be administered successfully in an outpatient setting as it is a quick and simple procedure that does not require special expertise for setting up this service in established outpatient hysteroscopy clinics. In fact, the convenience of this procedure allows for immediate ambulatory therapy that not only benefits patients in terms of an effective treatment but one that also reduces morbidity means often associated with general anaesthesia and high risk groups.

^{References:

1.Adapted from Gurtcheff SE Sharp HT. "Complications Associated with Global Endometrial Ablation: The Utility of the MAUDE Database." Obstet Gynecol. 2003; 102:1278-1282.

2.Weisberg M. Comment on "Complications Associated with Global Endometrial Ablation: The Utility of the MAUDE Database." Obstet Gynecol. 2004 May; 103 (5 Pt1):995-996.

3.Clark, T.J., Gupta, J.K. 2004. Outpatient thermal balloon ablation of the endometrium. Fertility and Stability, Vol 82, No.5.

4.Amso N, et al. Uterine endometrial thermal balloon therapy for the treatment of Menorrhagia: long term multicentre follow-up study. 2003. Human Reproduction, Vol.18, No.5, pp. 1082-1087.

5.Badia C.D., Nyirjesy, P., Atogho, A. Endometrial ablation devices: review of a manufacturer and user facility device experience database. Journal of minimally invasive gynecology (2007), 14, 436-441.

6. Marsh, F., Thewlis, J., Duffy, S. Randomised controlled trial comparing GYNECARE THERMACHOICE III in the outpatient versus daycase setting. 2006. American society for reproductive medicine, Fertility and Sterility.}

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Gynecare Thermachoice | Endometrial Ablation | Balloon Device

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