Potential risks

As with any surgery, there are potential risks of complications. We've collected information that patients should understand before undergoing the treatments offered by Minerva Surgical®. Talk to your doctor to learn more.

Minerva ES® Endometrial Ablation System

Genesys® HTA Endometrial Ablation System

Symphion® Operative Hysteroscopy System

The Resectr™ Tissue Resection Device

 

Information for patients considering the Minerva ES® Endometrial Ablation System.

If you are a Healthcare Provider, please view the Instructions for Use here.

What is the Minerva ES Endometrial Ablation System?
Minerva ES is a system that physicians use to perform an endometrial ablation.  Endometrial ablation is a one-time treatment that reduces or eliminates bleeding and clots due to AUB-E. The treatment involves a minimally invasive method of removing the endometrium lining in the uterine cavity. The endometrial lining of the uterine cavity is what you shed during your period.

What are the Minerva ES Indications for Use?
The Minerva Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with AUB (abnormal uterine bleeding) due to benign causes for whom childbearing is complete.

How to Decide if the Minerva Treatment is Right for You? 
The first step is to talk to your doctor about your symptoms. Your doctor will do a series of tests to determine the cause of your symptoms. Heavy bleeding by itself is not a disease, but it is a symptom of several possible medical conditions, including AUB. Using ultrasound and/or hysteroscopy (methods used by doctors to see your uterus), along with other tests, your doctor will determine the cause of your heavy periods. 

What are the Risks of the Minerva ES Treatment?
With any procedure, there are risks related to the treatment and to the anesthesia used during the treatment. Your doctor will talk to you about the risks of the Minerva treatment and will give you details about your individual situation. It is important for you to know the risks of the Minerva treatment. 

The risks associated with the Minerva ES treatment include, but are not limited to:

  • Injury (e.g., tear) of the uterus. 
  • Injury to organs in the abdomen (e.g., bowel or bladder). 
  • Potential complication (e.g., new pain during menstrual cycles) in women who have previously had a tubal ligation. 
  • Serious pregnancy complications for both mother and unborn baby. The Minerva procedure does not protect women from future pregnancy. Patients will still need to use contraception or undergo a permanent sterilization procedure. 
  • Life-threatening infection. Patients should contact their doctor if they develop any of the following:
    • Fever higher than 100.4 °F 
    • Abdominal pain that becomes worse and does not get better by pain medication given by the doctor or by ibuprofen 
    • Nausea 
    • Vomiting 
    • Bowel or bladder problems 
    • Vaginal discharge that has a foul smell 
  • Other risks and complications leading to serious injury or death. Undergoing an endometrial ablation procedure may make it more difficult to diagnose endometrial cancer in the future.

 

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Information for patients considering the Genesys® HTA System.

If you are a Healthcare Provider, please view the Instructions for Use here.

What is the Genesys HTA System?
Genesys HTA is a system that physicians use to perform an endometrial ablation.  Endometrial ablation is a one-time treatment that reduces or eliminates bleeding and clots due to AUB-E. The treatment involves a minimally invasive method of removing the endometrium lining of the uterine cavity. The endometrial lining of the uterine cavity is what you shed during your period.

What are the Genesys HTA Indications for Use?
The Genesys HTA System is a hysteroscopic thermal ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with AUB (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

How to Decide if the Genesys HTA Treatment is Right for You? 
The first step is to talk to your doctor about your symptoms. Your doctor will do a series of tests to determine the cause of your symptoms. Excessive bleeding by itself is not a disease, but it is a symptom of several possible medical conditions, including AUB. Using ultrasound and/or hysteroscopy (methods used by doctors to see your uterus), along with other tests, your doctor will find the cause of your heavy periods. 

What are the Risks of the Genesys HTA Treatment?
With any procedure, there are risks related to the treatment and to the anesthesia used during the treatment. Your doctor will talk to you about the risks of the Genesys HTA treatment and will give you details about your individual situation. It is important for you to know the risks of the Genesys HTA treatment. 

The risks associated with the Genesys HTA treatment include, but are not limited to:

  • Injury (e.g., tear) of the uterus
  • Injury to organs in the abdomen (e.g., bowel or bladder)
  • Potential complication (e.g., new pain during menstrual cycles) in women who have previously had a tubal ligation
  • Serious pregnancy complications for both mother and unborn baby. The Genesys HTA procedure does not protect women from future pregnancy. Patients will still need to use contraception or undergo a permanent sterilization procedure.
  • Life-threatening infection. Patients should contact their doctor if they develop any of the following:
    • Fever higher than 100.4 °F 
    • Abdominal pain that becomes worse and does not get better by pain medication given by the doctor or by ibuprofen 
    • Nausea 
    • Vomiting 
    • Bowel or bladder problems 
    • Vaginal discharge that has a foul smell
    • Potential for heated fluid to leak out of the uterus during the procedure and result in a burn to the vagina or surrounding areas. In very rare cases, it may be necessary to seek specialized care from a burn center.
  • Other risks and complications leading to serious injury or death. Undergoing an endometrial ablation procedure may make it more difficult to diagnose endometrial cancer in the future.

 

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Information for patients considering the Symphion System® for hysteroscopic myomectomy

If you are a Healthcare Provider, please view the Instructions for Use here.

What is the Symphion System?
Symphion is a system that physicians use to perform a hysteroscopic myomectomy. Hysteroscopic myomectomy involves passing a thin, lighted instrument through the vagina and cervix, and into the uterus to locate and remove fibroids or polyps on the inner wall of the uterine cavity.

What are the Symphion System Indications for Use?
The Symphion System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed-loop recirculation of filtered distension fluid.  It is also intended for cutting and coagulation of uterine tissue such as intrauterine fibroids and using a bipolar resecting device.

How to decide if the Symphion System is Right for You? 
The first step is to talk to your doctor about your symptoms. Your doctor will do a series of tests to determine the cause of your symptoms. Using ultrasound and/or hysteroscopy (methods used by doctors to see your uterus), along with other tests, your doctor will determine if you have uterine fibroids and/or polyps that need to be removed. 

What are the Risks associated with the Symphion System?
With any surgery, there are risks related to the treatment and to the anesthesia used during the procedure. Your doctor will talk to you about the risks of hysteroscopic myomectomy and/or polypectomy and will give you details about your individual situation. It is important for you to know the risks of the Symphion System. 

The risks associated with the Symphion System include, but are not limited to:

  • While complications are rare, some women experience cramping, mild pain or nausea following the procedure. 
  • Other more serious risks such as bleeding, infection and surgical complications are also possible.

 

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Information for patients considering the Resectr™ Tissue Removal Device for hysteroscopic polypectomy

If you are a Healthcare Provider, please view the Instructions for Use here.

What is the Resectr Tissue Removal Device?
The Resectr device is used in a minimally invasive surgical procedure known as polypectomy or hysteroscopic tissue removal. During this guided hysteroscopic procedure, your doctor is able to both see and treat polyps that may need to be removed. 

What are the Resectr Indications for Use?
The Resectr is a single-use, non-powered, hand-held, and hand-manipulated manual surgical instrument intended to be used in various hysteroscopic surgical procedures to dissect, resect, and/or remove tissue.

How to decide if the Resectr Tissue Resection Device is Right for You? 
The first step is to talk to your doctor about your symptoms. Your doctor will do a series of tests to determine the cause of your symptoms. Using ultrasound and/or hysteroscopy (methods used by doctors to see your uterus), along with other tests, your doctor will determine if you have uterine polyps that need to be removed. 

What are the Risks associated with the Resectr Tissue Resection Device?
With any surgery, there are risks related to the treatment and to the anesthesia used during the procedure. Your doctor will talk to you about the risks of hysteroscopic polypectomy and will give you details about your individual situation. It is important for you to know the risks of the Resectr Device. 

The risks associated with the Resectr Tissue Resection Device include, but are not limited to:

  • While complications of hysteroscopic polypectomy are rare, some women experience cramping, mild pain, or nausea following the procedure. 
  • Other more serious risks are possible during surgical procedures, such as uterine perforation, bleeding, pelvic infection, and other surgical complications.

If you have any questions or concerns about any of the risks found on this page, consult your doctor.

 

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