Asherman Syndrome and risks associated with medical devices
Asherman Syndrome is a uterine condition linked to intrauterine scarring that can affect fertility and menstruation, with this page outlining risks, symptoms, and the TGA’s regulatory role and guidance.
We have received queries in relation to Asherman Syndrome.
Asherman Syndrome is a condition where adhesions and significant scar tissue may form inside the uterus. This scarring can cause serious damage to the function of the uterus, such as difficulty becoming pregnant, repeated miscarriages, or significant changes to menstrual periods.
Asherman Syndrome can be difficult to diagnose and is sometimes recognised only after significant symptoms have developed.
The TGA is responsible for regulating medical devices. Regulation and/or guidance relating to clinical practice is beyond the role of the TGA.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) is responsible for clinical guidance relating to treatment, management and diagnosis of Asherman Syndrome.
Known associations with Asherman Syndrome
In some cases, Asherman Syndrome has been found to develop following intrauterine surgical procedures, including dilation and curettage (D&C), where injury to the uterine lining (endometrium) may occur.
Procedures such as D&C may be performed following miscarriage, for removal of pregnancy tissue, to remove retained placenta after childbirth, or for other gynaecological reasons such as endometrial biopsies or surgical termination of pregnancy.
There are a number of techniques for these procedures, and the use of curettes, including sharp curettes, particularly during a D&C has been identified as one of the risk factors associated with development of intrauterine adhesions.
Other causes and risk factors can include infection in the uterus, particularly at the time of childbirth or miscarriage, uterine tuberculosis, and other uterine surgeries such as removal of fibroids, or polyps and thickened lining of uterus.
Sometimes, no cause can be identified for Asherman Syndrome.
Symptoms and impact of Asherman Syndrome
Asherman Syndrome can have serious impacts on women's health.
Symptoms vary. Some women may have no symptoms at all, while others may experience:
- reduced or absent periods
- painful periods
- difficulty becoming pregnant
- recurrent miscarriages
- pelvic pain
- pregnancy complications, such as placental abnormalities, premature delivery, or severe bleeding after birth.
Women suffering from Asherman Syndrome often experience emotional distress due to delayed diagnosis and impact on their reproductive plans. Timely diagnosis, specialist care and psychological support is essential to help manage the broader effects of the condition.
For more see advice from RANZCOG - external site.
Actions
We are aware of reports of women diagnosed with Asherman Syndrome who have a history of a D&C procedures. A range of devices and risk factors have been identified in association with the condition. These include not only sharp metal curettes, but also other devices used within the intrauterine space.
Some reports also describe women having more than one procedure involving the uterus before being diagnosed, or having other conditions, such as infection, that may increase the likelihood of developing Asherman syndrome.
All sponsors of intrauterine sharp curettes included in the Australian Register of Therapeutic Goods (ARTG) have been requested to review their instructions for use (IFU) and product labelling to ensure that the risk of Asherman Syndrome is appropriately addressed.
Our focus is to ensure that the potential risk of developing Asherman Syndrome is outlined by manufacturers, and that clear, accurate information is available to patients and healthcare professionals. This approach supports informed decision-making and promotes safe use of these devices.
Women's Health Products Working Group (WHPWG)
The WHPWG is an important stakeholder committee of the TGA, collaborating with our members to discuss issues relating to the access and regulation of women's health products.
The WHPWG is comprised of representatives from consumer groups, health professionals, industry, academia, and senior officials from the Department of Health, Disability and Ageing.
Asherman Syndrome, its health impacts and outcomes, and the need for improved data collection and collaboration with specialist medical colleges, communities and health professionals about the Syndrome, was discussed at the October 2024, March 2025 and October 2025 WHPWG meetings.
We continue to work with the group to determine any emerging pre-market and post-market issues related to the medical devices to determine the best course of action.
For consumers
Treatment for Asherman Syndrome, if required, is performed by a specialist, who may use a hysteroscope to remove the scar tissue from the uterus.
If you are concerned about changes in your periods, your fertility, or if you have had uterine surgery and are experiencing symptoms, it is important to speak with your doctor or a fertility specialist.
Support is available, free through Medicare Mental Health services - external site, and connecting with peer groups or counselling services can help you manage the emotional impact of diagnosis and treatment.
For health professionals
RANZCOG have published information on Asherman Syndrome - external site and caution against sharp curettage - external site for management of incomplete and missed miscarriage up to 14 weeks due to an association with increased risk of intrauterine adhesions, where possible.
There are also various clinical guidelines including from the World Health Organisation - external site (WHO), and the Royal College of Obstetricians & Gynaecologists - external site that indicate an increased likelihood of developing intrauterine adhesions or Asherman Syndrome with sharp curette usage, and recommend not to use these devices in D&C procedures (where possible) due to increased risk of bleeding, pain and uterine perforation.
It is important for healthcare professionals to provide sufficient information about these devices to enable informed educated consent by their patients.
The ACSQHC has published a range of resources related to informed consent - external site and shared decision-making
For sponsors
Sponsors should ensure that all devices supplied for uterine interventions have clear, evidence-based IFUs. This must include the risks of intrauterine adhesions if relevant.
Sponsors have an ongoing obligation to report adverse events and should continue to ensure adverse events related to uterine intervention devices are recorded and reported to the TGA.
Report problems
Patient safety is a priority for the TGA. Patients are encouraged to report all adverse events to the TGA.
Consumers and healthcare professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme - external site (IRIS).
We cannot give advice about an individual's medical condition.
You are strongly encouraged to talk with a healthcare professional if you are concerned about the use of particular devices, procedure outcomes, risks, possible complications, and possible alternatives.