Response to release of surgical mesh report

The Office of the Health and Disability Commissioner acknowledged the release today of the report detailing the harm caused by surgical mesh and the experiences of those people at the centre of the report.

Commissioner Anthony Hill said he recognised the pain and trauma experienced by the people who had shared their stories with researchers.

"The restorative process is a valuable one and I am pleased to see the Ministry of Health and other agencies committing to actions to address the harms and needs of those affected. I will continue to actively monitor the progress made," Anthony Hill said.

"HDC will take on the feedback we have heard in the report about our complaints process. Last year the National Advocacy Service, which is funded by HDC, substantially improved its website to make contacting an advocate even easier. In response to this report, HDC will be looking at ways in which we can further promote this excellent service."

Anthony Hill said the report raised a number of issues around informed consent, the foundation of all medical treatment.

"Informed consent is at the heart of the Code of Health and Disability Services Consumer Rights. Information about the options available to patients, including an assessment of the expected risks, side effects, benefits, and costs of each option is an essential part of the informed consent process. It is incumbent on all health care providers to ensure that they are communicating this information to patients in a way that enables that individual patient to understand," Anthony Hill said. "It is good to see a commitment to using credentialling and training to support these principles to be embedded into everyday clinical practice."

As an impartial, independent and quasi-judicial watchdog HDC assesses each complaint it receives carefully and resolves it in the most appropriate manner, bearing in mind the issues raised and the evidence available. When considering individual complaints about the use of surgical mesh products, HDC assesses whether, given the information that was available about the risks and benefits of surgical mesh at the time the surgery occurred, the standard of care and information provided to patients was appropriate. The level of knowledge in regards to the risks and benefits of surgical mesh has changed over time, and a number of complaints HDC received about the use of surgical mesh products related to procedures undertaken a number of years earlier.

Anthony Hill said he remained concerned about the wider systemic issues with the use of these products, including the ease with which mesh products came onto the market, the information provided to patients about these products and the quality of care.

"I am concerned that there are gaps in New Zealand's regulatory design that may allow such an event to occur again. It is important that work to establish a regulatory scheme for medical devices is prioritised to protect against this. I note that the Government is currently working on a Therapeutic Products Bill which would help to address issues around the ease with which such devices come on the market and I will be following up with the Ministry around the action they are taking,” Anthony Hill said.

Ends

 

Overview of HDC's complaint process


HDC's preliminary assessment process is thorough and can involve a number of steps, including: asking the provider to respond to the complaint and the concerns raised; seeking independent clinical advice about the standard of care; and asking the complainant and provider to comment on any information gathered. HDC may also seek information from other agencies such as the Ministry of Health and ACC. HDC listens to every side of the argument, weighs up the evidence and makes an impartial decision.

HDC has a wide discretion as to what action is taken after the preliminary assessment process is complete, including:

  • Referring the complaint to the Advocacy Service or to the provider for direct resolution between the parties. Both the Advocacy Service and providers are required to report back to HDC on the outcome of these referrals, ensuring that people’s concerns have been addressed appropriately.
  • Referring the complaint to other agencies where the issues raised are more appropriately dealt with by that agency e.g. issues related to a provider’s fitness to practice are often more appropriately dealt with by their regulatory authority.
  • The Commissioner may take no further action on a complaint where the preliminary assessment indicates that a provider’s actions were reasonable in the circumstances, there are evidential issues which cannot be resolved, or the issues in the complaint have been appropriately addressed by other means. These decisions can often be accompanied by recommendations for change or educational comment designed to effect positive change to the health care system. HDC then follows up with the provider to ensure they have complied with any recommendations made. Providers are also often asked to evaluate the effectiveness of any changes made.
  • The Commissioner may decide to conduct a formal investigation of a complaint which can result in the provider being found in breach of the Code. The general focus of investigations continues to be on more serious departures from accepted standards of care, allegations of breaches of ethical boundaries, public safety concerns, and where there is potential for significant positive change as a result. HDC’s powers to investigate are used where they can have greatest effect.

Complainants receive a written explanation of any such decisions and actions taken by the Commissioner. Where a decision to take no further action has been made, the complainant will often be given an opportunity to comment on the Commissioner’s findings, including any proposed recommendations, before a final decision is made.

Every complaint is an opportunity to learn, and the motivation for many complainants is change to services so that what happened to them does not happen to someone else. HDC makes many recommendations for change or educational comments in response to a number of complaints (e.g. 448 complaints in 2018/19), and in this way holds the provider and system to account for learning and taking preventative action, as well as protecting consumer’s rights. HDC’s recommendations have a high compliance rate, with 99.3% of recommendations being complied with in 2018/19.