NSW Guidelines for Breast Implant Surgery

NSW Health has published a formal toolkit for the management of breast implants, which prioritises patient safety and protection.

The new guidelines aim to:

• inform surgeons who insert breast implants of best practice when caring for patients with breast implants or considering implants; and
• change the way that care is delivered.

The 23-page Toolkit was produced by the Surgical Services Taskforce of the Agency for Clinical Innovation (ACI) – NSW’s lead agency for innovation in clinical care.

ACI brings ‘consumers, clinicians and healthcare managers together to support the design, assessment and implementation of clinical innovations across the NSW public health system to change the way that care is delivered’.

The guidelines were developed following the Therapeutic Goods Administration (TGA) banning the use of three breast implants in late 2020 over links to a rare cancer.

Professor Anand Deva, head of plastic and reconstructive surgery at  Macquarie University and co-author of the guidelines, told The Sydney Morning Herald: ‘We have seen class actions, breast implant illness and women dealing with ongoing pain.

‘These guidelines put a bottom line on safety. Doctors need to get proper, educated, informed consent from patients and make sure women have regular check-ups so problems are picked up early,’ he said. ‘Too many patients regret implants.’

Co-author Professor Mark Ashton, former president of the Australian Society of Plastic Surgeons, added that the NSW guidelines would pave the way for the national regulator

‘to assess whether doctors are operating within accepted standards of care’.

He noted: ‘It is the first time any state has had a comprehensive breast implant guide available in a public document that clearly states what we expect medical practitioners to do, and how we expect doctors to behave.

‘It helps patients understand what they should be asking when they go for that first consultation.’

Professor Ashton said it was critically important patients are aware of the risks of implants, with the Toolkit calling for:

• a minimum of two in-person consultations with patients;
• pre- and post-operation ultrasounds and mammograms;
• cooling-off periods;
• reporting of implants and adverse events into the Australian Breast Device Registry; and
• ongoing surveillance of breast implants after surgery.

Professor Ashton emphasised that one of the biggest issues in the cosmetic surgery industry is the lack of transparency about individual medical practitioners and their qualifications: ‘Anyone with a medical degree or a GP or dermatologist can call themselves a cosmetic surgeon.

‘There is no transparency that some doctors are just unskilled in certain types of operations. We hope guidelines like these will be implemented Australia-wide.’

The Toolkit warns patients that ‘by proceeding with implant surgery, you are also required to undergo regular follow-up with your treating doctor for clinical and radiological assessment of your breast implants.’

It emphasises: ‘You will require routine and regular surveillance for as long as you have breast implants.’

In addition, the Toolkit advises all potential implant patients: ‘It is strongly recommended that you register your device with the Australian Breast Device Registry.

‘This will allow tracking of outcomes and safety and will allow notification of any important information on the safety of your breast implants to you directly.

‘Please ask your doctor to register your device at the time of surgery.’

The Toolkit also provides a detailed checklist for completed clinician/patient discussion – including sample ‘signature and confirmation’ clauses for both patients and doctors to sign and date.

Professor Ashton told The Sydney Morning Herald that similar guidelines are being developed for liposuction procedures in Victoria.

But he also warned: ‘Guidelines are helpful, but they aren’t legally enforceable. We need the Australian Health Practitioner Regulation Agency (AHPRA) to have real teeth to punish outliers in cosmetic care who are performing surgery outside the guidelines of accepted medical care.’

3 Different Clinical Scenarios

The Toolkit considers three specific clinical scenarios:

1. Patients who present for breast reconstruction following cancer treatment or prophylactic mastectomy.
2. Patients who present for cosmetic augmentation of breasts.
3. Patients who have breast implants ‘in situ’ and who are concerned about their future risk of adverse events.

Implant-based breast reconstruction

The Toolkit lists detailed steps that are recommended for pre, intra and post-operative management of implant-based breast reconstruction.

• Pre-operative work-up: 12 steps – from ‘outline all options’ through to ‘offer a second consultation’.
• Operative procedure: 12 steps – from ‘reconstructive procedure must be performed in a fully licensed and accredited facility with established access to high dependency care’ through to ‘communicate operative information, implant information and clinical history to the patient’s primary care provider’.
• Post-operative care: 4 steps – from ‘schedule inspection of the surgical site’ through to ‘discuss signs and symptoms that should prompt medical review’.

Cosmetic breast augmentation

• The Toolkit similarly lists detailed steps that are recommended
  for pre, intra and post-operative management of cosmetic breast augmentation.
  Pre-operative work up: 15 steps – from ‘present clinical credentials and experience’ through to ‘ensure a second face-to-face consultation prior to proceeding’.
• Operative procedure: 10 steps – from ‘procedure must be performed in a fully licensed accredited facility’ through to ‘communicate operative information, implant information and clinical history to the patient’s primary care provider’.
• Post-operative care: 6 steps – from ‘schedule an inspection of the surgical site’ through to ‘initiate and incorporate an ongoing screening and surveillance program for breast cancer’.

Assessment of patients with breast implants in situ

The Toolkit also lists detailed steps recommended for patients with breast implants in situ, including consultation and pre, intra and post- operative management of explant surgery, if the patient proceeds to explant surgery.

• Consultation: 9 steps – from ‘complete a thorough patient history’ through to ‘discuss the risks and benefits of implant removal, partial capsulectomy and total capsulectomy’.
• Pre-operative work up, explant surgery: 8 steps – from ‘present clinical credentials and experience’ through to ‘ensure a second face-to-face consultation prior to proceeding’.
• Operative procedure, explant surgery: 12 steps – from ‘explant surgery procedure must be performed in a fully licensed accredited facility’ through to ‘communicate operative and clinical history to the patient’s primary care physician’.
• Post-operative care, explant surgery: 4 steps – from ‘schedule an inspection of the surgical
  site’ through to ‘consider obtaining a baseline mammogram +/- breast ultrasound one year after explant surgery’.

Breast Implant Risks

The Toolkit also highlights the risks of breast implant surgery in 3 main areas.

Changes to your breast:

• Breast pain
• Skin, nipple or areola loss of sensitivity
• Asymmetry
• Impact of weight change to size and shape of breasts
• Impact of pregnancy and breast feeding on the size, shape and position of breasts
• Infection which may require removal of implant
• Swelling
• Scarring
• Fluid collection (seroma)
• Bleeding and hematoma
• Loss of skin and nipple
• Inability to breastfeed
• Chronic pain

Changes to the implant:

• Rupture, including silent rupture
• Leaking of silicone and formation of painful lumps in your breast
• Visibility and rippling of the implant
• Capsular contracture, where a hardening of tissue around the implant can cause pain, deformity and may require revision surgery or implant removal
• Mobility of the implant
• Malposition or displacement of the implant causing deformity, eg, double bubble
  Breast implant associated anaplastic large cell lymphoma (with textured devices)

Possible association of systemic symptoms

Some women report ‘a variety of systemic symptoms including joint pain, fatigue and ‘brain fog’, which has been labelled as breast implant illness’.

While the causes of these symptoms ‘remain unclear, more research is needed to further define the cause(s) and outcomes, and to determine whether these symptoms resolve following removal of implants’. AMP

Toolkit’s 6 Founding Principles

The founding principles that shape the Toolkit’s guidelines are:

1. Empowerment of patients and encouragement of shared and protected decision-making with, where possible, multiple time points for discussion.
2. Transparency in potential personal and commercial conflicts of interest.
3. Education of patients on risks, benefits and alternatives of breast reconstruction procedures.
4. Management of patient uncertainty and anxiety.
5. Providing options and choice for a variety of treatments.
6. Outlining ongoing duty of care and post-operative surveillance.

NSW Health has also published the ‘Consent to Medical and Healthcare Treatment Manual’
on informed consent procedures relating to healthcare treatment – and emphasises that this is a supporting document for this Toolkit.

The Toolkit guidelines note that ‘where possible, patients should be encouraged to attend consultations with a support person or persons, to ensure there are multiple opportunities to process information and to provide advocacy and support’.

The guidelines add it is also important that any complications or adverse events associated with breast implant procedures are recorded and reported appropriately. This includes compliance with ‘Policy Directive PD2020_047: Incident Management’ – the TGA’s online module for adverse event reporting and local hospital or facility policies.

Patient ‘Consent’ Checklist

The Toolkit advises potential patients that ‘before you make a decision about whether to proceed with breast implant surgery, you must ensure you are familiar with the risks associated with using these devices.

‘The risks are reported in clinical trials, scientific literature and patient-reported outcomes. You should take the time to read through this information – and take the opportunity return to your doctor, if necessary, to discuss these further before you proceed.’

In addition – and most importantly – ‘you should have been given a number of options for treatment, including treatment without the use of implants, by your doctor and they should outline clear reasons why one or more of these treatment options have been recommended for you.’

It is also important that ‘you ask for help if you need assistance reading and understanding this information’.

As well as this information, ‘your doctor should also provide you with an information booklet or brochure, provided by the manufacturer of the implants to be used in your surgery, which outlines the instructions for their use’.

The Toolkit highlights the warning: ‘It’s important to remember that breast implants are not lifetime devices.

‘They are associated with a range of risks that can often require further surgery to your breasts.’