Breast implant illness

What breast implant illness is

A number of patients and clinicians use the terms breast implant illness (BII) and systemic symptoms associated with breast implants (SSBI) to refer to a range of symptoms that may be experienced after breast implant surgery.

The symptoms are diverse, and could include:

• fatigue
• brain fog
• memory loss
• rashes
• hair loss
• joint pain
• muscle pain.

Many reports of possible BII include more than one symptom. The symptoms experienced by people can have an impact on their overall health and well-being.

However, based on information available in the reports and scientific literature, it is not currently known whether breast implants cause the various symptoms. This is partly because the various symptoms can be caused by a wide range of factors that are unrelated to breast implants, such as a person’s medical history or environment. While current scientific evidence is limited, ongoing studies are underway to shed light on its development and to better understand any potential association with breast implants.

Implants and BII

Symptoms are not restricted to particular implants.

Symptoms of BII have been reported by patients with any type of breast implant, including silicone, saline, smooth, textured, or tear-drop, regardless of whether the implants are ruptured, leaking, or intact. Until further research can define the relationship between breast implants and BII, it is important for patients to recognise and be aware of the associated symptoms.

Information for consumers

If you have symptoms that are similar to those reported for BII, talk to your healthcare professional or surgeon about your symptoms, possible causes, and possible treatments. At present, there is insufficient evidence to support a recommendation to remove implants to improve quality of life. This is because the association of the symptoms with breast implants is still being investigated. It is important that you are investigated for other causes of these symptoms such as inflammatory disease, vitamin/iron deficiency and/or chronic infection.

If you have breast implants

• Check your breasts regularly for any changes
• Be aware of the risks and benefits of breast implants
• Be aware of potential symptoms of BII, such as fatigue, brain fog, memory loss, rashes, hair loss, joint pain and muscle pain
• Discuss any signs or symptoms with your healthcare professional.

If you're considering breast implants

• Get information about the risks and benefits of breast implants
• Discuss the risks and benefits with a healthcare professional.

Generally, breast implants are not lifetime devices, regardless of any other complications. Common reasons for removal are contracture, rippling, movement or rupture of the implant.

If you have any other questions or concerns, we encourage you to talk to your healthcare professional or surgeon.

Information for healthcare professionals

As part of obtaining informed consent, you should talk to the patient about BII. It is important for patients to know about the potential risks of breast implants. They should also be provided with educational material to read and consider prior to making a decision about their surgery.

After implantation, patients should be provided with the:

• name and type of implant
• procedure performed
• breast implant manufacturer's labelling
• patient information leaflet, and
• the patient-specific implant card.
• advice about the need for ongoing surveillance for both breast cancer and breast implants.

As with other conditions related to breast implants, patients with implants should know the common presenting symptoms of BII.

Information for sponsors

It is an automatic condition of inclusion under 5.7 of the Therapeutic Goods (Medical Devices) Regulations 2002 that sponsors of a medical device report adverse events or near adverse events to the TGA Incident Reporting and Investigation Scheme (IRIS).

Adverse event reporting allows the TGA to monitor medical device use, monitor their performance in the real world and identify trends that may indicate emerging safety and performance issues. These activities allow the TGA to take appropriate regulatory action to address these issues.

Sponsors should be recording and reporting any adverse event related to breast implants, including incidences with symptoms or adverse events of unknown cause.

Report problems

We monitor the safety of medical devices in Australia, including breast implants. If you experience a problem or side effect following a breast implant procedure, report it to us.

We strongly encourage patients and healthcare professionals to report any adverse events associated with breast implants.

We take a proactive approach in monitoring the potential impacts of all types of breast implants. We aim to minimise implant related hazards, detect any adverse effects early, and take regulatory action quickly if needed. Our breast implant risk management framework is published on our website.