Breast implant related illnesses
Breast implants are medical devices used for breast augmentation and reconstruction. While many women undergo these procedures successfully each year, it’s essential to understand the associated risks and discuss these with the plastic surgeon.
In New Zealand, it is required that all medical implants undergo rigorous initial testing to ensure safety and effectiveness. There is also ongoing monitoring which includes reviewing emerging safety data and communicating with patients and physicians as new risks emerge.
Silicone breast implants have been extensively tested around the world and have been shown to be safe and have no link with breast cancer or connective tissue disorders (which were concerns in the past). Although some women with implants may have experienced health problems such as connective tissue diseases (such as lupus and rheumatoid arthritis), trouble breastfeeding, or reproductive problems, current evidence does not support an association between breast implants and these conditions.
While most women with breast implants experience no serious issues, it is crucial to be aware of potential risks, including Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), Breast Implant-Associated Squamous Cell Carcinoma (BIA-SCC), and systemic symptoms known as Breast Implant Illness (BII).
Your specilaist plastic surgeon will discuss the risk of these conditions, along with other relevant information, to ensure informed decision-making when considering breast implant surgery. Be aware that some conditions have only recently become recognised entities by the medical profession. As such, for patients with older implants, even well performed informed consent of the time justifiably may not have involved a discussion of these diseases.
In conclusion, while breast implants are generally very safe, there can be specific concerns raised by changes in the breasts or changes to your health. Alternatively, some patients may have concerns about older implants which may have been used prior to our current level of understanding of breast implant related conditions. We strongly encourage patients to seek professional advice from their Plastic Reconstructive Surgeon so that a fully informed assessment can be made.
BIA-ALCL is not a breast cancer or cancer of the breast tissue; it is a lymphoma, a cancer of immune cells.
The current lifetime risk of BIA-ALCL is estimated to be 1:3817 – 1:30,000 for women with textured implants, based upon current confirmed cases and textured implant sales data over the past two decades. However, the exact number of cases remains difficult to determine due to due lack of global breast implant sales data.
Symptoms include unexplained breast enlargement, asymmetry or onset of pain. Early recognition of such symptoms is essential for timely medical evaluation, as early diagnosis is crucial for successful treatment. This may involve surgery, chemotherapy, radiation therapy, or other specialist treatment specific to individual cases.
BIA-SCC, a rare but potentially aggressive tumour, also occurs in the scar tissue around breast implants. Currently, we aware of so few reported cases of BIA-SCC that it is not possible to determine what factors increase patient risk.
Symptoms of BIA-SCC resemble those of BIA-ALCL (unexplained breast enlargement, asymmetry, pain) and require prompt medical evaluation. Diagnostic tests may include imaging and biopsy to confirm the diagnosis and guide treatment decisions.
Treatment for BIA-SCC typically involves surgery to remove the implant and surrounding scar tissue, with additional therapies as needed based on disease stage and spread.
BII is not a breast cancer. Breast Implant Illness (BII) is a term used to attribute multiple symptoms and breast implants. These symptoms are numerous, and can include (but are not limited to) fatigue, a feeling of brain fog or inability to concentrate, depression or anxiety, pain elsewhere in the body, dry mouth or eyes, headaches, skin problems, gastrointestinal problems, hair loss, and weight changes. It is important to understand, there is no test or imaging that can confirm breast implant illness. Diagnosis can be challenging, and thorough evaluation by a physician is recommended.
While some published series have observed overall symptomatic improvement after breast implant removal, there have not been any concrete or evidence-based studies or peer-reviewed data concluding a recognised disease entity of “silicone implant illness.” Research is ongoing to define the best treatment for patients with BII.
Patients who are concerned about BII should consult with their plastic surgeon, who can provide advice. Ultimately, the decision to obtain, keep, or remove breast implants is the choice of the patient.
Rupture is a tearing in the outer shell of a breast implant. The symptoms may include a change in breast size or shape, increasing pain, or even nothing. This is because different implants have different designs and materials within. Rupture can happen as a result of trauma (eg. direct blow, seat belt impact in a car accident) but implants can also simply wear out over time – they are not lifetime devices. Depending on the implant, manufacturers will recommend removal or replacement after 10-15 years in the body.
There are no specific recommendations in New Zealand about regular investigations to monitor for implant rupture, a cracking in the outer surface of the implant. In the USA, the FDA recommends screening breast implants with MRI or ultrasound five to six years after silicone implant placement, and every two to three years thereafter. Routine screenings help verify implant integrity and detect complications such as rupture or leakage, even in the absence of symptoms.
The New Zealand Association of Plastic Surgeons, Te Kāhui Whakamōhou Kiri, has worked with MedicAlert to develop the New Zealand Breast Device Registry (NZBDR) – Te Rēhita Taputapu Uma o Aotearoa. Development of the Registry was completed in 2024 and is currently undergoing a pilot trial at Counties Manukau Hospital and Wellington Plastic Surgery Institute. On completion of the pilot trial, the adoption of the registry will be rollout throughout the county.
The Registry will provide a comprehensive database of implanted breast devices to monitor and reduce the risk of adverse outcomes and complications for women with these products. The purpose of the NZBDR is to provide medical information, reporting, device tracking and auditing of complications for the women of New Zealand and their health professionals. This registry will make it possible to trace patients in the event of a product recall or safety concern related to a specific type of implant. For more information on the Registry, visit the NZBDR website.
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