HNY Central Digital Repository - York

Breast Prosthesis Complications

Removal of breast implants is commissioned for the following indications:

• Breast disease OR

• Implants complicated by severe recurrent infections OR

• Implants with grade 4 capsule formation that is associated with severe pain OR

• Implants with capsule formation that interferes with mammography OR

• Intra or extra capsular rupture of silicone gel filled implants OR

• Implant that is a PiP implant

When a patient is eligible for implant removal due to one of the above indications associated with a single implant, bilateral implant removal is commissioned and should be offered.

Patients whose initial procedure was privately funded will be directed back to their private provider. If, however, the patient meets one of the above clinical indications, and the private provider is unable to offer the patient surgery, the patient can be offered referral for breast implant removal funded by the NHS, but not replacement.  

Removal of breast implants due to symptoms termed e.g. on social media, as Breast Implant Illness (BII) or Autoimmune Syndrome Induced by Adjuvants (ASIA), or due to the risk of developing Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is not commissioned.

Replacement of implants is commissioned if patients meet the above criteria for removal and both of the following indications are met:  

• The implant insertion was funded by the NHS AND  

• The original implant insertion was following cancer surgery, trauma or congenital asymmetry 

Breast implants have a limited lifespan and patients should be aware at the time of initial surgery that implants are likely to need replacement and further surgery may be required.  

In the case of implant rupture, severe capsular contracture, recurrent infection, breast disease and BIA-ALCL the benefit of removing an implant outweighs the risk of keeping the implant in place.  

It is accepted that the NHS has a duty of care to patients who require their implant to be removed for a listed clinical indication, but only if their private provider is unable to offer this care. As the NHS does not routinely fund breast implants for cosmetic reasons, removal but not replacement is considered appropriate in these cases. 

Concerns have been expressed about the potential side effects of breast implants including the development of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Breast Implant Illness (BII) or Autoimmune Syndrome Induced by Adjuvants (ASIA). However, the consensus from the available evidence is that these potential side effects do not justify the routine removal of breast implants at present.  

BIA-ALCL is uncommon and in the UK is estimated to be 1 per 20,000 implants sold. The most recent guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) states that based on the current available evidence people with breast implants do not need to have them removed in the absence of diagnosis of ALCL. The MHRA states this position is consistent with international regulators and they will continue to collect data on ALCL in patients with breast implants and review the guidance in light of any new evidence.  

BII/ASIA is used by some to describe a constellation of symptoms felt to be associated with their breast implants. However, BII/ASIA is not a WHO recognised disease. The MHRA states there is no single disease which could explain the reported symptoms and it is currently unknown whether there is a link between breast implants and the reported symptoms.

Breast enlargement (implants) - NHS (www.nhs.uk)

What complications can occur | BAPRAS

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) - GOV.UK (www.gov.uk)

Joint statement from ABS, BAAPS and BAPRAS Advice regarding Breast Implant safety | The British Association of Aesthetic Plastic Surgeons

Symptoms sometimes referred to as Breast Implant Illness - GOV.UK (www.gov.uk)