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n/a
Document type
Clinical policy
Place
Hertfordshire and West Essex ICB
Output type
Clinical Policies & Evidence-based Interventions
Document
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Breast Prosthesis Removal

Policy:

This is a national Evidence Based Intervention policy formally adopted by Hertfordshire and West Essex Integrated Care Board. Please see https://ebi.aomrc.org.uk/

Breast implants may be inserted during reconstructive surgery for treatment or prevention of breast cancer or for cosmetic purposes. Surgery to remove a breast implant may be used to treat the complications of breast implants inserted for reconstructive or cosmetic purposes.

Recommendation:

This guidance applies to those 18 years and over.

This proposal does not cover the following:

  • Gender reassignment surgery

  • Implants inserted following surgery for breast cancer or breast cancer prevention performed under the NHS. In these cases, please refer to the Association of Breast Surgery (ABS) Guidance for the Commissioning of Oncoplastic Breast Surgery.

Surgery to remove breast implants should only be considered for the following clinical indications:

  • After implant leakage or rupture

    OR

  • There is severe capsular contracture (grade III/IV on the Baker classification). This will need to be confirmed by a specialist opinion.

    OR
  • Implants are complicated by recurrent implant infection or seroma

    OR
  • The patient develops Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Pre and postoperative photographs MUST be recorded for audit purposes. All eligible patients MUST be entered into the Breast and Cosmetic Implant Registry (BCIR) for audit purposes.

Patients whose initial procedure was privately funded should seek assurance from their private provider in the first instance.

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 an NHS referral for breast implant removal but not for replacement.

Where a patient is eligible for implant removal due to a problem associated with a single implant, bilateral implant removal should be offered.

Only implant removal should be performed, and no other subsequent cosmetic procedure e.g. mastopexy.

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

Only patients whose initial procedure was funded by the NHS should be considered for both implant removal and replacement. In line with current guidance, patients eligible to have their implant replaced must be informed of the potential risk of BIA-ALCL.

As per guidance NG180 from the National Institute for Health and Care Excellence (NICE), discuss lifestyle modifications with people having surgery — for example stopping smoking and reducing alcohol consumption — in order to reduce the risk of post-operative complications. See NICE guidance NG180 on Perioperative care in adults for more information.

Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed as per the ICB policy.

Rationale for Recommendation

Patients should be informed 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 commission 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 BIA-ALCL and BII or Autoimmune Syndrome Induced by Adjuvants (ASIA).

The BIA-ALCL is uncommon and in the UK is currently estimated to be 1 per 15,000 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 symptoms 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 World Health Organization 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 health problems.

Patient Information

Information for Patients

Surgery to remove breast implants is only carried out by the NHS in specific situations when criteria are met. All patients should be aware when having implant surgery that due to capsular contracture and less frequently rupture they will need to be replaced at some point.

We recommend using the BRAN principles (Benefits, Risks, Alternatives and do Nothing) when speaking with patients about this.

Further information on patient involvement in EBI can be found at https://ebi.aomrc.org.uk/resources/ebi-patient-information/ This weblink was correct as of 06/01/2025.

Further information can be found at https://ebi.aomrc.org.uk/interventions/breast-prosthesis-removal/ This weblink was correct as of 06/01/2025.

Coding

Admitted Patient Care

WHEN LEFT(Primary_Spell_Procedure,4) IN ('B303', 'B307')
AND (Any_Spell_Diagnosis LIKE '%Z421%')
AND (NOT( Any_Spell_Diagnosis LIKE '%T85[487]%'
OR Any_Spell_Diagnosis LIKE '%N60[0123489]%'
OR Any_Spell_Diagnosis LIKE '%N61%'
OR Any_Spell_Diagnosis LIKE '%N63%'
OR Any_Spell_Diagnosis LIKE '%N64[01234589]%'
OR Any_Spell_Diagnosis LIKE '%C84[6789]%'
OR Any_Spell_Diagnosis LIKE '%Y812%'
)
OR Any_Spell_Diagnosis IS NULL
)
-- Only Elective Activity
AND APCS.Admission_Method NOT LIKE '2%'
-- Age between 18 and 120
AND isnull(APCS.Age_At_Start_of_Spell_SUS,APCS.Der_Age_at_CDS_Activity_Date) between 18 AND 120
THEN '3A_Breast_Prosthesis_Removal'

Exclusions 

WHERE 1=1
-- Cancer Diagnosis Exclusion
AND (Any_Spell_Diagnosis not like '%C[0-9][0-9]%'
AND Any_Spell_Diagnosis not like '%D0%'
AND Any_Spell_Diagnosis not like '%D3[789]%'
AND Any_Spell_Diagnosis not like '%D4[012345678]%'
OR Any_Spell_Diagnosis IS NULL)

-- Private Appointment Exclusion
AND apcs.Administrative_Category<>'02'

Outpatient

WHEN Any_Appointment_Procedure LIKE '%B30[37]%'
AND ( Any_Appointment_Diagnosis LIKE '%Z421%')

AND (NOT( Any_Appointment_Diagnosis LIKE '%T85[487]%'

OR Any_Appointment_Diagnosis LIKE '%N60[0123489]%'
OR Any_Appointment_Diagnosis LIKE '%N61%'
OR Any_Appointment_Diagnosis LIKE '%N63%'
OR Any_Appointment_Diagnosis LIKE '%N64[01234589]%'
OR Any_Appointment_Diagnosis LIKE '%C84[6789]%'
OR Any_Appointment_Diagnosis LIKE '%Y812%'
)
OR Any_Appointment_Diagnosis IS NULL
)
-- Age Between 19 and 120
AND isnull(OPA.Age_at_Start_of_Episode_SUS,OPA.Der_Age_at_CDS_Activity_Date) between 18 AND 120
THEN '3A_Breast_Prosthesis_Removal'

Exclusions

WHERE 1=1
-- Patient Has Attended Appointment
AND Attendance_Status IN (5,6)
-- Cancer Diagnosis Exclusion Codes
AND (( Any_Appointment_Diagnosis not like '%C[0-9][0-9]%'
AND Any_Appointment_Diagnosis not like '%D0%'
AND Any_Appointment_Diagnosis not like '%D3[789]%'
AND Any_Appointment_Diagnosis not like '%D4[012345678]%')
OR Any_Appointment_Diagnosis IS NULL)

-- Private Appointment Exclusion
AND opa.Administrative_Category<>'02'

References

  1. NHS. Cosmetic surgery — Breast enlargement (implants) 2019
  2. Medicines and Healthcare products Regulatory Agency. Breast Implant Associated Anaplastic Large Cell Lymphoma. 2017.
  3. Association of Breast Surgery, British Association of Plastic, Reconstructive & Aesthetic Surgeons and Breast Cancer Now. Guidance for the Commissioning of Oncoplastic Breast Surgery. Association of Breast Surgery. 2018. Spear S, Baker J. Classification of Capsular Contracture after Prosthetic Breast Reconstruction. Plastic and Reconstructive Surgery. 1995;96(5):1119-1123
  4. BAPRAS. Patient information. What complications can occur?
  5. Handel N, Garcia M, Wixtrom R. Breast Implant Rupture. Plastic and Reconstructive Surgery. 2013;132(5):1128-1137
  6. Headon H, Kasem A, Mokbel K. Capsular Contracture after Breast Augmentation: An Update for Clinical Practice. Archives of Plastic Surgery. 2015;42(5):532
  7. Malahias M, Jordan D, Hughes L, Hindocha S, Juma A. A literature review and summary of capsular contracture: An ongoing challenge to breast surgeons and their patients. International Journal of Surgery Open. 2016;3:1-7
  8. NHS England. Gender Identity Services for Adults (Surgical Interventions). 2019
  9. Association of Breast Surgery, British Association of Plastic, Reconstructive & Aesthetic Surgeons. Oncoplastic Breast Reconstruction Guidelines for Best Practice. Breast Cancer Now. 2018
  10. GOV. UK. Medicines and Healthcare products Regulatory Agency. 2020. Breast implants and Anaplastic Large Cell Lymphoma (ALCL)
  11. Swerdlow S, Campo E, Pileri S, Harris N, Stein H, Siebert R et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016;127(20):2375-2390
  12. BAAPS. Joint statement from ABS, BAAPS and BAPRAS Advice regarding Breast Implant safety. 2019
  13. GOV.UK. Symptoms sometimes referred to as Breast Implant Illness. 2020.
  14. NICE. Perioperative care in adults. [NG180] 2020.



 




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