Breast implant recall tip sheet for practitioners

Breast implant recall tip sheet for practitioners

Summary:
Tips to help practitioners respond to patient questions about the TGA’s suspension of some devices in October 2019, due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

GPsCosmetic PracticesPlastic surgeryCosmeticManaging patient incidentsFactsheetsPatient care
14 / 11 / 2019

Patients who have had an implant

Proactively contact affected patients

Although not a requirement such action allows you to address patient concerns early and will be seen as a positive response, in particular if you have used the grade 3 and 4 implants recalled by Allergan or suspended by the TGA. This also provides the opportunity to prompt women to check their breasts regularly and contact you if they have concerns. Ask your college or society about a template you can use for contacting patients.

Discuss the implications

Offer your patients who have textured breast implants the opportunity to talk with you.

  • Communicate in an empathetic and sensitive manner as patients may be distressed.
  • Assist your patients who are unsure, to clarify whether they have textured or smooth implants and which type (records may be obtained from the hospital where the surgery was performed). The proposed suspension does not affect smooth breast implants.
  • Explain the risk of BIA-ALCL and provide the patient with the next steps and options about ongoing monitoring, investigations and removal of implants (should it be clinically indicated or the patient requests for implant removal).
  • Provide the TGA and ASPS information about BIA-ALCL to the patient.
  • Give consideration to the fact breast implants are not lifetime devices and may need to be replaced after approximately 10 to 15 years.

Symptomatic patients

BreastSurgANZ recommends review plus ultrasound with or without aspiration (biopsy). Be clear about the costs of investigations and/or surgery. On a case by case basis you may consider bulk billing (provided the item number descriptor is met). Advise the patient to consult with their GP to obtain a valid referral for specialist consultation. This TGA factsheet provides more details regarding related Medicare benefits. Obtain financial consent, and consent for procedure, in accordance with the AMA’s recommended process.

Removal of implants

Referral to the public system is the only apparent option for women who cannot afford to remove their implants privately and meet the MBS item number requirements. If the patient elects to remove their implants through private healthcare, obtain consent for the procedure alongside financial consent.

Asymptomatic patients

There is no current evidence to support regular review or ultrasound. Discuss a plan with your patients that addresses their concerns and situation. Patients who notice any sudden changes around their implant, such as new swelling or a lump, should be considered for ultrasound with or without aspiration (biopsy) for BIA-ALCL.

Patients considering breast implants and/or tissue expanders

  • Provide information to your patients including patient information leaflets that have warnings and risks associated with the product. BreastSurgANZ has example patient information available to its members.
  • Read the updated manufacturer’s instructions to maintain currency about the incidence of BIA-ALCL with respect to the implants or tissue expanders being used, so you have current knowledge about the risk of BIA-ALCL for that product.
  • Throughout the consent discussion explain the risks associated with treatment (including BIA-ALCL) and partner with the patient to enable an informed decision. You may consider a second consultation with the patient to assess their understanding about the procedure and address further questions.
  • Be clear about the costs of surgery and the potential costs for further surgery and investigations should complications arise post procedure.
  • Report problems with breast implants to the Therapeutic Goods Administration (TGA) and the Australian Breast Device Registry. More information about reporting is available on the TGA Incident Reporting and Investigation Scheme (IRIS).


Additionally, review and update your advertising and marketing – assess websites and materials to ensure messages are consistent and align with the current evidence regarding BIA-ALCL.

We encourage surgeons to enter implant cases into the Australian Breast Device Registry to collect data to improve patient outcomes. Information related to the Australian Breast Device Registry supports on-going reporting and monitoring.

Resources links

TGA Breast Implant Hub

TGA information for patients: Recall of Allergan textured breast implants: what you should know if you have implants

TGA BIA-ALCL: information for health professionals

Australian Society of Plastic Surgeons – BIA-ALCL patient safety

The Australian College of Cosmetic Surgeons – Breast implant ALCL public information

Breast Cancer Network Australia

TGA alerts – Breast implants and anaplastic large cell lymphoma

This publication is not comprehensive and does not constitute legal or medical advice.You should seek legal or other professional advice before relying on any content, and practice proper clinical decision making with regard to the individual circumstances. Persons implementing any recommendations contained in this publication must exercise their own independent skill or judgment or seek appropriate professional advice relevant to their own particular practice. Compliance with any recommendations will not in any way guarantee discharge of the duty of care owed to patients and others coming into contact with the health professional or practice. Avant is not responsible to you or anyone else for any loss suffered in connection with the use of this information. Information is only current at the date initially published. [November 2019].

For more information or immediate medico-legal advice, call us on 1800 128 268, 24/7 in emergencies.

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