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The TGA is requesting timely reporting of any adverse events associated with the use of acellular dermal matrix (ADM) products used in breast reconstruction surgery to help us assess if they are associated with higher complication rates in Australia.
The US Food and Drug Administration (FDA) issued a safety communication in March 2021 regarding ADM products used in implant-based breast reconstruction. The FDA's analysis suggested that two ADMs, FlexHD and Allomax, may have a higher risk profile than others. In particular, there were higher rates of major complications, explanation, additional operations and infections two years following surgery.
Of the two products identified by the FDA, FlexHD is the only product currently included in the Australian Register of Therapeutic Goods (ARTG). There are three types of Flex HD included on the ARTG (AUST I 211608, start date 1/07/2013), FlexHD (Structural), FlexHD Pliable, FlexHD Pliable Shaped Perforated.
FlexHD is derived from human skin. Its intended use is for the replacement of damaged or inadequate integumental tissue in the patient, or for reinforcement or supplemental support of soft tissue defects. The Sponsor (Johnson & Johnson Medical Pty Ltd t /a DePuy Synthes) states that only FlexHD Pliable and FlexHD Pliable Shaped Perforated are intended for use in breast reconstruction surgery.
The FDA review was based on data from the Mastectomy Reconstruction Outcomes Consortium (MROC) study, which is a prospective, cohort study collecting data from 11 centres, including nine academic hospitals, in the United States and Canada with high volumes of breast reconstruction surgery [1], [2]. The FDA review focussed on data collected from 2012 to 2015 and it is noted that this included predominantly use of the FlexHD (Structural) product, as Flex-HD Pliable products were not available until 2013.
The FDA statement does not recommend preventative reoperation or removal of implanted ADM. The FDA statement further highlights that it is not aware of any association between ADM usage and the development of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) at this time.
The Australian Sponsor has noted that there are a number of more recent peer reviewed, published clinical safety studies utilizing FlexHD Pliable products which do not suggest a higher risk profile, nor higher rates of major complication, explantation or infection when used in breast reconstruction surgery [3], [4], [5].
The TGA has received a small number of adverse event reports for FlexHD used in breast reconstruction that are consistent with the known safety profile. These events include erythema, fever, infection, product extrusion and product breakage.
Instructions for reporting adverse events can be found here.
As part of the TGA's review we may seek advice from TGA's advisory committees, expert working groups or other relevant independent experts.
Information for consumers
FlexHD (Structural)
Consumers should note that FlexHD (Structural) has not been available in Australia since 2019 and is not intended for use in breast reconstruction.
If you have undergone an implant-based breast reconstruction that used FlexHD or any other ADM, and you wish to discuss this issue, contact your general practitioner or surgeon for individual clinical assessment and advice.
Allomax
Consumers should also note that Allomax is not approved for use in Australia at this time and so is not subject to this safety advisory.
However, women who have had breast implant procedures performed outside of Australia may wish to check with their overseas surgeon as to which ADM, if any, was used in their procedure and to seek further information.
General
Consumers should always consult their general practitioner or surgeon in the event of any adverse effects from any procedure, including breast reconstruction procedures.
Information for all health professionals
Health professionals who are treating a patient who has undergone an implant- based breast reconstruction that used FlexHD or any other ADM should be alert to this potential issue.
TGA recommends that health professionals intending to use Flex HD Pliable or FlexHD Pliable Shaped Perforated for breast reconstruction should discuss the risks and benefits of the use of the product with prospective patients and document informed consent prior to any procedure.
Reporting problems
Consumers and health professionals are encouraged to report problems with acellular dermal matrix (ADM) products. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
What to report? Please report adverse events, as well as near misses
The TGA encourages the reporting of any suspected adverse event or potential adverse event relating to a medical device. Adverse events can involve actual harm to a patient or caregiver, or a near miss that may have resulted in harm.
Some issues relating to medical devices that may lead to adverse events and prompt you to report include:
- mechanical or material failure
- design issues
- labelling, packaging or manufacturing deficiencies
- software deficiencies
- device interactions
- user/systemic errors.
Suspected adverse events or near misses can be reported directly to the TGA:
- online at Report a problem
- by emailing iris@tga.gov.au
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.
Disclaimer
The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device safety, including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or reliance on the information provided in this document.
© Commonwealth of Australia 2022
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au.
For the latest information from the TGA, subscribe to the TGA Safety Information email list.
For correspondence or further information about Medical Devices Safety Update, contact the TGA's Medical Devices Branch at iris@tga.gov.au or 1800 809 361.
Footnotes
| [1] | Sorkin M, et al. Acellular Dermal Matrix in Immediate Expander/Implant Breast Reconstruction: A Multicenter Assessment of Risks and Benefits. Plast Reconstr Surg. 2017 Dec; 140(6): 1091-1100. |
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| [2] | Ganesh Kumar N, et al. Development of an evidence-based approach to the use of acellular dermal matrix in immediate expander-implant-based breast reconstruction. J Plast Reconstr Aesthet Surg. 2021 Jane; 74(1). |
| [3] | Sobti N, Liao EC. Surgeon-Controlled Study and Meta-Analysis Comparing FlexHD and AlloDerm in Immediate Breast Reconstruction Outcomes. Plast Reconstr Surg. 2016 Nov;138(5):959-967. |
| [4] | Chang, E. I. & Liu, J. Prospective unbiased experience with three acellular dermal matrices in breast reconstruction. Journal of Surgical Oncology 116, 365-370, doi:10.1002/jso.24656 (2017). |
| [5] | Vu MM, De Oliveira GS Jr, Mayer KE, Blough JT, Kim JY. A Prospective Study Assessing Complication Rates and Patient-Reported Outcomes in Breast Reconstructions Using a Novel, Deep Dermal Human Acellular Dermal Matrix. Plast Reconstr Surg Glob Open. 2016 Jan 7;3(12):e585. |