Transforming Australia’s Breast Implant Registry

Breast implants have long been a subject of media hype and controversy. Despite the debate surrounding the use of silicone prostheses in the 1990s, demand continues virtually unabated. Although Australia has a registry of breast implants, it has recently become clear that it contains insufficient data to provide comprehensive implant statistics. Growing concerns regarding lymphoma risk and the recall of one brand of implant have highlighted the need for more complete data on implantable breast devices.

Plastic surgeons regularly use silicone breast prostheses for augmentation mammaplasty, comprising about 80% of procedures, and breast reconstruction after breast cancer surgery, comprising about 20%.1 In the United States, breast augmentation is the most common aesthetic surgical operation, with 296 203 breast augmentations and 93 083 breast reconstructions performed in 2010.2 About 1% of women in the US have breast implants.3

Silicone breast implants have been erroneously implicated in causing a variety of disease states.4,5 Such assertions resulted in several individual legal challenges, and a lack of postmarketing safety data led the US Food and Drug Administration (FDA) to place a voluntary moratorium on the use of silicone gel-filled implants in January 1992.6 The moratorium was lifted in November 2006, when the FDA felt that there were then sufficient data to prove the safety and efficacy of silicone implants. Two companies’ products were approved for marketing, with the caveat that large postapproval studies be performed.7,8 These and other large trials have failed to find a strong association between silicone implants and connective tissue disorders, carcinogenesis or autoimmune disease.9-12

The paucity of available evidence for evaluating the risk of implants and for use in the subsequent legal battles has highlighted the lack of scientific rigour that pervades current legal and public opinion.13 A 2009 review of health technology assessment in Australia recommended regulatory reforms that included tighter postmarketing surveillance and more flexibility in evaluating and comparing new technologies.14 In particular, it focused on reviewing devices of high risk or cost where there is new evidence regarding safety, or there is public interest or controversy. Silicone breast implants fall into both these categories.

In Australia, the Therapeutic Goods Administration (TGA) is legislated to register and regulate therapeutic goods and devices according to the Therapeutic Goods Act 1989 (Cwlth). The TGA is funded via fees charged to companies that apply to have goods registered and licensed. In terms of postmarketing surveillance, the TGA relies on a self-reporting scheme, known as the medical device incident reporting and investigation scheme (IRIS), to identify problems with medical devices. As the TGA regulates access to the market but does not record implantation data, the audit cycle for establishing the safety and quality of new and existing medical devices is not complete.

Recognising the need for an audit mechanism in Australia, the voluntary, patient-funded Breast Implant Registry (BIR) was established by a group of plastic surgeons in 1998 to maintain a national database of breast implants.15 It has ongoing status as a federal Department of Health and Ageing quality assurance activity under the Qualified Privilege Scheme, in accordance with the Health Insurance Act 1973 (Cwlth). This allows the freedom to gather health information without threat of subpoena, thereby protecting both patients and surgeons. The BIR, which is available to all doctors who perform implant procedures, is administered by the Australian Society of Plastic Surgeons. To 2009, 31 939 implants had been logged in the BIR (End of first triennium report. Breast Implant Registry baseline data: January 1998 to February 2009. Report sent to Department of Health and Ageing, 11 August 2009).

The BIR is limited by being an incomplete dataset. Its “opt-in” basis is further compromised by an inability to validate data against the total number of implants sold, because implant suppliers have traditionally considered their sales data to be commercially sensitive. The current system relies on the patient paying $25 per implant to the implant distributor, who then forwards it to the BIR. Concurrently, the surgeon fills out a form of several pages in length, which is independently sent to the BIR. As well as pertinent information regarding the brand and model of implant and the patient’s and surgeon’s details, a large amount of ancillary data, such as perioperative procedures and patient satisfaction, is also requested. This process is unnecessarily disjointed and cumbersome. There is no incentive for the patient, surgeon or implant distributor to participate in the scheme, and there is no audit to confirm that all aspects of the process are completed.

Recent international events have uncovered the specious nature of the Australian BIR and highlighted a pressing need to investigate ways to make breast implant data capture more scientifically valid.

In 2010, the French regulatory authority, Agence française de sécurité sanitaire des produits de santé, found that French company Poly Implant Prothèse (PIP) had breached manufacturing standards by using unlicensed silicone polymers and other compounds in production, and it issued a recall in March of that year.16 This raised international concern about a possible increase in implant rupture rate. Regulatory authorities in countries including France, Germany and the Czech Republic have recommended the removal of PIP implants. In Australia, an alert was issued on the TGA website on 6 April 2010 stating that all non-implanted PIP products were being recalled and that the TGA was investigating the incidence of ruptures.17 An update on 4 January 2012 indicated that the TGA had reviewed all self-reported failures of the product in Australia but had insufficient information to accurately determine true rupture rates.18 Although in this instance the warning was raised overseas, the IRIS is obviously limited by relying on self-reporting of complications and malfunctions by clinicians, patients and suppliers.

Between 1998 and March 2010, more than 6000 Australian women received over 12 000 implants manufactured by PIP.19 Throughout the same period, the BIR recorded a total of 423 PIP implants in 215 patients. Although these data are for only one of several brands of breast implants used by Australian surgeons, if considered representative, this extrapolates to a BIR capture rate of 3.4%, which indicates it is a manifestly inadequate dataset. This problem is not unique to Australia. The funding for an analogous voluntary breast implant registry in the United Kingdom was withdrawn in 2006 after an investigation into low data quality and capture rate.20

Another concern to patients and surgeons is a possible association between breast implants and T-cell lymphoma. Small case reports and one retrospective study described anaplastic large T-cell lymphoma surrounding silicone and saline implants with textured surfaces.21,22 Five cases are known to have occurred in Australian women.23 However, a review of five long-term studies has failed to confirm a causal relationship between silicone and T-cell lymphoma.24 Although the absolute risk appears to be small, it must be acknowledged, and possible causes require further investigation. Physicians must be alert to the possibility of lymphoma in patients with textured implants and establish management protocols for breast swelling and periprosthetic seroma.25-27

These issues indicate a clear need for improved collection of breast implant data in Australia. A prospective, validated and complete breast device registry would potentially capture the numbers required to detect increased rupture rates or associated disease risk. Further, renaming the existing BIR as the Breast Device Registry would embrace patients undergoing breast reconstruction with tissue expanders, as well as those receiving implants.

There are several analogous registries in Australia, such as the National Breast Cancer Audit, the Australia and New Zealand Dialysis and Transplant Registry, the Australian Cardiac Procedures Registry and the Australian Orthopaedic Association’s National Joint Replacement Registry. Monash University administers a Registry Special Interest Group to build relationships and collaborations between clinical registry parties,28 and the BIR custodians have participated in this group. To aid in developing and running successful clinical quality registries, the Australian Commission on Safety and Quality in Health Care (ACSQHC) published Operating principles and technical standards for Australian clinical quality registries in 2008.29 These guidelines recommended that a registry should have a simple minimum dataset, mandatory participation (ie, an opt-out model with provision for non-participation), and outcome measurement, and should be validated and have clear governance, privacy and security. The National Joint Replacement Registry, which began in 1999 and records almost all Australian joint replacement procedures, is an example of a successful registry model. It employs an opt-out system and very few patients have chosen not to participate, which has enabled it to identify the early failure of faulty implants with poor outcomes.30

In contrast with the current voluntary BIR, the proposed Breast Device Registry would comply with the ACSQHC standards and recommendations. This would include implementing an opt-out system, to guarantee a higher data capture rate, and high levels of compliance could be ensured by validation against hospital discharge data. Revising and simplifying the form should also allow more meaningful secondary data analysis.

There are other potential benefits of a more complete registry. With an increase in primary breast implant procedures, the rate of revision surgery will also increase. In one study, 28% of patients required further implant-related surgery for problems such as capsular contracture, rupture or haematoma.31 In such cases, a different surgeon may perform the second surgery, or if a long period of time has passed, there may be difficulty ascertaining the type and size of implant if the patient has not kept a personal record or enrolled in a registry. Relevant medical records may be destroyed before the end of the expected prosthesis life span.

In case of a recall or a risk associated with an implant, patients and surgeons could easily be identified and contacted through the Breast Device Registry. This body of information could safeguard patients, assist surgeons in making decisions, and allow manufacturers to provide information to consumers regarding their products. Surgeons could access their own data and monitor surgical outcomes, consistent with the continuing professional development guidelines of the Royal Australasian College of Surgeons.

Clinical quality registries are a necessary public health initiative. We propose that a new Australian Breast Device Registry move towards compliance with the ACSQHC standards, in particular by using an opt-out system. With a new registry, we can benchmark current complication and re-operation rates as a whole, or by implant or procedure type. Concerns about implant composition, defects or disease associations can be confirmed or refuted with access to a large dataset. A revised Australian Breast Device Registry can help resolve these difficult questions.