Implant Registries Research Articles

History of the Australian Breast Device Registry

Following the Dow Corning crisis in the 1990s, several national breast implant registries were formed by plastic surgery societies around the world. The Australian Breast Implant Registry (BIR) was developed in 1997 as a voluntary registry where patients were charged a moiety per implant. At the time of the Poly Implant Prothèse (PIP) crisis in 2010, there were over 30,000 registrations in the BIR. However, when the dataset was interrogated to retrieve PIP implant-related information, only 3.4 per cent of 13,000 PIP implants were recorded in the BIR database.

Improvements in Quality, Safety and Costs Associated with Use of Implant Registries Within a Health System

Clinical quality registries (CQRs) are intended to enhance quality, safety, and cost reduction using real-world data for a self-improving health system. Starting in 2001, Kaiser Permanente established several medical device CQRs as a quality improvement initiative. This report examines the contributions of these CQRs on improvement in health outcomes, changes in clinical practice, and cost-effectiveness over the past 20 years. Eight implant registries were instituted with standardized collection from the electronic health record and other institutional data sources of patient characteristics, medical comorbidities, implant attributes, procedure details, surgical techniques, and outcomes (including complications, revisions, reoperations, hospital readmissions, and other utilization measures). A rigorous quality control system is in place to improve and maintain the quality of data. Data from the Implant Registries form the basis for multiple quality improvement and patient safety initiatives to minimize variation in care, promote clinical best practices, facilitate recalls, perform benchmarking, identify patients at risk, and construct reports about individual surgeons. Following the inception of the Implant Registries, there was an observed (1) reduction in opioid utilization following orthopedic procedures, (2) reduction in use of bone morphogenic protein during lumbar fusion allowing for cost savings, (3) reduction in allograft for anterior cruciate ligament reconstruction and subsequent decrease in organizationwide revision rates, (4) cost savings through expansion of same-day discharge programs for joint arthroplasty, (5) increase in the use of cement fixation in the hemiarthroplasty treatment of hip fracture, and (6) organizationwide discontinuation of an endograft device associated with a higher risk for adverse outcomes following endovascular aortic aneurysm repair. The use of Implant Registries within our health system, along with clinical leadership and organizational commitment to a learning health system, was associated with improved quality and safety outcomes and reduced costs. The exact mechanisms by which such registries affect health outcomes and costs require further study.

Discussion: Comparing 200,000 Breast Implants and 85,000 Patients over Four National Breast Implant Registries.

Discussion: Comparing 200,000 Breast Implants and 85,000 Patients over Four National Breast Implant Registries.

The Mandatory German Breast Implant Registry Law: A Model for Sustainable Implant Registries.

Recurrent scandals involving breast implants have revealed that scientific evidence on the performance of these devices is lacking, and passive monitoring systems are not capable of detecting problems at an early stage. The German health authorities therefore decided to implement a prospective, mandatory registry. The aim of this article was to provide information about the advantages of implementing a mandatory registry, the potential hurdles involved, and to establish structural requirements that future registries can use. Since 2018, the authors have assisted the German Ministry of Health in refining the Implant Law and its implementation. They adapted an internationally consented dataset, promoted international data amplification and conducted monthly trial inputs for over 2 years. By identifying several key issues they were able to assist in developing solutions. The cooperation with the authorities was characterized by appreciation of the authors' expertise and previous international work. Challenges included data privacy issues, federal competence, longitudinal follow-up, and contact data; as well as associated costs and technical solutions for data inclusion and the use of information technology to communicate with stakeholders. Addressing these challenges required considerable interference with personal rights and complementary measures for all stakeholders. Extensive structural precautions were taken to safeguard personal data privacy as far as possible. The authors' experience and lessons learned can guide registries seeking to engage in high levels of evidence data. The authors describe their approach, the obstacles they encountered, and the strategies employed to overcome the setbacks of other registries.

Comparing 200,000 Breast Implants and 85,000 Patients over Four National Breast Implant Registries.

Growing awareness about breast implant-related adverse events has stimulated the demand for large, independent data resources. For this, data from breast implant registries could be combined. However, that has never been achieved yet. Real-world data from four currently active national breast implant registries were used. All permanent breast implants from the Australian, Dutch, Swedish, and American registries were included. A subpopulation present across all registries between 2015 and 2018 was subsequently selected, including only permanent breast implants inserted during primary surgery for breast reconstruction or augmentation in patients without previous breast device surgery. Nationwide coverage, patient and implant characteristics, infection control measures, and revision incidences were analyzed. A total of 207,189 breast implants were registered. Nationwide coverage varied between 3% and 98%. The subpopulation included 111,590 implants (7% reconstruction, 93% augmentation). Across the registries, mean patient age varied between 41 and 49 years ( P < 0.001) for reconstruction and 31 and 36 years ( P < 0.001) for augmentation. Variation was observed in implant preferences across the countries and over the years. Infection control measures were most frequently registered in Australia. Cumulative revision incidence at 2 years ranged from 6% to 16% after reconstruction and from 1% to 4% after augmentation. For the first time, independent, national, registry-based data from four breast implant registries were combined. This is a powerful step forward in optimizing international breast implant monitoring, evidence-based decision-making, and patient safety.

Using a Digital Implant Catalog Improves Data Quality and Reduces Administrative Burden in the Dutch Breast Implant Registry.

Correct registration of implant characteristics is essential to monitor implant safety within implant registries. Currently, in the nationwide Dutch Breast Implant Registry (DBIR), these characteristics are being registered manually by plastic surgeons, resulting in administrative burden and potentially incorrect data entry. This study evaluated the accuracy of manually registered implant data, possible consequences of incorrect data, and the potential of a Digital Implant Catalog (DIC) on increasing data quality and reducing the administrative burden. Manually entered implant characteristics (fill, shape, coating, texture) of newly inserted breast implants in the DBIR, from 2015 to 2019, were compared with the corresponding implant characteristics in the DIC. Reference numbers were employed to match characteristics between the 2 databases. The DIC was based on manufacturers' product catalogs and set as the gold standard. A total of 57,361 DBIR records could be matched with the DIC. Accuracy of implant characteristics varied from 70.6% to 98.0%, depending on the implant characteristic. The largest discrepancy was observed for "texture" and the smallest for "coating." All manually registered implant characteristics resulted in different conclusions about implant performance compared with the DIC (P < 0.01). Implementation of the DIC reduced the administrative burden from 14 to 7 variables (50%). Implementation of a DIC increases data quality in the DBIR and reduces the administrative burden. However, correct registration of reference numbers in the registry by plastic surgeons remains key for adequate matching. Furthermore, all implant manufacturers should be involved, and regular updates of the DIC are required.

CORR Insights®: Collection and Reporting of Patient-reported Outcome Measures in Arthroplasty Registries: Multinational Survey and Recommendations.

CORR Insights®: Collection and Reporting of Patient-reported Outcome Measures in Arthroplasty Registries: Multinational Survey and Recommendations.

Assessment of Extractability and Accuracy of Electronic Health Record Data for Joint Implant Registries

Implant registries provide valuable information on the performance of implants in a real-world setting, yet they have traditionally been expensive to establish and maintain. Electronic health records (EHRs) are widely used and may include the information needed to generate clinically meaningful reports similar to a formal implant registry. To quantify the extractability and accuracy of registry-relevant data from the EHR and to assess the ability of these data to track trends in implant use and the durability of implants (hereafter referred to as implant survivorship), using data stored since 2000 in the EHR of the largest integrated health care system in the United States. Retrospective cohort study of a large EHR of veterans who had 45 351 total hip arthroplasty procedures in Veterans Health Administration hospitals from 2000 to 2017. Data analysis was performed from January 1, 2000, to December 31, 2017. Total hip arthroplasty. Number of total hip arthroplasty procedures extracted from the EHR, trends in implant use, and relative survivorship of implants. A total of 45 351 total hip arthroplasty procedures were identified from 2000 to 2017 with 192 805 implant parts. Data completeness improved over the time. After 2014, 85% of prosthetic heads, 91% of shells, 81% of stems, and 85% of liners used in the Veterans Health Administration health care system were identified by part number. Revision burden and trends in metal vs ceramic prosthetic femoral head use were found to reflect data from the American Joint Replacement Registry. Recalled implants were obvious negative outliers in implant survivorship using Kaplan-Meier curves. Although loss to follow-up remains a challenge that requires additional attention to improve the quantitative nature of calculated implant survivorship, we conclude that data collected during routine clinical care and stored in the EHR of a large health system over 18 years were sufficient to provide clinically meaningful data on trends in implant use and to identify poor implants that were subsequently recalled. This automated approach was low cost and had no reporting burden. This low-cost, low-overhead method to assess implant use and performance within a large health care setting may be useful to internal quality assurance programs and, on a larger scale, to postmarket surveillance of implant performance.

A Systematic Review of the National Breast Implant Registry for Application in Korea: Can We Predict "Unpredictable" Complications?

Background and Objectives: Since silicone breast implants were introduced to the market several decades ago, the safety of breast implants has remained controversial. Recently, several studies have explored breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and breast implant illness (BII). Several countries have developed national breast implant registries to improve the safety and quality of breast implant surgery. We performed a systematic review of the current status of national breast implant registries and propose a pilot form of an appropriate breast implant registry model for Korea. Materials and Methods: The systematic review was conducted in accordance with the “preferred reporting items for systematic reviews and meta-analyses (PRISMA) pro forma”. PubMed and Google Scholar databases were searched to identify all articles containing information on national breast implant registries. We limited the search to articles written in the English language from 2010 to 2020. Articles were reviewed by two independent authors. Results: A total of 63 articles related to national breast implant registries, registry principles and national breast implant registry annual reports were identified. After reviewing the literature, 25 national breast implant registry-related articles were included in the full-text synthesis. Currently, four countries, The Netherlands, Australia, Sweden, and the UK, have breast implant registries with well-formed sources for big data. Overall, similarities in data points were detected for three categories: implant-related complications, operation details, and device information. However, there were differences for each registry in terms of governance, funding, and capture rate. Conclusion: After reviewing other countries’ experiences, tentative datasets for the Korean Breast Implant Registry (K-BIR) were developed. The K-BIR can improve the quality of breast implant surgery in Korea by providing datasets on overall processes and outcome measures with quality indicators and risk adjustment factors. This approach will register characteristics of patients and monitor breast implants, complications, and surgical procedures to improve the outcomes of breast implant surgery in Korea. In addition, it can be used as a track-and-trace system with automated notifications to patients in the event of a product recall or other safety concerns related to a specific type of implant.Background and Objectives: Since silicone breast implants were introduced to the market several decades ago, the safety of breast implants has remained controversial. Recently, several studies have explored breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and breast implant illness (BII). Several countries have developed national breast implant registries to improve the safety and quality of breast implant surgery. We performed a systematic review of the current status of national breast implant registries and propose a pilot form of an appropriate breast implant registry model for Korea. Materials and Methods: The systematic review was conducted in accordance with the “preferred reporting items for systematic reviews and meta-analyses (PRISMA) pro forma”. PubMed and Google Scholar databases were searched to identify all articles containing information on national breast implant registries. We limited the search to articles written in the English language from 2010 to 2020. Articles were reviewed by two independent authors. Results: A total of 63 articles related to national breast implant registries, registry principles and national breast implant registry annual reports were identified. After reviewing the literature, 25 national breast implant registry-related articles were included in the full-text synthesis. Currently, four countries, The Netherlands, Australia, Sweden, and the UK, have breast implant registries with well-formed sources for big data. Overall, similarities in data points were detected for three categories: implant-related complications, operation details, and device information. However, there were differences for each registry in terms of governance, funding, and capture rate. Conclusion: After reviewing other countries’ experiences, tentative datasets for the Korean Breast Implant Registry (K-BIR) were developed. The K-BIR can improve the quality of breast implant surgery in Korea by providing datasets on overall processes and outcome measures with quality indicators and risk adjustment factors. This approach will register characteristics of patients and monitor breast implants, complications, and surgical procedures to improve the outcomes of breast implant surgery in Korea. In addition, it can be used as a track-and-trace system with automated notifications to patients in the event of a product recall or other safety concerns related to a specific type of implant.

The National Dutch Breast Implant Registry: user-reported experiences and importance

Robust (inter-)national breast implant registries are important. For some, registries are an administrative burden, for others they represent a solution for the discussions involving breast implants. The DBIR is one of the first national, opt-out, clinical registries of breast implants, providing information for clinical auditing and product recall. Four years after its introduction, it is time to address users’ comments in order to keep improving quality of registration, and patient safety. This study assesses users’ feedback focusing on importance of registration, logistics and user experience, and areas of improvement. In May 2018, a standardized online study–specific questionnaire was sent out to all members of the Netherlands Society of Plastic Surgery. Descriptive statistics were reported in absolute frequencies and/or percentages. A total of 102 members responded to the questionnaire (response rate, 24.2%). Of all respondents, 97.1% were actively registering in DBIR. Respondents rated the importance of registration in DBIR as 8.1 out of 10 points. Ninety-one respondents suggested improvements for the DBIR. All comments were related to registration convenience and provision of automatically generated data. Respondents believe that registration is highly important and worth the administrative burden. However, we should collectively keep improving accuracy, usability and sustainability of breast implant registries. The primary focus should be on the user interface; on user friendliness, automation, and data reusability. These users’ responses function as a new incentive and provide learning points that are easy to extrapolate to others who want to set up or improve breast implant registries. Level of evidence: Not ratable.

Toward International Harmonization of Breast Implant Registries: International Collaboration of Breast Registry Activities Global Common Data Set.

The Poly Implant Prothèse incident and breast implant-associated anaplastic large cell lymphoma have pointed to the need for uniform registries for breast implants as key features to monitoring the outcomes of breast implant surgeries internationally. The purpose of this study was to identify and harmonize common data elements collected by breast implant registries across the International Collaboration of Breast Registry Activities (ICOBRA) global consortium. The authors convened an international group of surgeons, consumers, nurses, registry experts, and regulators to review the data points. A modified Delphi approach was applied, to rate the importance of each point on a six-point Likert scale. Data points from six national breast implant registries were divided into categories: clinical, implant-related, patient-reported findings; operation details and implanting technique details; patient characteristics; unique device identifiers; unique patient identifiers; and clinical demographics. A total of 52 data points collected by over 33 percent of national registries were identified. After five rounds, 34 data points formed the final set with agreed definitions. The group recognized the critical importance of additional elements that are currently not uniformly collected (e.g., patient-reported outcomes and long-term data) and set out the process for the dynamic global set updates driven by evidence gaps. The authors defined internationally agreed on common data elements and definitions used in breast implant registries. This collaboration will allow data sets to be combined, enabling an effective global early warning system of implant-related problems and further work on data sets.

Lessons Learned From Breast Implant Registries: A Systematic Review.

Over several decades, numerous national and international registries on breast implants went online, aiming to collect prospective data to provide increased safety for patients and surgeons. We performed a review of all published data on breast implant registries to assess availability and quality of data and determine its usefulness and impact. PubMed, Ovid, and Web of Science were searched to identify all articles containing breast implant registries in English language. The review was registered at PROSPERO (CRD42016041255) and performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. There was no limitation by publication date. Eight hundred ninety-five articles were identified; after removal of duplicates, 536 abstracts were screened on breast implant registries in plastic and reconstructive surgery. Unrelated articles, non-English articles, and not breast implant-related studies were excluded. Twenty breast implant registry-related articles met the inclusion criteria; 7 articles contained actual data on breast implants. Compared with international trends, only a minimal percentage of performed surgical breast augmentations is documented in registries, and the overall data quality and availability were low. Only a fraction of performed breast augmentations is documented properly in a registry. Currently, there are no published data based on a clinical quality registry. Sustained funding and reliable administrative governmental structures remain crucial to establish an adequate clinical quality registry for breast implants as currently launched in Australia to analyze outcomes and risk factors for an increased patient safety.

How to improve patient safety and quality of care in breast implant surgery? First outcomes from the Dutch Breast Implant Registry (2015–2017)

Although the use of breast implants is generally considered to be safe, breast implants are associated with short- and long-term complications. To evaluate and improve the quality of breast implant surgery, and increase our knowledge of implant performance, the national Dutch Breast Implant Registry (DBIR) was established in 2015. DBIR is one of the first up-and-running breast implant registries worldwide and follows an opt-out structure. This article provides an overview of the first outcomes and experiences of the DBIR. The national coverage of DBIR was studied using data from the Dutch Health and Youth Care Inspectorate. The incidence rate of breast implants was calculated for 2016 and 2017, and patient, device, and surgery characteristics were compared between cosmetic breast augmentations or reconstructive indications. Four infection control, measures were selected to demonstrate the variation in the Dutch clinical practice. In 2016, 95% of the hospitals and 78% of the private clinics participated in DBIR. Between 2015 and 2017, a total of 15,049 patients and 30,541 breast implants were included. A minimum breast implant incidence rate of 1 per 1,691 women could be determined for 2017. The majority of devices were inserted for a cosmetic indication (85.2%). In general, patient, device, and surgery characteristics differed per indication group. Substantial variation was seen in the use of infection control measures (range 0-100%). Preliminary results obtained from DBIR show high national participation rates and support further developments toward the improvement of breast implant surgery and patient safety.

Cardiac implant registries 2006–2016: a systematic review and summary of global experiences

ObjectivesThe importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to...

The experience of the RIPO, a shoulder prosthesis registry with 6-year follow-up.

Implant registries have proved valuable in assessing the outcomes of arthroplasty procedures. Moreover, by identifying lesser quality implants they have indirectly improved the quality of care. The registry of prosthetic shoulder implants was established in 2008. It records information on all types of primary and revision arthroplasty procedures involving the glenohumeral joint, including reverse and total arthroplasty, hemiarthroplasty, resurfacing, removal, and any other surgical procedures that are required to manage these patients. The collected data include patient demographics, weight, height, operated side, cuff status, and diagnosis/reason for revision surgery, information on previous surgical procedures involving either shoulder, comorbidities, antibiotic and thromboembolic prophylaxis, blood transfusions, surgical approach, cuff repair procedures performed during arthroplasty, bone grafts, drains, and perioperative complications, and data about the prosthetic components implanted, including the fixation method. Procedures were performed on 3754 shoulders. They included 2226 RSA, 320 TSA, 730 HA, 233 resurfacing procedures, 245 revisions, and 77 "other" procedures. The survival curves of the implants are greater than 90%, and no differences were found among prosthesis from different manufacturers. The diagnosis that prompted to arthroplasty was: osteoarthritis in 60.9% of cases and fractures, bone necrosis, sequelae of fracture and rotator cuff tear arthropathy for the rest of implants. This study describes the epidemiological data and mid-term implant outcomes of the shoulder arthroplasty procedures performed in our region, from 2008 to 2014, and compares them with published data from national registries of similar size. III.

Commentary on “The new opt-out Dutch national breast implant registry – Lessons learnt from the road to implementation”

The Dutch can be considered fortunate in, unlike many other countries, an estimated 95% of implants are used by a single craft group and funding for a breast implant registry is forthcoming. 1 Rakhorst H.A. Mureau M.A.M. Cooter R.D. et al. The new opt-out Dutch national breast implant registry – Lessons learnt from the road to implementation. J Plast Reconstr Aesthet Surg. 2017; 70: 1354-1360 Abstract Full Text Full Text PDF Scopus (31) Google Scholar The authors point out that the variance between the quality and uptake around the world of different registry projects has detracted from the ability to extract useful information from these data bases in the past, and believe that an opt out system will improve the situation. ICOBRA was established to increase the homogeneity of the data set, but without universality of uptake as in the Dutch system, assemblage of these various sources is questionable. The new opt-out Dutch National Breast Implant Registry – Lessons learnt from the road to implementationJournal of Plastic, Reconstructive & Aesthetic SurgeryVol. 70Issue 10PreviewAn estimated 1–3% of all women in the Netherlands carry breast implants. Since the introduction five decades ago, problems with a variety of breast implants have emerged with direct consequences for the patients' health. Plastic surgeons worldwide reacted through campaigning for auditing on long-term implant quality, surgeon performance, and institutional outcomes in implant registries. Especially, the PIP implant scandal of 2010 demonstrated the paucity of epidemiological data and uncovered a weakness in our ability to even ‘track and trace’ patients. Full-Text PDF

The new opt-out Dutch National Breast Implant Registry – Lessons learnt from the road to implementation

An estimated 1-3% of all women in the Netherlands carry breast implants. Since the introduction five decades ago, problems with a variety of breast implants have emerged with direct consequences for the patients' health. Plastic surgeons worldwide reacted through campaigning for auditing on long-term implant quality, surgeon performance, and institutional outcomes in implant registries. Especially, the PIP implant scandal of 2010 demonstrated the paucity of epidemiological data and uncovered a weakness in our ability to even 'track and trace' patients. In addition, a recent report of the Dutch Institute of National Health showed a lack of compliance of 100% of breast implant producers to CE requirements. These arguments stress the need for an independent implant registry. Insufficient capture rates or dependence from the implant producers made the variety of national and international patient registries unreliable. The Dutch Breast Implant Registry (DBIR) is unique because it is an opt-out registry without the need for informed consent and thus a high capture rate. Furthermore, an estimated 95% of breast implants are implanted by board-certified plastic surgeons. Funding was received from a non-governmental organisation to increase the quality of health care in the Netherlands, and maintenance is gathered by 25 euros per implant inserted. This article describes the way the Dutch have set up their system, with special attention to the well-known hurdles of starting a patient registry. Examples include: funding, medical ethical issues, opt out system, benchmarking, quality assurance as well as governance and collaboration. The Dutch consider their experience and data shareware for others to be used globally to the benefit of patient safety and quality improvement.

MD4 - Quality Criteria for the Development of Implant Registries

MD4 - Quality Criteria for the Development of Implant Registries

The Kaiser Permanente Implant Registries: Effect on Patient Safety, Quality Improvement, Cost Effectiveness, and Research Opportunities

Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.

The variability of surgical practice during total knee arthroplasty: results of a national survey amongst Belgian knee surgeons

Implant registries have been effective in detecting poorly performing implants and surgical strategies. They learn us however little about many variables that may be equally important to the final result. Today, no standards of care exist for performing total knee arthroplasties (TKA), and little is known about the variability that exists amongst surgeons performing this procedure. A questionnaire with 39 aspects regarding standard surgical routine during TKA was sent to all 112 members of the Belgian Knee Society. Surgeons were stratified according to surgical experience and surgical volume. An important number of routines were performed as standard by the majority (>70%) of surgeons. Surgeons however significantly differed in the following aspects of the procedure: radiographic evaluation, use of minimally invasive surgery (MIS), preferred landmark for femoral component rotation, method of closure and activities allowed postoperatively. Both surgical experience and surgical volume had a significant effect, but their influence on strategies was different. Less-experienced surgeons used the posterior condylar line as their reference for femoral component rotation significantly more frequent than more-experienced surgeons and were more aggressive towards postoperative sports activities compared to more-experienced surgeons. High-volume surgeons used significantly more frequent MIS and low-volume surgeons preferred a more extensive postoperative radiographic evaluation. Data of this study show that an important number of routines are performed similarly by the majority of surgeons, and that minor but significant differences exist between high-volume versus low-volume surgeons, and between experienced versus less-experienced surgeons. Case series, Level IV.