Safety Of Breast Implants Research Articles

Data quality assessment of the Dutch Breast Implant Registry by automated data verification using medical billing data

The Dutch Breast Implant Registry (DBIR) provides real-time population-based data to monitor and improve the quality and safety of breast implants and to trace patients in the event of an (inter)national recall. To serve these main goals, the capture rate and percentage of implants that are actually registered should be known and data should be complete. This study aimed to describe an automated verification process for capture rates and data completeness using medical billing data as the external source. DBIR-data on reconstructive permanent breast implants and tissue expanders (TEs) from 2019 were compared to medical billing data. At the hospital level, the capture rate of DBIR and accuracy of the selected data points were assessed. In total, 2389 implants (1420 patients) were included from 12 participating hospitals (11% of all healthcare institutions registering in DBIR). DBIR had capture rates of 99% to 114% for inserted permanent implants and TEs and 49% for explanted permanent implants and TEs. Among the 9015 data points analyzed in DBIR, 8861 (98%) matched the medical billing data. Mastopexy had the highest matching percentage (100%) and capsulectomy the lowest (86%). This study showed varying capture rates in DBIR depending on the intervention group, indicating that registration of DBIR-data and medical billing codes could be further optimized. Data accuracy was high as only 2% of data points did not correspond to medical billing data. For future data verification, other external data sources could be explored, including sources that enable verification of cosmetic implants.

Breast implant surface topography triggers a chronic-like inflammatory response.

Breast implants are extensively employed for both reconstructive and esthetic purposes. However, the safety of breast implants with textured surfaces has been questioned, owing to a potential correlation with anaplastic large-cell lymphoma and the recurrence of breast cancer. This study investigates the immune response elicited by different prosthetic surfaces, focusing on the comparison between macrotextured and microtextured breast implants. Through the analysis of intraoperatively harvested periprosthetic fluids and cell culture experiments on surface replicas, we demonstrate that macrotextured surfaces elicit a more pronounced chronic-like activation of leucocytes and an increased release of inflammatory cytokines, in contrast to microtextured surfaces. In addition, in vitro fluorescent imaging of leucocytes revealed an accumulation of lymphocytes within the cavities of the macrotextured surfaces, indicating that the physical entrapment of these cells may contribute to their activation. These findings suggest that the topography of implant surfaces plays a significant role in promoting a chronic-like inflammatory environment, which could be a contributing factor in the development of lymphomas associated with a wide range of implantable devices.

Breast Implant Illness: Identifying Patients Concerns from Public Comments on Regulation.gov

INTRODUCTION: Breast Implant Illness is an evolving syndrome that has been gaining traction from the public and the medical community. Patients are experiencing negative emotions towards BII and are dissatisfied with the quality of patient education, as expressed in the public comments submitted in response to the 24OCT2019 FDA draft guidance on breast implant labeling recommendations. To better gauge the patient experience, this study aims to further examine these comments for frequently encountered concerns and themes. METHODS: The comments under the 24OCT2019 Regulations.gov docket were extracted. A team of 14 researchers examined them to detect recurring themes. The comments were then equally and randomly allocated to two independent reviewers to code for the presence of the identified themes, and to a third reviewer for conflict reconciliation. Microsoft Excel was used to quantify theme frequencies. RESULTS: The docket contained 1321 comments, of which 4 were not in English, 10 were duplicates and 449 represented repetitions of a template expressing dissatisfaction with the guidelines. Amongst the remaining 758 comments, we identified the following recurrent concerns and themes: 1) insufficiency of FDA guidelines (present in 37% of the 758 comments), 2) feelings of betrayal by doctors, implant manufacturers and/or insurance companies (29.7%), 3) requesting a complete list of ingredients and metals (18.6%), 4) requesting a patient checklist (15%), 5) surgeons, other physicians, or nurses not being able to explain the patient’s symptoms (13.5%), 6) requesting all breast implants to be banned (10.4%), 7) doctors not acknowledging patients’ BII concerns (8.6%), 8) concern about gel bleed/migration (6.2%), 9) explant not covered by insurance (5.7%), 10) patients recognizing they have BII only after coming across a social media group discussing it, or a friend who has it or read about it (4.2%), 11) requesting advocacy for recognition of BII by insurance companies (3.1%), 12) requesting only silicone breast implants to be banned (2.9%), 13) mention/discussion of the previous silicone implant ban (2.1%). CONCLUSION: Patients are expressing several concerns about the safety of breast implants, the FDA guidelines, breast implant illness, and patient education. Notably, the trust towards the medical community is being questioned as patients feel betrayed and dismissed. Breast implants represent one of the mainstay treatments for post-mastectomy breast reconstruction, and their condemnation may compromise the quality of patient outcomes. Therefore, further research is needed to characterize breast implant illness and improve patient advocacy. Interestingly, the FDA updated their labeling recommendation for improved patient communication to include a patient decision checklist which is also reflected by our findings (15% of comments). Our results can serve as a springboard to proactively address patients concerns for optimized patient-physician relationship and restore the trust that qualified plastic surgeons will always have the patients best-interest in mind.

Single Center and Surgeon's Long-Term (15-19 Years) Patient Satisfaction and Revision Rate of Round Textured Eurosilicone Breast Implants.

Breast augmentation is one of the most commonly performed aesthetic plastic surgical procedures, with over 250,000 procedures in the United States in 2020 alone. However, the safety of breast implants should be closely researched and monitored, especially in the long term. This study was undertaken to evaluate the long-term results of round micro-textured Eurosilicone (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants from a single-center, single-surgeon experience regarding both patient-reported outcome measures and revisions. A retrospective cohort study was undertaken of 84 patients who underwent primary breast augmentation with round micro-textured Eurosilicone Cristalline Paragel breast implants, either submuscular (dual-plane) or subglandular placed, between 2001 and 2004. All patients were contacted for informed consent, and after approval, the validated BREAST-Q questionnaire was sent and utilized to analyze patient satisfaction. In addition, objective data regarding revisions, including capsular contracture, rupture rate, pain, and/or aesthetic causes needing revision surgery, were analyzed. High BREAST-Q scores (67%-100% for 0-100 scale variables and 66.0%-77.3% of the patients scored "very satisfied" on categorical variables) were found without clinically significant differences between patients with dual-plane-placed implants and subglandular-placed implants. The overall revision rate was 29.8%, also with no significant differences between groups (P = 0.317). This study showed high patient satisfaction and relatively low revision rates after 15 to 19 years of follow-up of round micro-textured Eurosilicone Cristalline Paragel breast implants. No clinically relevant significant differences were found between dual-plane and subglandular placement of the implants.

Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: Report of the scientific committee on health, emerging and environmental risks (SCHEER)

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed.Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIA-ALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIA-ALCL for patients with a breast implant.

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 Safety of Silicone Gel-Filled Breast Implants

Few implantable medical devices have been studied for their safety more extensively than silicone gel-filled breast implants. We summarize the epidemiologic evidence on the safety of breast implants, most of which is drawn from large cohort studies with long-term follow-up. The topics addressed in this report include cancer, breast cancer detection, connective tissue disease, suicide, offspring effects, neurologic disease, implant rupture, and local perioperative complications and additional surgery. We conclude that the weight of the epidemiologic evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurologic disease. Women with breast implants do not present with more advanced stages of breast cancer or suffer impaired survival after breast cancer diagnosis. The only study to examine an actual incidence rate of breast implant rupture reported rupture-free survival of 98% at 5 years and 83%-85% at 10 years for newer "third-generation" implants. Future studies are needed to determine whether the consistently observed excess of suicide among women with implants reflects underlying psychiatric illness prior to breast augmentation surgery or other factors.

On the safety of breast implants.

A great deal of recent safety research combined with over 30 years of clinical experience has proven the value and relative safety of these devices. Aside from the side effect of capsular contracture, the complication rate of this surgery approaches that of any clean elective procedure. There is no convincing evidence to date of any systemic disorder that can be attributed to the silicone. Because these are man-made devices they do have a failure rate and in some women can require a significant amount of maintenance. As with all natural body parts these artificial substitutes may be subject to injury or disease and when viewed from that perspective do have very favorable risk benefit characteristics.

To the Editor: New Findings on the Safety of Breast Implants

To the Editor: New Findings on the Safety of Breast Implants

National women's health network and the US FDA: Two decades of activism

The National Women's Health Network (NWHN) in the United States works for more power for women at all levels of health care decision-making. This paper describes some of the campaigns carried outby the Network since the 1970s to influence US Food and Drug Administration (FDA) guidelines and policy. These include: requirements for patient package inserts for oral contraceptives, oestrogen during menopause, and drugs for pregnant women. The Network has also consistently taken up the safety and efficacy of drugs and devices used by women. It has opposed approval of Depo Provera, supported approval of the Prentif cervical cap and the female condom, opposed a large trial of tamoxifen for prevention of breast cancer in healthy women because of its risks, and supported studies on the safety ofbreast implants.

The safety and efficacy of breast implants for augmentation mammaplasty.

This review of the efficacy and safety of breast implants was intended to focus on our current body of knowledge about these devices. There are informational gaps, but not all of these can be laid at the door of imperfect studies or failed scientific methods. Certain properties of the implants are still unmeasurable, immunologic investigation is still evolving, the cause of wound contraction is inexplicable here or in the burnscar contracture, and the indications for and results of this surgery necessarily are subjective. Still, there are a number of investigative avenues open to us, and our cumulative experience shows no reluctance on the part of plastic surgeons to initiate further studies.