Dataset Information

What can we learn from sonication results of breast implants?

ABSTRACT:

Background

Different research groups have identified microorganisms on breast implants by sonication with significant correlation to the rate of capsular contracture. This substantiated the hypothesis of an infectious etiology of capsular contracture. However, no clinical consequence has been drawn from these results yet. Aim of this study was to review sonication results from breast implants and to evaluate the current preoperative antibiotic regime for breast-implant surgery.

Methods

We compared breast implant sonication culture results from published reports and our own database. Current perioperative antibiotic recommendations were compared with the susceptibility profile of the found organisms.

Results

We found Coagulase-negative staphylococci and Propionibacteria to be the main group of microorganism found by sonication on explanted breast implants. Most guidelines recommend cephalosporins for preoperative antibiotical prophylaxis for breast-implant surgery.

Conclusion

There is a discrepancy between antibiotic activity of commonly used antibiotics for preoperative prophylaxis of surgical site infections, and microorganisms found by sonication on breast implants, suspected to trigger the formation of capsular contracture. A targeted antibiotic prophylaxis for breast implant surgery with glycopeptides (e.g. Vancomycin) should be considered for the prevention of capsular contracture.

SUBMITTER: Reischies FMJ

PROVIDER: S-EPMC5552211 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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What can we learn from sonication results of breast implants?

Reischies Frederike M J FMJ Krause Robert R Holzer Judith J Tiefenbacher Fabian F Winter Raimund R Eylert Gertraud G Meikl Tobias T Tuca Alexandru A Köfer Martin J MJ Kamolz Lars P LP Lumenta David B DB

PloS one 20170810 8

<h4>Background</h4>Different research groups have identified microorganisms on breast implants by sonication with significant correlation to the rate of capsular contracture. This substantiated the hypothesis of an infectious etiology of capsular contracture. However, no clinical consequence has been drawn from these results yet. Aim of this study was to review sonication results from breast implants and to evaluate the current preoperative antibiotic regime for breast-implant surgery.<h4>Method ...[more]

PMID: 28797044

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Project description:BACKGROUND:Sonication is a valuable tool in the diagnosis of periprosthetic joint infections (PJI). However, conditions and definition criteria for PJI vary among studies. The aim of this study was to determine the diagnostic performance (i.e., specificity, sensitivity) of sonicate fluid culture (SFC) against periprosthetic tissue culture (PTC), when using European Bone and Joint Infection Society (EBJIS) criteria. METHODS:From March 2017 to April 2018, 257 implants were submitted for sonication. PJI was defined according to the EBJIS criteria as well as according to the International Consensus Meeting criteria of 2018 (ICM 2018). Only cases with at least one corresponding tissue sample were included. Samples were cultured using traditional microbiological plating techniques. Sensitivity and specificity were determined using two-by-two contingency tables. McNemar's test was used to compare proportions among paired samples. Subgroup analysis was performed dividing the cohort according to the site of PJI, previous antibiotic treatment, and time of manifestation. Prevalence of pathogens was determined for all patients as well as for specific subgroups. RESULTS:Among the 257 cases, 145 and 112 were defined as PJI and aseptic failure, respectively. When using the EBJIS criteria, the sensitivity of SFC and PTC was 69.0 and 62.8%, respectively (p =?.04). Meanwhile, the specificity was 90.2 and 92.9%, respectively (p =?.65). When adopting ICM 2018 criteria, the sensitivity of SFC and PTC was 87.5 and 84.4% (p =?.63) respectively, while the specificity was 85.1 and 92.5% (p =?.05), respectively. The most commonly identified pathogens were coagulase-negative staphylococci (26% overall), while 31% of PJI were culture-negative and 9% polymicrobial. CONCLUSIONS:SFC exhibited significantly greater sensitivity versus PTC when using the EBJIS criteria. Nevertheless, the diagnosis of PJI remains a difficult challenge and different diagnostic tools are necessary to optimize the outcome.

Project description:BackgroundMentor MemoryGel Breast Implants were approved by the U.S. Food and Drug Administration in November of 2006. Patients in the Core clinical study supporting this approval were followed for 10 years.MethodsThis prospective, multicenter, clinical study included primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction patients implanted with smooth or Siltex Texture MemoryGel Implants. Incidence, severity, and method of resolution for all postoperative complications were assessed on per-patient and per-implant bases. The primary effectiveness endpoints were overall mean change in chest circumference and bra cup size following the implantation procedure.ResultsPrimary augmentation (n = 552), revision augmentation (n = 145), primary reconstruction (n = 251), and revision reconstruction (n = 60) patients were enrolled in the study. Kaplan-Meier estimated 10-year cumulative incidence rates for key complications at the subject level for Baker grade III/IV capsular contracture were as follows: primary augmentation, 12.1 percent; revision augmentation, 24.4 percent; primary reconstruction, 20.5 percent; and revision reconstruction, 36.9 percent. For infection, rates were as follows: primary augmentation, 1.6 percent; revision augmentation, 1.4 percent; primary reconstruction, 6.2 percent; and revision reconstruction, 0 percent. For explantation with or without replacement, rates were as follows: primary augmentation, 11.6 percent; revision augmentation, 24.1 percent; primary reconstruction, 33.4 percent; and revision reconstruction; 37.8 percent. For rupture, rates were as follows: primary augmentation, 24.2 percent; revision augmentation, 23.7 percent; primary reconstruction, 32.7 percent; and revision reconstruction, 38.7 percent. For any reoperation, rates were as follows: primary augmentation, 25.5 percent; revision augmentation, 43.6 percent; primary reconstruction, 49.0 percent; and revision reconstruction, 50.7 percent.ConclusionThe results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction.Clinical question/level of evidenceTherapeutic, IV.

Project description:BackgroundDue to an ageing population and demographic changes worldwide, a higher prevalence of heart disease is forecasted, which causes an even higher demand for cardiac implants in future. The increasing high incidence of clinical adverse events attributed especially to high-risk medical devices has led an advocated change from many stakeholders. This holds especially true for devices like cardiac implants, with their high-risk nature and high complication rates associated with considerable mortality, due to their frequent use in older populations with frequent co-morbidities. To ensure patients' safety, the objective of this study is to analyze different cardiac implants recall reasons and different recall systems, based on an overview of the recalls of cardiac implant medical devices in the last decade. On the basis of the results from this structured analysis, this study provides recommendations on how to avoid such recalls from a manufacturer perspective, as well as how to timely react to an adverse event from a post-surveillance system perspective.Methods and findingsA systematic search of cardiac implant recalls information has been performed in the PubMed, ScienceDirect and Scopus databases, as well as data sources in regulatory authorities from 193 UN Member States. Data has been extracted for the years 2004-2014 with the following criteria applied: cardiac implant medical device recalls and reasons for recall, associated harm or risk to patients. From the data sources described above, eleven regulatory authorities and 103 recall reports have been included in this study. The largest cardiac implant categories include ICDs 40.8%, pacemakers 14.5% and stents 14.5%. Regarding the recall reasons, the majority of reports were related to device battery problems (33.0%) and incorrect therapy delivery (31.1%). From a total of 103 recall reports, five reported death and serious injuries. Our review highlights weaknesses in the current cardiac implant recall system, including data reporting and management issues and provides recommendations for the improvement of safety information and management.ConclusionDue to the mortality associated with the nature of cardiac implants, the traceability and transparency of safety hazards information is crucial. By a structured analysis of recall reasons and their efficient management, important knowledge is gained to inform an effective safety-reporting system for monitoring the safety of cardiac implanted patients, ideally by building up cardiac implant registries worldwide in the future.

Dataset Information

What can we learn from sonication results of breast implants?

Background

Methods

Results

Conclusion

Publications

What can we learn from sonication results of breast implants?

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