Dataset Information

Lactation Outcomes in More Than 3500 Women Following Primary Augmentation: 5-Year Data From the Breast Implant Follow-Up Study.

ABSTRACT: BACKGROUND:Women with breast implants may have concerns about their ability to successfully breast-feed. The Breast Implant Follow-up Study (BIFS-001) is a large, 10-year observational study evaluating the performance and safety of Natrelle round silicone gel-filled breast implants. OBJECTIVES:This analysis compared lactation outcomes in women enrolled in BIFS-001 who gave birth after they underwent primary augmentation with Natrelle round silicone implants or saline implants. METHODS:At baseline and annually after surgery (>5-year visit window), patients completed questionnaires regarding pregnancy and lactation. Comparisons were made using summary statistics and odds ratios with 90% confidence intervals (OR [90% CI]). RESULTS:A total of 4679 subjects gave birth at least once after primary augmentation for a total of 5736 live births during the study (silicone, 3695 births; saline, 2041 births). Of these, 3715 (79.4%) women breast-fed at least 1 child, resulting in 80.0% (silicone) and 75.9% (saline) of babies being breast-fed. The most common complication was insufficient milk production, which was reported for 19.6% (silicone) and 19.8% (saline) of single births (OR, 0.94 [0.83, 1.06]). Complications occurred at similar rates in each group when evaluated by incision type, implant size, pocket location, and age. CONCLUSIONS:In this large group of women who gave birth after primary breast augmentation with Natrelle round silicone implants or saline implants, most were able to breast-feed their infants without complications. Lactation complications were comparable between the silicone and saline cohorts, and the incidence was comparable to reports in the general population of women who breast-feed. LEVEL OF EVIDENCE: 2:

SUBMITTER: Jewell ML

PROVIDER: S-EPMC6624791 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Lactation Outcomes in More Than 3500 Women Following Primary Augmentation: 5-Year Data From the Breast Implant Follow-Up Study.

Jewell Mark L ML Edwards Michael C MC Murphy Diane K DK Schumacher Andrew A

Aesthetic surgery journal 20190701 8

<h4>Background</h4>Women with breast implants may have concerns about their ability to successfully breast-feed. The Breast Implant Follow-up Study (BIFS-001) is a large, 10-year observational study evaluating the performance and safety of Natrelle round silicone gel-filled breast implants.<h4>Objectives</h4>This analysis compared lactation outcomes in women enrolled in BIFS-001 who gave birth after they underwent primary augmentation with Natrelle round silicone implants or saline implants.<h4> ...[more]

PMID: 30165661

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Project description:BackgroundMore personalized implant designs for total knee arthroplasty might optimize the clinical outcome after surgery. One of these personalized implant designs is the Persona knee implant system (Zimmer Biomet, Warsaw, Indiana, USA). The primary objective of this study was to determine patient reported outcomes and implant survivorship of the Persona Knee system used in primary total knee arthroplasty, up to two years after surgery.MethodsFrom November 2013 to July 2016 consecutive patients undergoing primary total knee arthroplasty were enrolled in a prospective observational cohort study at three centers. Preoperatively, at 6 weeks, 6 months, 1 and 2 years after surgery, patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), the Knee Society Score (KSS, 2011, modified version) and the EQ-5D. Adverse Events were captured, assessed for relationship to device, and recorded in the study database. Furthermore, physical functioning was assessed by the orthopedic surgeon. Repeated measures analyses were performed on PROM scores. Kaplan Meier was used to calculate survivorship of the Persona Knee Implant System.ResultsA total of 146 total knee arthroplasties were performed. 61% (89/146) of the patients were female and mean age was 64.7 (± 6.9) years. Two years after surgery, one patient had a revision of the polyethylene insert because of a periprosthetic joint infection. Therefore, the Kaplan-Meier survival estimate at 2 years was 0.99 (0.95-1.00 95% CI). OKS increased from 22.1 (95% CI 20.9-23.3) to 41.8 (95% CI 40.6-43.1) two years after surgery. Furthermore, all other PROMs also increased from before surgery to 2 year postoperatively.ConclusionThe Persona Knee implant is safe and effective and the clinical results up to two years after surgery are promising. PROMs results are very good; pain, function and quality of life all improved greatly after TKA. Further studies are needed to determine the long term clinical performance of the Persona prosthesis.Trial registrationClinicaltrials.gov ( NCT02337244 ). Registered June 1st, 2015. Retrospectively registered.

Project description:BackgroundSubstantial complication rates after postmastectomy breast reconstruction (BR) in breast cancer patients have been reported. Few studies have reported on the resulting psychological distress (PD) and satisfaction with the aesthetic result in relation to postoperative complications after completion of implant or DIEP flap BR. The present study investigated whether women were able to recover from complication related distress in the long term.MethodsPD was prospectively measured using questionnaires regarding anxiety, depression and cancer distress. Eligible patients completed questionnaires before BR (T0, n = 144), after one month (T1, n = 139) and after completion of BR, approximately 21 months after initial reconstructive surgery (T2, n = 119). Satisfaction with the aesthetic result was assessed 21 months after BR. Data concerning complications, subsequent additional surgery and total reconstruction failure up to T2 were collected from the medical records. Analyses were performed using multi-level regression analyses correcting for age.ResultsOne or more complications occurred in 61 patients (42%) and 50 women required subsequent surgery (35%). In time, mean PD significantly declined towards baseline scores independent of complications. However, a total reconstruction failure (n = 10) was significantly associated with a large temporary increase in depression scores. After additional surgery due to complications patients were less satisfied with aesthetic outcome, although patient satisfaction was independent of PD.ConclusionsPD outcomes generally declined to normal levels after completion of the entire BR course. Patients experiencing a total reconstruction failure reported more depression after this loss, but in the long term recovered to the same level as women without complications. These findings indicate that women generally can cope efficiently with these serious adverse events, even if they were less satisfied with the aesthetic result.

Dataset Information

Lactation Outcomes in More Than 3500 Women Following Primary Augmentation: 5-Year Data From the Breast Implant Follow-Up Study.

Publications

Lactation Outcomes in More Than 3500 Women Following Primary Augmentation: 5-Year Data From the Breast Implant Follow-Up Study.

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