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Aesthetic Surgery Journal May 2021Results from the MemoryGel Breast Implants Core Clinical Study suggest these devices are safe and effective at 10 years after implantation. Although clinical trials are...
BACKGROUND
Results from the MemoryGel Breast Implants Core Clinical Study suggest these devices are safe and effective at 10 years after implantation. Although clinical trials are essential for measuring the safety and effectiveness of a device, real-world evidence can supplement clinical trials by providing information on outcomes observed in diverse clinical settings for a more heterogeneous population, without fixed treatment patterns, and without continuous patient monitoring, such that follow-up is more representative of normal clinical practice.
OBJECTIVES
The aim of this study was to measure real-world outcomes, including safety and effectiveness, in patients who underwent primary breast augmentation with smooth MemoryGel implants.
METHODS
This was a case series looking at patients, age 22 years and older, who underwent primary breast augmentation at a single site between December 2006 and December 2016 and who had a minimum of 2 years of follow-up. Descriptive statistics were used to summarize baseline characteristics and outcomes. Kaplan-Meier models were used to estimate safety outcomes for capsular contracture (Baker grade III/IV), infection, and rupture.
RESULTS
A total of 50/777 (6.4%) patients reported a complication, with an average time to complication of 3.9 years (range, 19 days-11.8 years) postprocedure. Kaplan-Meier estimates of the 10-year cumulative incidence of capsular contracture (Baker grade III/IV), infection, and rupture were 4.7%, 0.1%, and 1.6%, respectively.
CONCLUSIONS
Analyses of a large population from a single site provide further support for the long-term safety and effectiveness of MemoryGel breast implants in a primary augmentation cohort.
Topics: Adult; Breast; Breast Implantation; Breast Implants; Follow-Up Studies; Humans; Mammaplasty; Prosthesis Design; Silicone Gels; Young Adult
PubMed: 33647937
DOI: 10.1093/asj/sjaa388 -
Revista Da Associacao Medica Brasileira... 2023The breasts are symbols of femininity, sexuality, and maternity. Breast augmentation is among the most sought-after procedures for women and has a positive impact on...
INTRODUCTION
The breasts are symbols of femininity, sexuality, and maternity. Breast augmentation is among the most sought-after procedures for women and has a positive impact on quality of life. Sexuality is one of the items that contribute to increased quality of life. Surgical outcomes can be evaluated from the patients' perspective using developed and validated questionnaires. For the assessment of sexuality, the most commonly used instruments are the Female Sexual Quotient and the Female Sexual Function Index, which estimate several domains of sexuality and can be used to evaluate the impact of surgery on it.
OBJECTIVE
The objective of this study was to evaluate the impact of breast augmentation on female sexuality.
METHODS
We selected 87 patients from the Plastic Surgery Outpatient Clinic of Hospital São Paulo (Federal University of São Paulo) who wished to undergo breast augmentation. The patients were classified into two groups: the Female Sexual Quotient questionnaire was applied to one group, and the Female Sexual Function Index questionnaire was applied to the other group to evaluate sexuality preoperatively as well as at 2 and 4 months postoperatively.
RESULTS
In both groups, there was a significant increase in the total score of the Female Sexual Quotient and Female Sexual Function Index questionnaires, and an individual increase in each domain assessed, with a significant increase in the domains of orgasm and sexual satisfaction, as well as foreplay and arousal, indicating an improvement in the patients' sexuality postoperatively.
CONCLUSION
Breast augmentation has a positive impact on female sexuality; furthermore, the Female Sexual Quotient and Female Sexual Function Index are sensitive in detecting this impact.
Topics: Pregnancy; Female; Humans; Quality of Life; Brazil; Mammaplasty; Sexuality; Sexual Behavior; Surveys and Questionnaires
PubMed: 37556624
DOI: 10.1590/1806-9282.2023S105 -
Breast (Edinburgh, Scotland) Apr 2021Innovations in 3D spatial technology and augmented reality imaging driven by digital high-tech industrial science have accelerated experimental advances in breast cancer...
INTRODUCTION
Innovations in 3D spatial technology and augmented reality imaging driven by digital high-tech industrial science have accelerated experimental advances in breast cancer imaging and the development of medical procedures aimed to reduce invasiveness.
PRESENTATION OF CASE
A 57-year-old post-menopausal woman presented with screen-detected left-sided breast cancer. After undergoing all staging and pre-operative studies the patient was proposed for conservative breast surgery with tumor localization. During surgery, an experimental digital and non-invasive intra-operative localization method with augmented reality was compared with the standard pre-operative localization with carbon tattooing (institutional protocol). The breast surgeon wearing an augmented reality headset (Hololens) was able to visualize the tumor location projection inside the patient's left breast in the usual supine position.
DISCUSSION
This work describes, to our knowledge, the first experimental test with a digital non-invasive method for intra-operative breast cancer localization using augmented reality to guide breast conservative surgery. In this case, a successful overlap of the previous standard pre-operative marks with carbon tattooing and tumor visualization inside the patient's breast with augmented reality was obtained.
CONCLUSION
Breast cancer conservative guided surgery with augmented reality can pave the way for a digital non-invasive method for intra-operative tumor localization.
Topics: Augmented Reality; Breast Neoplasms; Female; Humans; Imaging, Three-Dimensional; Magnetic Resonance Imaging; Mammaplasty; Middle Aged; Surgery, Computer-Assisted
PubMed: 33548617
DOI: 10.1016/j.breast.2021.01.004 -
Aesthetic Surgery Journal Nov 2015Breast augmentation and reconstruction mammaplasty have been in practice for decades and are highly prevalent surgeries performed worldwide. While overall patient... (Comparative Study)
Comparative Study Review
Breast augmentation and reconstruction mammaplasty have been in practice for decades and are highly prevalent surgeries performed worldwide. While overall patient satisfaction is high, common long-term effects include breast tissue atrophy, accelerated ptosis and inframammary fold breakdown. Increasing evidence attributes these events to the durative loading and compressive forces introduced by the breast implants. Mechanical challenges exceeding the elastic capacity of the breast tissue components, eventually lead to irreversible tissue stretching, directly proportional to the introduced mass. Thus, it is suggested that, contrary to long-standing dogmas, implant weight, rather than its volume, stands at the basis of future tissue compromise and deformation. A novel lightweight implant has been developed to address the drawbacks of traditional breast implants, which demonstrate equivalence between their size and weight. The B-Lite(®) breast implant (G&G Biotechnology Ltd., Haifa, Israel) design allows for a reduction in implant weight of up to 30%, while maintaining the size, form, and function of traditional breast implants. The CE-marked device can be effectively implanted using standard of care procedures and has been established safe for human use. Implantation of the B-Lite(®) breast implant is projected to significantly reduce the inherent strains imposed by standard implants, thereby conserving tissue stability and integrity over time. In summary, this novel, lightweight breast implant promises to reduce breast tissue compromise and deformation and subsequent reoperation, further improving patient safety and satisfaction.
Topics: Adult; Aged; Breast Implantation; Breast Implants; Esthetics; Female; Follow-Up Studies; Humans; Mammaplasty; Middle Aged; Prosthesis Design; Prosthesis Failure; Risk Assessment; Treatment Outcome; Weights and Measures
PubMed: 26333989
DOI: 10.1093/asj/sjv080 -
Plastic Surgery (Oakville, Ont.) Aug 2023The rate of opioid prescribing after low-risk surgical procedures has increased over the past decade, and surgeons are responsible for prescribing approximately...
BACKGROUND
The rate of opioid prescribing after low-risk surgical procedures has increased over the past decade, and surgeons are responsible for prescribing approximately one-third of all opioid medications. There is additional supporting evidence that patients only consume about half of the opioids prescribed to them after outpatient plastic surgery. Currently, there is no literature to provide surgeons with reference ranges for how much opioid medication will adequately provide analgesia for patients after undergoing bilateral breast augmentation (BBA) surgery.
OBJECTIVE
To quantify the amount of opioid medication required to adequately control pain for patients after undergoing BBA and use these data to provide recommendations on opioid prescribing practices.
METHODS
Cross-sectional prospective data were obtained through a take-home medication and pain tracking questionnaire for 56 patients after they underwent either subpectoral or subglandular BBA. Patients documented their pain scores on a 0 to 10 analogue scale and documented the type and amount of pain medication they took for a 7-day period.
RESULTS
Our study demonstrated that patients in the subglandular BBA group required an average of either 25 ± 1.2 Tylenol #3 or 19.3 ± 2.3 Tramacet tablets, and the subpectoral group required 27.7 ± 1.7 Tylenol #3 or 25.6 ± 0.9 Tramacet tablets over a 7-day period. There was no statistically significant difference between the 2 surgical groups.
CONCLUSION
We propose a reference range of medication required on average for patients undergoing BBA to obtain adequate pain control in the initial postoperative period that falls within the most recent Canadian guidelines for safe opioid prescribing practices.
PubMed: 37654542
DOI: 10.1177/22925503211034828 -
American Family Physician Nov 2021Breast implants are used for a wide range of cosmetic and reconstructive purposes. In addition to breast augmentation, implants can be used for postmastectomy breast...
Breast implants are used for a wide range of cosmetic and reconstructive purposes. In addition to breast augmentation, implants can be used for postmastectomy breast reconstruction, correction of congenital breast anomalies, breast or chest wall deformities, and male-to-female top surgery. Breast implants may confer significant benefits to patients, but several factors are important to consider preoperatively, including the impact on mammography, future lactation, and potential long-term implant complications (e.g., infection, capsular contracture, rupture, and the need for revision, replacement, or removal). A fundamental understanding of implant monitoring is also paramount to implant use. Patients with silicone breast implants should undergo routine screening for implant rupture with magnetic resonance imaging or ultrasonography completed five to six years postoperatively and then every two to three years thereafter. With the exception of complications, there are no formal recommendations regarding the timing of breast implant removal or exchange. Women with unilateral breast swelling should be evaluated with ultrasonography for an effusion that might indicate breast implant-associated anaplastic large cell lymphoma. There are no specific breast cancer screening recommendations for patients with breast implants, but special mammographic views are indicated to enhance accuracy. Although these discussions are a routine component of consultation and postoperative follow-up for plastic surgeons performing these procedures, family physicians should have a working knowledge of implant indications, characteristics, and complications to better counsel their patients, to ensure appropriate screening, and to coordinate care after surgery.
Topics: Aftercare; Breast; Breast Implantation; Breast Implants; Female; Humans; Long Term Adverse Effects; Male; Mammography; Mastectomy; Postoperative Complications; Plastic Surgery Procedures; Sex Reassignment Surgery; Surgery, Plastic
PubMed: 34783490
DOI: No ID Found -
British Journal of Cancer Feb 2015Several recent papers have generated new hope about the use of white adipose tissue (WAT)-derived progenitor cells for soft tissue reconstruction in a variety of... (Review)
Review
Several recent papers have generated new hope about the use of white adipose tissue (WAT)-derived progenitor cells for soft tissue reconstruction in a variety of diseases including breast cancer (BC), a procedure that is increasingly used worldwide. We revised the available literature about WAT cells and BC. In the BC field, we believe that the hype for the exciting results in terms of WAT progenitor cell engraftment and tissue augmentation should be tempered when considering the recent and abundant preclinical studies, indicating that WAT progenitors may promote BC growth and metastasis. White adipose tissue progenitors can contribute to tumour vessels, pericytes and adipocytes, and were found to stimulate local and metastatic BC progression in several murine models. Moreover, there are clinical retrospective data showing a significant increase in the local recurrence frequency in patients with intraepithelial neoplasia who received a lipofilling procedure for breast reconstruction compared with controls. Retrospective and prospective clinical trials are warranted to investigate in depth the safety of this procedure in BC. Preclinical models should be used to find mechanisms able to inhibit the tumour-promoting activity of WAT progenitors while sparing their tissue reconstruction potential.
Topics: Adipose Tissue, White; Adult Stem Cells; Animals; Breast Neoplasms; Female; Humans; Mammaplasty; Mastectomy; Neoplasm Metastasis; Neoplasm Recurrence, Local; Risk Factors
PubMed: 25584493
DOI: 10.1038/bjc.2014.657 -
Plastic and Reconstructive Surgery Sep 2023The Ideal Implant structured breast implant uses different technology than unstructured saline or silicone gel implants, making it a third type of implant. U.S. Food and...
BACKGROUND
The Ideal Implant structured breast implant uses different technology than unstructured saline or silicone gel implants, making it a third type of implant. U.S. Food and Drug Administration (FDA) and Health Canada granted approval in November of 2014. This saline-filled implant has an internal structure consisting of a series of nested shells that support the upper pole when upright and control movement of the saline to provide a natural feel. Because women can look in the mirror to know their implants are intact, they have peace of mind. In contrast, most women are concerned about silicone gel implant ruptures, which are silent and require FDA-recommended magnetic resonance imaging or ultrasound scans for detection.
METHODS
This U.S. trial enrolled 502 women: 399 for primary and 103 for revision augmentation. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 426 (84.9%) completed 10-year follow-up visits, a higher percentage than all other FDA breast implant trials.
RESULTS
Through 10 years of follow-up, surgeon satisfaction was 94.8% for primary and 87.4% for revision augmentation; and patient satisfaction was 92.7% for primary and 82.3% for revision augmentation. Cumulative Kaplan-Meier risk rates for two major adverse events were lower than in the silicone gel implant trials: Baker class III and IV capsular contracture was 6.6% for primary and 11.5% for revision augmentation; and rupture/deflation was 3.7% for primary and 4.7% for revision augmentation.
CONCLUSION
Ten-year results from 426 women show the Ideal Implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation.
CLINICAL QUESTION/LEVEL OF EVIDENCE
Therapeutic, IV.
Topics: Female; Humans; Breast Implants; Silicone Gels; Follow-Up Studies; Breast; Breast Implantation; Reoperation; Saline Solution; Contracture; Postoperative Complications; Implant Capsular Contracture; Prosthesis Design
PubMed: 36827477
DOI: 10.1097/PRS.0000000000010312 -
Archives of Plastic Surgery May 2020This is the first clinical study conducted among Asian women using breast implants manufactured by an Asian company. Four-year data regarding the safety and efficacy of...
BACKGROUND
This is the first clinical study conducted among Asian women using breast implants manufactured by an Asian company. Four-year data regarding the safety and efficacy of BellaGel breast implants have already been published, and we now report 6-year data.
METHODS
This study was designed to take place over 10 years. It included 103 patients who underwent breast reconstruction or augmentation using BellaGel breast implants. The rates of implant rupture and capsular contracture were measured and analyzed to evaluate the effectiveness of the breast implant.
RESULTS
At patients' 6-year postoperative visits, the implant rupture and capsular contracture rates were 1.15% and 2.30%, respectively. The implant rupture rate was 3.77% among reconstruction cases and 0% among augmentation cases. The capsular contracture rate was 5.66% among reconstruction cases and 0.83% among augmentation cases.
CONCLUSIONS
The 6-year data from this planned 10-year study suggest that the BellaGel cohesive silicone gel-filled breast implant is an effective and safe medical device that can be used in breast reconstruction and augmentation.
PubMed: 32453932
DOI: 10.5999/aps.2019.01858 -
Augmentation-Mastopexy: Analysis of 95 Consecutive Patients and Critical Appraisal of the Procedure.Journal of Clinical Medicine Apr 2023Single-stage mastopexy-augmentation has been demonstrated to be a safe procedure. However, revisions may still be necessary. We evaluate 95 consecutive patients...
Single-stage mastopexy-augmentation has been demonstrated to be a safe procedure. However, revisions may still be necessary. We evaluate 95 consecutive patients undergoing mastopexy-augmentation and introduce a new surgical technique for the procedure: the modified dual plane technique. In this retrospective study, 95 patients (mean age 34 ± 11 years) underwent mastopexy-augmentation between 2009 and 2019. The procedures were classified as subglandular, dual plane, or modified dual plane technique. The outcome measures included major and minor complications. A total of 19 patients underwent a subglandular procedure, 32 patients a dual plane procedure, and 44 patients a modified dual plane procedure. We observed a high overall complication rate in the subglandular group (n = 12, 63%), dual plane group (n = 15, 47%), and modified dual plane group (n = 10, 23%). Complications leading to implant loss/change occurred in seven patients in the subglandular group (37%), six patients in the dual plane group (19%), and no patient in the modified dual plane group. While we observed a high complication rate in patients undergoing mastopexy-augmentations, the modified dual plane technique was associated with a lower complication rate.
PubMed: 37176652
DOI: 10.3390/jcm12093213