A Long-Term Study of Outcomes, Complications, and Patient Satisfaction with Breast Implants

Handel, Neal; Cordray, Tracy; Gutierrez, Jaime; Ja, Jensen

doi:10.1097/01.prs.0000201457.00772.1d

Cited by 416 publications

(227 citation statements)

References 69 publications

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“…23 Patients who had a history of prior cosmetic augmentation and/or postmastectomy reconstruction were asked to complete an ad hoc (nonvalidated) questionnaire. Of the 853 patients administered the questionnaire, 429 (approximately 50%) responded.…”

Section: Discussionmentioning

confidence: 99%

Patient satisfaction with postmastectomy breast reconstruction

McCarthy¹,

Klassen²,

Cano³

et al. 2010

Cancer

116

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BACKGROUND. At a time when the safety and effectiveness of breast implants remains under close scrutiny, it is important to provide reliable and valid evidence regarding patient outcomes. In the setting of postmastectomy reconstruction, patient satisfaction and quality of life may be the most significant outcome variables when evaluating surgical success. The objective of the current study was to identify predictors of patient satisfaction with breast appearance, including implant type, in a large sample of women who underwent breast reconstruction surgery using implants. METHODS. A multicenter, cross-sectional study design was used. A total of 672 women who had completed postmastectomy, implant-based reconstruction at 1 of 3 centers in North America were asked to complete the BREAST-Q (Reconstruction Module). Multivariate linear regression modeling was performed. RESULTS. Completed questionnaire data were available for 482 of the 672 patients. In 176 women, silicone implants were placed and in 306, saline implants were used. The multivariate model confirmed that patients' satisfaction with their breasts was significantly higher in patients with silicone implants (P ¼ .016). The receipt of postmastectomy radiotherapy was found to have a significant, negative effect on breast satisfaction (P<.000) in both silicone and saline implant recipients. In addition, for women who received either silicone or saline implants, satisfaction diminished over time (P ¼ .017). CONCLUSIONS. In the setting of postmastectomy reconstruction, patients who received silicone breast implants reported significantly higher satisfaction with the results of reconstruction than those who received saline implants. This information can be used to optimize shared medical decision-making by providing patients with realistic postoperative expectations. Cancer 2010;116:5584-91.

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Section: Discussionmentioning

confidence: 99%

Patient satisfaction with postmastectomy breast reconstruction

McCarthy¹,

Klassen²,

Cano³

et al. 2010

Cancer

116

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“…The infection rate of 0.08% in the current study was lower than infection rates observed after permanent implants (13)(14)(15). Prophylactic antibiotics were not used before injection of Macrolane.…”

Section: Infectionmentioning

confidence: 52%

Complications and management of breast enhancement using hyaluronic acid

Ishii¹,

Sakata²

2014

CAN J PLAST SURG

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“…The risk of this complication increases over time [9][10][11] and is reflected in the slightly increased capsular contracture rates reported herein from 6 years to 10 years. 3 However, the 10-year rates (9.2%, 11.9%, 14.5%, and 26.8% for the augmentation, augmentation revision, reconstruction, and reconstruction revision cohorts, respectively) are lower than those observed in the Natrelle round gel (fourth generation) core study, which included predominately smooth implants (56.2%).…”

Section: Discussionmentioning

confidence: 85%

Ten-year results from the natrelle® 410 anatomical form stable silicone breast implant core study

Maxwell

Natta

Bengtson

et al. 2014

Journal of Plastic, Reconstructive & Aesthetic Surgery

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Background: Silicone breast implants have long been used for breast augmentation and reconstruction. During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome performance. Objectives: The authors conducted a 10-year study to determine the safety and effectiveness of Natrelle 410 silicone breast implants. Methods: This prospective, multicenter study enrolled 941 subjects who were undergoing either augmentation, augmentation revision, reconstruction, or reconstruction revision. Data on complications, reoperations, explantations, and subject satisfaction were collected at annual clinic visits, and one-third of subjects underwent biennial magnetic resonance imaging (MRI) to screen for implant rupture. The authors used the Kaplan-Meier estimator to calculate risk rates for local complications, reoperations, and explantations. Results: Capsular contracture rates increased approximately 1% per year from the previously reported 6-year rates. The rates were significantly lower than those from the Natrelle round gel core study. The overall rate of confirmed ruptured implants in subjects who underwent MRI was 5.7%. Eleven late seromas were reported. The most common reason for explantation was a subject requesting a size or style change. Satisfaction rates remained high through 10 years, with most subjects saying they were somewhat or definitely satisfied with their implants. Conclusions: This 10-year prospective trial demonstrated the long-term safety and effectiveness of Natrelle 410 anatomical form-stable implants. The complication rates were low and the satisfaction rates were high.

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A Long-Term Study of Outcomes, Complications, and Patient Satisfaction with Breast Implants

Cited by 416 publications

References 69 publications

Patient satisfaction with postmastectomy breast reconstruction

Patient satisfaction with postmastectomy breast reconstruction

Complications and management of breast enhancement using hyaluronic acid

Ten-year results from the natrelle® 410 anatomical form stable silicone breast implant core study

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