Single-Center, Long-Term Experience with Mentor Contour Profile Gel Implants: What Can We Learn after 21 Years of Follow-Up?
Abstract
[BACKGROUND] The difficulty in obtaining long-term data with the use of breast implants is well known. The majority of available data are from multicenter studies with different surgical techniques, and different implants.
[METHODS] The authors provide retrospective 10-year study data (2001 to 2011) with Mentor Contour Profile Gel implants after a mean of 13 years of follow-up, in the first single-center study of such size and length. This study included 835 patients with 1674 Mentor implants across 6 surgery types, all of them performed with a consistent surgical technique developed by the senior author (J.L.M.Y.). Long-term complication rates were analyzed. For the safety analysis, Kaplan-Meier risk rates were calculated.
[RESULTS] A total of 85% of the patients had long-term follow-up data (at least 7 years). The overall complication rate was 13.2%. The reoperation rate was 12.3%, being just 6.2% caused by complications. The 21-year Kaplan Meier cumulative incidence rate was 1.7% for capsular contracture and 5.1% for implant rupture. The periareolar approach and having a previous capsular contracture were found to be risk factors to develop a new capsular contracture. Low-height, high-projected implants had a significant higher risk of implant rotation. No breast implant-associated anaplastic large cell lymphoma or breast implant illness cases were found; 89.2% of the patients reported being satisfied or very satisfied with the surgery and the implant.
[CONCLUSION] With a consistent surgical technique, these 21-year follow-up data of the Mentor Contour Profile Gel implants reaffirm the very strong safety profile of these implants, and continued patient satisfaction with them.
[CLINICAL QUESTION/LEVEL OF EVIDENCE] Therapeutic, IV.
[METHODS] The authors provide retrospective 10-year study data (2001 to 2011) with Mentor Contour Profile Gel implants after a mean of 13 years of follow-up, in the first single-center study of such size and length. This study included 835 patients with 1674 Mentor implants across 6 surgery types, all of them performed with a consistent surgical technique developed by the senior author (J.L.M.Y.). Long-term complication rates were analyzed. For the safety analysis, Kaplan-Meier risk rates were calculated.
[RESULTS] A total of 85% of the patients had long-term follow-up data (at least 7 years). The overall complication rate was 13.2%. The reoperation rate was 12.3%, being just 6.2% caused by complications. The 21-year Kaplan Meier cumulative incidence rate was 1.7% for capsular contracture and 5.1% for implant rupture. The periareolar approach and having a previous capsular contracture were found to be risk factors to develop a new capsular contracture. Low-height, high-projected implants had a significant higher risk of implant rotation. No breast implant-associated anaplastic large cell lymphoma or breast implant illness cases were found; 89.2% of the patients reported being satisfied or very satisfied with the surgery and the implant.
[CONCLUSION] With a consistent surgical technique, these 21-year follow-up data of the Mentor Contour Profile Gel implants reaffirm the very strong safety profile of these implants, and continued patient satisfaction with them.
[CLINICAL QUESTION/LEVEL OF EVIDENCE] Therapeutic, IV.
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 해부 | breast
|
유방 | dict | 3 | |
| 합병증 | capsular contracture
|
피막구축 | dict | 3 | |
| 해부 | periareolar
|
scispacy | 1 | ||
| 합병증 | breast implant
|
scispacy | 1 | ||
| 합병증 | implant rupture
|
보형물 파열 | dict | 1 | |
| 합병증 | anaplastic large cell lymphoma
|
보형물연관 역형성대세포림프종 | dict | 1 | |
| 약물 | [BACKGROUND]
|
scispacy | 1 | ||
| 약물 | [RESULTS] A
|
scispacy | 1 | ||
| 질환 | contracture
|
C0009917
Contracture
|
scispacy | 1 | |
| 질환 | breast implant-associated anaplastic large cell lymphoma or breast implant illness
|
C4528210
Breast implant-associated anaplastic large-cell lymphoma
|
scispacy | 1 | |
| 질환 | breast implant-associated anaplastic large cell lymphoma
|
scispacy | 1 | ||
| 기타 | Gel Implants: What Can
|
scispacy | 1 | ||
| 기타 | patients
|
scispacy | 1 | ||
| 기타 | capsular
|
scispacy | 1 | ||
| 기타 | patient
|
scispacy | 1 |
MeSH Terms
Humans; Breast Implants; Female; Retrospective Studies; Follow-Up Studies; Middle Aged; Adult; Breast Implantation; Prosthesis Design; Postoperative Complications; Reoperation; Aged; Young Adult; Time Factors; Prosthesis Failure; Kaplan-Meier Estimate; Treatment Outcome
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