Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects

Study Overview
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Brief Summary
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A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.

Detailed Description
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This was an observational, multicenter study conducted to investigate the long term follow-up of subjects who had been exposed to study drug (either SKY0402, bupivacaine HCl, or both) in prior SKY0402 breast augmentation studies. Specifically, the protocol was designed to elicit any changes in the response of the silicone shell of the implant after exposure to study drug.

Official Title
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An Observational Study to Assess the Long-Term Follow-Up of Subjects Who Had Participated in SKY0402 Breast Augmentation Studies

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Questionnaire and Physical Exam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in either Pacira SKY0402-C-210 or Pacira SIMPLE Breast Augmentation 315 and received a dose of SKY0402, bupivacaine HCl, or both Able and willing to comply with all study visits and procedures. Able to speak, read, and understand the language of the informed consent, and any other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to study assessments. Able and willing to provide written informed consent Exclusion Criteria: Did not receive study drug in either Pacira SKY0402-C-210 or SIMPLE Breast Augmentation 315. Has a clinically significant systemic or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bupivacaine and low dose SKY0402<br> | Drug: Questionnaire and Physical Exam<br>* A 10-question survey and a six-item physical exam were completed.<br>|
| Bupivacaine and high dose SKY0402<br> | Drug: Questionnaire and Physical Exam<br>* A 10-question survey and a six-item physical exam were completed.<br>|
| Bupivacaine<br> | Drug: Questionnaire and Physical Exam<br>* A 10-question survey and a six-item physical exam were completed.<br>|
| High dose SKY0402<br> | Drug: Questionnaire and Physical Exam<br>* A 10-question survey and a six-item physical exam were completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Breast Implant Rupture | Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty | 12 to 24 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmentation mammoplasty, Breast augmentation, Postoperative pain, Analgesia