N/A
N=94
Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01076686 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Number of Subjects With Breast Implant Rupture — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Questionnaire and Physical Exam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pacira Pharmaceuticals, Inc
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Breast Implant Rupture |
0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01076686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.