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

Pacira Pharmaceuticals, Inc94 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Postoperative Pain

Interventions

Questionnaire and Physical ExamDRUG

A 10-question survey and a six-item physical exam were completed.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 12 to 24 months post surgery

Data from ClinicalTrials.gov

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