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

Postoperative Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01076686
Study type Observational
Source Pacira Pharmaceuticals, Inc
Contact
Status Completed
Phase N/A
Start date February 2010
Completion date March 2010
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