proof of safety of the Style 410 silicon breast implants
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
n.a.
Secondary outcome
n.a.
Background summary
control of the integrity of Style 410 silicon breast implants
Study objective
proof of safety of the Style 410 silicon breast implants
Study design
patients with Style 410 silicon breast implants implanted between 1995 and 1999
get both a physical and MRI check of the breasts.
Study burden and risks
none
146 Impasse du Pont
30000 Nimes
Frankrijk
146 Impasse du Pont
30000 Nimes
Frankrijk
Listed location countries
Age
Inclusion criteria
women who were implanted in 1995-1999 with McGan Medical Silicone-Filled breast omplants Styles 410 and still have at least one of those original implants
patients must be willing to undergo a MRI-scan. Patients must be eligible for MRI
Patients must hcommit to following study requirements and must have signed and dated the Informed Consent prior to any study procedures being performed
Exclusion criteria
patient is pregnant or nursing
patient has any type of implanted material or metal devices that may make her ineligible for MRI
patient has a history of severe claustrophobia that may make her ineligible for MRI
patient only had other implants that McGhan Style 410
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15984.094.07 |