CompletedNot Applicable

Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants

France, Germany, Israel201 participantsStarted 2014-05

Plain-language summary

Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach 410 cohesive BIOCELL™ textured device (Truform 2 \& 3 only) has been implanted * Primary breast augmentation 3 to 10 years prior to data collection * Submuscular/dual plane or subglandular implant placement Exclusion Criteria: * Breast augmentation for Poland Syndrome or amastia * Breast reconstruction following mastectomy * Revision or secondary breast reconstruction * Non 410 device at initial breast augmentation * Women subsequently diagnosed with fibrocystic disease considered to be pre-malignant * Procedures of the breast not related to the primary breast augmentation (e.g. excision of skin lesions) * Axillary or peri-areolar approach * Glandular mastopexy augmentation (skin excision only)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant

Timeframe: 3 to 10 years

Trial details

NCT IDNCT02132572

SponsorAllergan

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-10

Results submitted2016-07-26

View on ClinicalTrials.gov More Breast Implantation trials