Autopsy report · NCT01785069

Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

“There was no indication that long-term follow-up would differ between any of the studies that have evaluated devices within the 410 Style Matrix.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month after it had already started.
• Ran for about 3 years before it stopped.
• 355 participants enrolled.
• Results were posted on the registry 4 years 7 months after it ended.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Allergan

Sponsor type

Industry

Conditions

Breast Augmentation; Breast Reconstruction; Breast Implant Revision

Interventions

Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection

Participants

355

Sites

29

Countries

United States

Trials that died the same way

• PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty
  “Study terminated as CE marks of the devices used have not been renewed.” (57% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.