TerminatedNot Applicable

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

Stopped: 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.

United States355 participantsStarted 2012-12-10

Plain-language summary

This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.

Who can participate

Age range18 Years

SexFEMALE

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 (i.e., no previous breast implant surgery) indicated for subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
✓. Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when the permanent implants are placed in the reconstructed breast)
✓. Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants

What they're measuring

Percentage of Participants According to Investigator Satisfaction With Implants

Timeframe: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Percentage of Participants According to Participant Satisfaction With Implants

Timeframe: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Trial details

NCT IDNCT01785069

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11-30

Results submitted2020-05-13

View on ClinicalTrials.gov More Breast Augmentation trials

Who can participate

Age range18 Years

SexFEMALE

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 (i.e., no previous breast implant surgery) indicated for subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
✓. Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when the permanent implants are placed in the reconstructed breast)
✓. Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants

What they're measuring

Percentage of Participants According to Investigator Satisfaction With Implants

Timeframe: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Percentage of Participants According to Participant Satisfaction With Implants

Timeframe: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)