NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study

Stopped early · Not applicable

Conditions studied: Breast Augmentation, Breast Reconstruction, Breast Implant Revision

In brief

This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants for breast augmentation, reconstruction, or revision.

Key facts

Study ID

NCT01870869

Run by

Allergan

People needed

1951

Starts

2013-05-29

Expected to finish

2015-11-30

Last updated by the study team

2020-06-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts; or be planning to be implanted with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and meet the inclusion criteria listed below:
• Female, age 18 or older (age 22 or older for breast augmentation participants who are implanted under Protocol 410CAXL-001)
• Present with 1 or more of the following conditions:
• Primary breast augmentation (i.e., no previous breast implant surgery) indicated for participant 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 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
• Has adequate tissue available to cover implants

You may not qualify if…

• For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and did not meet the exclusion criteria listed below or plan to undergo implantation with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and does not meet the exclusion criteria listed below:
• Has an advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
• Has an existing carcinoma of the breast, without mastectomy
• Has an abscess or infection in the body at the time of enrollment
• Is pregnant or nursing
• Has any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) > 8%), that is clinically known to impact wound healing ability
• Shows tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration
• Has or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
• Shows psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
• Is not willing to undergo further surgery for revision, if medically required

Where it is running

• Laurence Berkowitz — Campbell, California, United States
• Mary Powers — Long Beach, California, United States
• Roy Hong — Palo Alto, California, United States
• Eric Bachelor — Pleasanton, California, United States
• Douglas Reavie — San Diego, California, United States
• Steven Teitelbaum — Santa Monica, California, United States
• Tad Heinz — Colorado Springs, Colorado, United States
• Gary Snider — Denver, Colorado, United States
• Terrence Murphy — Englewood, Colorado, United States
• Orlando De Lucia — Farmington, Connecticut, United States
• Lewis Berger — Tampa, Florida, United States
• Gerard Mosiello — Tampa, Florida, United States
• James Namnoum — Atlanta, Georgia, United States
• Peter Johnson — Des Plaines, Illinois, United States
• Stephen Madry — Elk Grove Village, Illinois, United States
• Janet Turkle — Carmel, Indiana, United States
• Bruce Van Natta — Indianapolis, Indiana, United States
• Christine Kelley-Patteson — Indianapolis, Indiana, United States
• Brad Storm — Olathe, Kansas, United States
• Julene Samuels — Louisville, Kentucky, United States
• Timothy Mickel — Monroe, Louisiana, United States
• Paul Davis — Shreveport, Louisiana, United States
• Bradley Bengtson — Grand Rapids, Michigan, United States
• John Renucci — Grand Rapids, Michigan, United States
• Anthony Griffin — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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