Breast AugmentationNCT01870869
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
A study testing Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection in people with Breast Augmentation and Breast Reconstruction, run by Allergan at 58 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- What is being tested?
- Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,951 participants
- Where
- 58 sitesUnited States
- Study dates
- 29 May 2013to 30 Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
James Namnoum
Atlanta, Georgia, 30342
Gavin Dry
Bellevue, Washington, 98005
Peter Hyans
Berkeley Heights, New Jersey, 07922
Anthony Griffin
Beverly Hills, California, 90211
Laurence Berkowitz
Campbell, California, 95008
Janet Turkle
Carmel, Indiana, 46290
Charles Nathan
Chesterfield, Missouri, 63005
Herluf Lund Jr.
Chesterfield, Missouri, 63005
Raymond Isakov
Cleveland, Ohio, 44195
Tad Heinz
Colorado Springs, Colorado, 80909
Patricia McGuire
Creve Coeur, Missouri, 63141
William Carpenter
Dallas, Texas, 75246
Gary Snider
Denver, Colorado, 80218
Peter Johnson
Des Plaines, Illinois, 60016
Stephen Madry
Elk Grove Village, Illinois, 60007
Terrence Murphy
Englewood, Colorado, 80113
Mark Jewell
Eugene, Oregon, 97401
Orlando De Lucia
Farmington, Connecticut, 06032
Isaac Starker
Florham Park, New Jersey, 07932
Bradley Bengtson
Grand Rapids, Michigan, 49503
John Renucci
Grand Rapids, Michigan, 49503
Schuyler Meltis
Hannibal, Missouri, 63401
Jeffrey Friedman
Houston, Texas, 77030
Bruce Van Natta
Indianapolis, Indiana, 46290
Christine Kelley-Patteson
Indianapolis, Indiana, 46290
Peter Hetzler
Little Silver, New Jersey, 07739
Mary Powers
Long Beach, California, 90806
Julene Samuels
Louisville, Kentucky, 40241
Gloria Duda
McLean, Virginia, 22101
Steven Morris
Midland, Michigan, 48640
Timothy Mickel
Monroe, Louisiana, 71201
Kristina D. O'Shaughnessy
Nashville, Tennessee, 37203
Patrick Maxwell
Nashville, Tennessee, 37212
Lloyd Gayle
New York, New York, 10021
John Sherman
New York, New York, 10028
Tracy Pfeifer
New York, New York, 10028
Derek Shadid
Oklahoma City, Oklahoma, 73134
Robert Hein
Oklahoma City, Oklahoma, 73134
Brad Storm
Olathe, Kansas, 66061
Perry Johnson
Omaha, Nebraska, 68102
Perry Johnson
Omaha, Nebraska, 68118
Roy Hong
Palo Alto, California, 94301
Natan Yaker
Plano, Texas, 75093
Eric Bachelor
Pleasanton, California, 94566
Robert Jacobs
Port Jefferson Station, New York, 11776
Marc Alan Drimmer
Princeton, New Jersey, 08540
Douglas Reavie
San Diego, California, 92128
Steven Teitelbaum
Santa Monica, California, 90404
Caroline Glicksman
Sea Girt, New Jersey, 08750
Paul Davis
Shreveport, Louisiana, 71105
John Lettieri
Spartanburg, South Carolina, 29303
John Decorato
Staten Island, New York, 10306
Lewis Berger
Tampa, Florida, 33607
Gerard Mosiello
Tampa, Florida, 33647
Craig Colville
Toledo, Ohio, 43615
Frank Barone
Toledo, Ohio, 43623
William Adams
University Park, Texas, 75205
Allen Gabriel
Vancouver, Washington, 98664
About this study
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.
- Being tested
- Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projectionDevice
Also called NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)
Surgical implant
| Study group | Role | What they receive |
|---|---|---|
| Augmentation | Experimental | Women who had breast augmentation with NATRELLE® 410 implants. Receives: Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection |
| Reconstruction | Experimental | Women who had breast reconstruction with NATRELLE® 410 implants. Receives: Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection |
| Revision-Augmentation | Experimental | Women who had revision of previous breast augmentation with NATRELLE® 410 implants. Receives: Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection |
| Revision-Reconstruction | Experimental | Women who had revision of previous breast reconstruction with NATRELLE® 410 implants. Receives: Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants According to Investigator Satisfaction With Implants
The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Measured: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Percentage of Participants According to Participant Satisfaction With Implants
The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Measured: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Secondary outcomes (3)
Percentage of Participants With Local Complications
Kaplan-Meier risk rates (estimation of the percentage of participants) of developing local complications is presented. Local complications collected in the study were: Asymmetry, Breast pain, Capsular contracture, Delayed wound healing, Fluid accumulation/seroma, Hematoma, Hypertrophic scarring/other abnormal scarring, Implant extrusion, Implant malposition, Implant palpability/visibility, Implant rupture, Infection, Redness, Skin rash, Swelling, Tissue/skin necrosis, Upper pole fullness, Wrinkling/rippling and Other complications .
Measured: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Percentage of Participants With Reoperations
Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Measured: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Percentage of Participants With Implant Removal With or Without Replacement
Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement is reported.
Measured: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study start29 May 2013
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,951 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Schumacher, Study chair, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870869
- Sponsor's protocol ID
- 410CAXL-001
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2013
- Last updated
- 22 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
- ClinicalTrials.gov ID
- NCT01870869
- Acronym / sponsor ID
- 410CAXL-001
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 1,951 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 29 May 2013 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Posted 22 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Augmentation | Experimental | Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projectionWomen who had breast augmentation with NATRELLE® 410 implants. |
| Reconstruction | Experimental | Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projectionWomen who had breast reconstruction with NATRELLE® 410 implants. |
| Revision-Augmentation | Experimental | Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projectionWomen who had revision of previous breast augmentation with NATRELLE® 410 implants. |
| Revision-Reconstruction | Experimental | Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projectionWomen who had revision of previous breast reconstruction with NATRELLE® 410 implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Has adequate tissue available to cover implants
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projectionAlso: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)Surgical implant | Device | Augmentation, Reconstruction, Revision-Augmentation, Revision-Reconstruction |
Primary outcome
Percentage of Participants According to Investigator Satisfaction With Implants
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Percentage of Participants According to Participant Satisfaction With Implants
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
3 secondary outcomes
Percentage of Participants With Local Complications
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Percentage of Participants With Reoperations
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Percentage of Participants With Implant Removal With or Without Replacement
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Schumacher study chair
Allergan
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection in people with Breast Augmentation and Breast Reconstruction, run by Allergan at 58 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants According to Investigator Satisfaction With Implants (time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.