Breast AugmentationNCT00689871

Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

A study testing Natrelle(TM) Silicone-Filled Breast Implants in people with Breast Augmentation and Breast Reconstruction, run by Allergan Medical at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants. 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, Revision of Augmentation or Reconstruction
What is being tested?: Natrelle(TM) Silicone-Filled Breast Implants
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 715 participants
Where: 1 siteUnited States
Study dates: Jan 1999to Aug 2011
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

Female, age 18 years or older
Seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia, asymmetry, ptosis, or aplasia
Seeking primary breast reconstruction
Seeking breast revision-augmentation
Seeking breast revision-reconstruction
Adequate tissue available to cover implants
Patients at MRI designated sites must be willing to undergo MRI at their 1,3, 5, 7 and 9-year follow-up visits (serial MRI). The patient must be eligible for MRI (for example, no implanted metal or metal devices and no history of severe claustrophobia that may make her ineligible for MRI).

Who cannot join

Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
Existing carcinoma of the breast, without mastectomy
Abscess or infection in the body at the time of enrollment
Pregnant or nursing
Have any disease, including uncontrolled diabetes (e.g., HbAIc > 8%), that is clinically known to impact wound healing ability
Show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration

Show all 9Show fewer

Have, or under treatment for, any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
Show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
Are not willing to undergo further surgery for revision, if medically required

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Washington D.C., District of Columbia

Other trials in United States

About this study

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.

Conditions: Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
Being tested: Natrelle(TM) Silicone-Filled Breast Implants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Natrelle(TM) Silicone-Filled Breast ImplantsDevice
Breast implant surgery

Study groups in NCT00689871
Study group	Role	What they receive
1	Experimental	Primary augmentation Receives: Device: Natrelle(TM) Silicone-Filled Breast Implants
2	Experimental	Primary reconstruction Receives: Device: Natrelle(TM) Silicone-Filled Breast Implants
3	Experimental	Revision-augmentation Receives: Device: Natrelle(TM) Silicone-Filled Breast Implants
4	Experimental	Revision-reconstruction Receives: Device: Natrelle(TM) Silicone-Filled Breast Implants

What is being measured

The primary outcome is the main question the study is designed to answer.

Local Complications
By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts
Measured: 10 years

Secondary outcomes (1)

Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 1999Aug 2011

First posted4 Jun 2008 (estimated)
Study startJan 1999
Primary completionDec 2010
Study completionAug 2011

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.
Publications (6)Papers the sponsor has linked to this study.
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
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 715 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00689871
Sponsor's protocol ID: 020056
Status last verified: Jan 2014
First submitted: 2 Jun 2008
Last updated: 13 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):8S-16S. doi: 10.1097/01.prs.0000286580.93214.df.
PubMed 18090808
Gladfelter J, Murphy D. Breast augmentation motivations and satisfaction: a prospective study of more than 3,000 silicone implantations. Plast Surg Nurs. 2008 Oct-Dec;28(4):170-4; quiz 175-6. doi: 10.1097/PSN.0b013e31818ea7e0.
PubMed 19092580
Murphy DK, Beckstrand M, Sarwer DB. A prospective, multi-center study of psychosocial outcomes after augmentation with natrelle silicone-filled breast implants. Ann Plast Surg. 2009 Feb;62(2):118-21. doi: 10.1097/SAP.0b013e31817f01f8.
PubMed 19158517
Largent JA, Reisman NR, Kaplan HM, Oefelein MG, Jewell ML. Clinical trial outcomes of high- and extra high-profile breast implants. Aesthet Surg J. 2013 May;33(4):529-39. doi: 10.1177/1090820X13484035. Epub 2013 Apr 4.
PubMed 23559355
Namnoum JD, Largent J, Kaplan HM, Oefelein MG, Brown MH. Primary breast augmentation clinical trial outcomes stratified by surgical incision, anatomical placement and implant device type. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):1165-72. doi: 10.1016/j.bjps.2013.04.046. Epub 2013 May 9.
PubMed 23664574
Spear SL, Murphy DK; Allergan Silicone Breast Implant U.S. Core Clinical Study Group. Natrelle round silicone breast implants: Core Study results at 10 years. Plast Reconstr Surg. 2014 Jun;133(6):1354-1361. doi: 10.1097/PRS.0000000000000021.
PubMed 24867717

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Augmentation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
ClinicalTrials.gov ID: NCT00689871
Acronym / sponsor ID: 020056
Conditions: Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
Study type: Interventional
Recruitment status: Completed
Enrolment: 715 participants (actual)
Lead sponsor: Allergan MedicalIndustry (pharma, biotech, devices)
Study start: Jan 1999
Primary completion: Dec 2010 (actual)
Study completion: Aug 2011 (actual)
First posted: 4 Jun 2008 (estimated)
Results: Posted 23 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.

Study design

Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Device: Natrelle(TM) Silicone-Filled Breast ImplantsPrimary augmentation
2	Experimental	Device: Natrelle(TM) Silicone-Filled Breast ImplantsPrimary reconstruction
3	Experimental	Device: Natrelle(TM) Silicone-Filled Breast ImplantsRevision-augmentation
4	Experimental	Device: Natrelle(TM) Silicone-Filled Breast ImplantsRevision-reconstruction

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Female, age 18 years or older
Seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia, asymmetry, ptosis, or aplasia
Seeking primary breast reconstruction
Seeking breast revision-augmentation
Seeking breast revision-reconstruction

Key exclusion criteria (9 listed)

Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
Existing carcinoma of the breast, without mastectomy
Abscess or infection in the body at the time of enrollment
Pregnant or nursing
Have any disease, including uncontrolled diabetes (e.g., HbAIc > 8%), that is clinically known to impact wound healing ability

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
Natrelle(TM) Silicone-Filled Breast ImplantsBreast implant surgery	Device	1, 2, 3, 4

Primary outcome

Local Complications
Time frame: 10 years
By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts

1 secondary outcome

Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Time frame: 10 years

Results and safety

Results posted to the registry on 23 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Augmentation	455	280
Primary Reconstruction	98	46
Revision-augmentation	147	74
Revision-reconstruction	15	8

Primary outcome: Local Complications

Time frame: 10 years. Number (95% Confidence Interval). Unit: percentage by patient

Measure	Primary Augmentation n = 455	Primary Reconstruction n = 98	Revision-augmentation n = 147	Revision-reconstruction n = 15
Capsular Contracture	18.9 (15.4 to 23.1)	24.6 (16.2 to 36.2)	28.7 (21.3 to 37.9)	6.7 (0.2 to 31.9)
Breast Pain	11.5 (8.7 to 15.0)	6.8 (2.8 to 16.1)	11.7 (7.1 to 18.8)	0 (0 to 0)
Swelling	9.2 (6.8 to 12.4)	7.1 (3.5 to 14.4)	8.2 (4.6 to 14.5)	0 (0 to 0)
Implant Malposition	6.9 (4.8 to 9.7)	2.3 (0.6 to 8.9)	6.0 (3.1 to 11.7)	13.3 (1.7 to 40.5)
Nipple Complications	6.3 (4.3 to 9.1)	3.3 (1.1 to 9.8)	1.4 (0.3 to 5.4)	0 (0 to 0)
Hypertrophic/Other Abnormal Scarring	4.2 (2.6 to 6.5)	5.5 (2.3 to 12.7)	6.6 (3.5 to 12.3)	0 (0 to 0)
Asymmetry	3.3 (2.0 to 5.6)	23.2 (15.4 to 33.9)	6.5 (3.2 to 12.8)	6.7 (0.2 to 31.9)
Wrinkling	1.8 (0.8 to 3.7)	10.2 (5.2 to 19.6)	5.4 (2.6 to 11.0)	0 (0 to 0)

Population analysed: all enrolled patients

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Augmentation	0 of 455 (0%)	0 of 455 (0%)	Not reported
Primary Reconstruction	0 of 98 (0%)	0 of 98 (0%)	Not reported
Revision-augmentation	0 of 147 (0%)	0 of 147 (0%)	Not reported
Revision-reconstruction	0 of 15 (0%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): The Revision-reconstruction arm only had 15 patients enrolled, which makes the data for that arm difficult to interpret.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 18090808Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):8S-16S. doi: 10.1097/01.prs.0000286580.93214.df.
Results publication: PubMed 19092580Gladfelter J, Murphy D. Breast augmentation motivations and satisfaction: a prospective study of more than 3,000 silicone implantations. Plast Surg Nurs. 2008 Oct-Dec;28(4):170-4; quiz 175-6. doi: 10.1097/PSN.0b013e31818ea7e0.
Results publication: PubMed 19158517Murphy DK, Beckstrand M, Sarwer DB. A prospective, multi-center study of psychosocial outcomes after augmentation with natrelle silicone-filled breast implants. Ann Plast Surg. 2009 Feb;62(2):118-21. doi: 10.1097/SAP.0b013e31817f01f8.
Results publication: PubMed 23559355Largent JA, Reisman NR, Kaplan HM, Oefelein MG, Jewell ML. Clinical trial outcomes of high- and extra high-profile breast implants. Aesthet Surg J. 2013 May;33(4):529-39. doi: 10.1177/1090820X13484035. Epub 2013 Apr 4.
Results publication: PubMed 23664574Namnoum JD, Largent J, Kaplan HM, Oefelein MG, Brown MH. Primary breast augmentation clinical trial outcomes stratified by surgical incision, anatomical placement and implant device type. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):1165-72. doi: 10.1016/j.bjps.2013.04.046. Epub 2013 May 9.
Derived from this study: PubMed 24867717Spear SL, Murphy DK; Allergan Silicone Breast Implant U.S. Core Clinical Study Group. Natrelle round silicone breast implants: Core Study results at 10 years. Plast Reconstr Surg. 2014 Jun;133(6):1354-1361. doi: 10.1097/PRS.0000000000000021.

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Memory Gel and Shape Combined Cohort
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Natrelle(TM) Silicone-Filled Breast Implants in people with Breast Augmentation and Breast Reconstruction, run by Allergan Medical at 1 site 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 9 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: finished, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 23 Jan 2012). 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?

Local Complications (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00689871, which also lists 6 linked publications.

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 13 Oct 2014.