AugmentationPhase 3NCT00981266
Spectra Breast Implant Study
A Phase 3 study testing Mentor Spectra/Becker 80 Breast Implant in people with Augmentation and Augmentation Revision, run by Mentor Worldwide, LLC at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision breast augmentation. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Augmentation, Augmentation Revision, General Breast Enlargement
- What is being tested?
- Mentor Spectra/Becker 80 Breast Implant
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Oct 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is genetic female and is at least 22-years-old
- A candidate for primary breast augmentation (general breast enlargement, post-lactational involution, asymmetry) or augmentation revision (previous augmentation with silicone-filled or saline-filled implants)
- Signs the Informed Consent
- Agrees to return device to Mentor if explant necessary
- Agrees to comply with follow-up procedures, including returning for all follow-up visits
- Patient is a US citizen with a Social Security Number
Who cannot join
- Subject is pregnant
- Has nursed a child within three months of study enrollment
- Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants).
- Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
- Currently has a condition that could compromise or complicate wound healing
- Has diagnosis of active cancer of any type
Show all 16Show fewer
- Infection or abscess anywhere in the body
- Demonstrates tissue characteristics which are clinically incompatible with implant placement (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity)
- Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physician(s), may constitute an unwarranted surgical risk
- Anatomic or physiologic abnormality which could lead to significant postoperative adverse events
- Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
- Premalignant breast disease without a subcutaneous mastectomy
- Untreated or inappropriately treated breast malignancy, without mastectomy
- Are HIV positive
- Work for Mentor or the study doctor or are directly related to anyone that works for Mentor or the study doctor
- Implanted metal or metal devices, history of claustrophobia or other condition that would make a MRI scan prohibitive
Trial locations and contacts
1 site in 1 country.
United States1 site
Mentor Worldwide LLC
Santa Barbara, California, 93111
About this study
Official title: Study of the Safety and Effectiveness of the Mentor Spectra/Becker 80 Adjustable Breast Implant in Subjects Who Are Undergoing Primary Augmentation or Augmentation Revision
The purpose of this study is to demonstrate safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision breast augmentation. Safety information on the rate of complications, such as infection, will be collected and used to help determine device safety. These implants are investigational devices.
Approximately 450 patients at sites across the United States will be enrolled in this research study by up to 30 sites. These patients will be implanted with Spectra/Becker 80 implant and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.
Read the detailed description
Silicone gel-filled breast implants were introduced in the early sixties and were in wide-scale distribution by the time the Medical Device Amendments to the Food Drug and Cosmetic Act was passed in 1976. In 1983, gel-filled breast implants were designated as Class III devices requiring premarket approval. In May 1990, the Food and Drug Administration (FDA) published a proposed request (515(b)) for Pre-market Approval Applications (PMA) and in April 1991 published the final request. This final publication put manufacturers of gel-filled breast implants on notice that for continued marketing of gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.
A Pre-Market Approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November 1991, the committee recommended the submission of additional information to establish the safety and effectiveness of gel-filled breast implants.
In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of gel-filled breast implants to allow the advisory panel time to assess additional information. In April 1992, the moratorium was lifted but only for reconstruction and revision subjects. Every subject implanted had to be part of an Adjunct Study, in addition to being offered participation in a registry of gel-filled breast implant subjects. The Adjunct Study devices included the round MemoryGel, Becker Expander/Prosthesis and the Lumera implants. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in an Investigational Device Exemption (IDE) clinical trial.
A PMA for Mentor's MemoryGel™ Silicone Gel-Filled breast implants (which did not include the Becker Expander/Breast Implants) was subsequently filed with FDA in December 2003, and approved in November 2006 (P030053). As a condition of approval of P030053, new enrollment in Mentor's Adjunct Study has ceased, and women no longer have access to the Becker Expander/Breast Implants or any Adjustable Gel-Filled implants. The Spectra/Becker 80 Adjustable Breast Implants were not included in the Adjunct Study.
This study is designed to study the safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants for primary breast augmentation or augmentation revision.
- Conditions
- Augmentation, Augmentation Revision, General Breast Enlargement, Post-lactational Involution, Asymmetry
- Being tested
- Mentor Spectra/Becker 80 Breast Implant
- Keywords
- Augmentation, Augmentation Revision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentor Spectra/Becker 80 Breast ImplantDevice
Also called Breast Implant, Double Lumen Breast-Implant, Becker 80 Implant, Spectra Implant
The Mentor Smooth Spectra/Becker 80 Adjustable Breast Implant has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over a period of time via the fill tube by injecting saline through the injection dome. Once filled to the desired volume, the fill tube and injection dome are removed, and the prosthesis remains in position as a breast implant. Its purpose is to provide volume flexibility and projection adjustability.
| Study group | Role | What they receive |
|---|---|---|
| Augmentation | Other | The study population will consist of women aged 22 or over who are undergoing primary breast augmentation.
The Augmentation cohort will include candidates for general breast enlargement, post-lactational involution and/or asymmetry. Receives: Device: Mentor Spectra/Becker 80 Breast Implant |
| Augmentation Revision | Other | The study population will consist of women aged 22 or over who are undergoing augmentation revision.
The Augmentation Revision cohort will include candidates with previous augmentation with silicone-filled or saline-filled implants. Receives: Device: Mentor Spectra/Becker 80 Breast Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be determined by the incidence, severity, method of resolution, and duration for all adverse events on a per implant and per subject basis.
Measured: 10 years
Effectiveness will be determined by changes in chest circumference and bra and cup size.
Measured: 10 Years
Secondary outcomes (1)
Effectiveness will also be determined by changes in validated Quality of Life instrument ratios.
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startJun 2013
- Primary completionJan 2024 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: Business decision. Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mentor Worldwide, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kaveh Alizadeh, M.D., Principal investigator, Garden City, NYJoseph Bauer, M.D., Principal investigator, Alpharetta, GASteven P. Bloch, M.D., Principal investigator, Highland Park, ILWilliam R. Burden, M.D., Principal investigator, Destin, FLDavid Caplin, M.D., Principal investigator, St. Louis, MOMichael Cohen, M.D., Principal investigator, Towson, MDSteven Gitt, M.D., Principal investigator, Phoenix, AZMike E. Gonce, M.D., Principal investigator, Oklahoma City, OK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981266
- Sponsor's protocol ID
- A101-0501-10
- Status last verified
- Feb 2013
- First submitted
- 28 Jul 2009
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bondurant, S., V.L. Ernster and R. Herdman, Eds. 2000. Safety of silicone breast implants. Committee on the Safety of Silicone Breast Implants, Division of Health Promotion and Disease Prevention, Institute of Medicine. Washington, D.C.: National Academy
Holmich LR, Vejborg IM, Conrad C, Sletting S, Hoier-Madsen M, Fryzek JP, McLaughlin JK, Kjoller K, Wiik A, Friis S. Untreated silicone breast implant rupture. Plast Reconstr Surg. 2004 Jul;114(1):204-14; discussion 215-6. doi: 10.1097/01.prs.0000128821.87939.b5.
PubMed 15220594Holmich LR, Kjoller K, Vejborg I, Conrad C, Sletting S, McLaughlin JK, Fryzek J, Breiting V, Jorgensen A, Olsen JH. Prevalence of silicone breast implant rupture among Danish women. Plast Reconstr Surg. 2001 Sep 15;108(4):848-58; discussion 859-63. doi: 10.1097/00006534-200109150-00006.
PubMed 11547138Katzin WE, Centeno JA, Feng LJ, Kiley M, Mullick FG. Pathology of lymph nodes from patients with breast implants: a histologic and spectroscopic evaluation. Am J Surg Pathol. 2005 Apr;29(4):506-11. doi: 10.1097/01.pas.0000155145.60670.e4.
PubMed 15767806Berner I, Gaubitz M, Jackisch C, Pfleiderer B. Comparative examination of complaints of patients with breast-cancer with and without silicone implants. Eur J Obstet Gynecol Reprod Biol. 2002 Apr 10;102(1):61-6. doi: 10.1016/s0301-2115(01)00561-9.
PubMed 12039092Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol. 2001 May;28(5):996-1003.
PubMed 11361228Holmich LR, Kjoller K, Fryzek JP, Hoier-Madsen M, Vejborg I, Conrad C, Sletting S, McLaughlin JK, Breiting V, Friis S. Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants. Plast Reconstr Surg. 2003 Feb;111(2):723-32; discussion 733-4. doi: 10.1097/01.PRS.0000041442.53735.F8.
PubMed 12560693Wolfe F, Anderson J. Silicone filled breast implants and the risk of fibromyalgia and rheumatoid arthritis. J Rheumatol. 1999 Sep;26(9):2025-8.
PubMed 10493686Brinton LA, Buckley LM, Dvorkina O, Lubin JH, Colton T, Murray MC, Hoover R. Risk of connective tissue disorders among breast implant patients. Am J Epidemiol. 2004 Oct 1;160(7):619-27. doi: 10.1093/aje/kwh272.
PubMed 15383405Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000 Mar 16;342(11):781-90. doi: 10.1056/NEJM200003163421105.
PubMed 10717013Lipworth L, Tarone RE, McLaughlin JK. Silicone breast implants and connective tissue disease: an updated review of the epidemiologic evidence. Ann Plast Surg. 2004 Jun;52(6):598-601. doi: 10.1097/01.sap.0000128087.51384.f9.
PubMed 15166995Tugwell P, Wells G, Peterson J, Welch V, Page J, Davison C, McGowan J, Ramroth D, Shea B. Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel. Arthritis Rheum. 2001 Nov;44(11):2477-84. doi: 10.1002/1529-0131(200111)44:113.0.co;2-q.
PubMed 11710703Williams HJ, Weisman MH, Berry CC. Breast implants in patients with differentiated and undifferentiated connective tissue disease. Arthritis Rheum. 1997 Mar;40(3):437-40. doi: 10.1002/art.1780400308.
PubMed 9082930Breiting VB, Holmich LR, Brandt B, Fryzek JP, Wolthers MS, Kjoller K, McLaughlin JK, Wiik A, Friis S. Long-term health status of Danish women with silicone breast implants. Plast Reconstr Surg. 2004 Jul;114(1):217-26; discussion 227-8. doi: 10.1097/01.prs.0000128823.77637.8a.
PubMed 15220596Fryzek JP, Signorello LB, Hakelius L, Feltelius N, Ringberg A, Blot WJ, McLaughlin JK, Nyren O. Self-reported symptoms among women after cosmetic breast implant and breast reduction surgery. Plast Reconstr Surg. 2001 Jan;107(1):206-13. doi: 10.1097/00006534-200101000-00034.
PubMed 11176625
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Effectiveness of the Mentor Spectra/Becker 80 Adjustable Breast Implant in Subjects Who Are Undergoing Primary Augmentation or Augmentation Revision
- ClinicalTrials.gov ID
- NCT00981266
- Acronym / sponsor ID
- A101-0501-10
- Conditions
- Augmentation, Augmentation Revision, General Breast Enlargement, Post-lactational Involution, Asymmetry
- Keywords
- Augmentation, Augmentation Revision
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision. Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision breast augmentation. Safety information on the rate of complications, such as infection, will be collected and used to help determine device safety. These implants are investigational devices.
Approximately 450 patients at sites across the United States will be enrolled in this research study by up to 30 sites. These patients will be implanted with Spectra/Becker 80 implant and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.
Detailed description
Silicone gel-filled breast implants were introduced in the early sixties and were in wide-scale distribution by the time the Medical Device Amendments to the Food Drug and Cosmetic Act was passed in 1976. In 1983, gel-filled breast implants were designated as Class III devices requiring premarket approval. In May 1990, the Food and Drug Administration (FDA) published a proposed request (515(b)) for Pre-market Approval Applications (PMA) and in April 1991 published the final request. This final publication put manufacturers of gel-filled breast implants on notice that for continued marketing of gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.
A Pre-Market Approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November 1991, the committee recommended the submission of additional information to establish the safety and effectiveness of gel-filled breast implants.
In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of gel-filled breast implants to allow the advisory panel time to assess additional information. In April 1992, the moratorium was lifted but only for reconstruction and revision subjects. Every subject implanted had to be part of an Adjunct Study, in addition to being offered participation in a registry of gel-filled breast implant subjects. The Adjunct Study devices included the round MemoryGel, Becker Expander/Prosthesis and the Lumera implants. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in an Investigational Device Exemption (IDE) clinical trial.
A PMA for Mentor's MemoryGel™ Silicone Gel-Filled breast implants (which did not include the Becker Expander/Breast Implants) was subsequently filed with FDA in December 2003, and approved in November 2006 (P030053). As a condition of approval of P030053, new enrollment in Mentor's Adjunct Study has ceased, and women no longer have access to the Becker Expander/Breast Implants or any Adjustable Gel-Filled implants. The Spectra/Becker 80 Adjustable Breast Implants were not included in the Adjunct Study.
This study is designed to study the safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants for primary breast augmentation or augmentation revision.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmentation | Other | Device: Mentor Spectra/Becker 80 Breast ImplantThe study population will consist of women aged 22 or over who are undergoing primary breast augmentation. The Augmentation cohort will include candidates for general breast enlargement, post-lactational involution and/or asymmetry. |
| Augmentation Revision | Other | Device: Mentor Spectra/Becker 80 Breast ImplantThe study population will consist of women aged 22 or over who are undergoing augmentation revision. The Augmentation Revision cohort will include candidates with previous augmentation with silicone-filled or saline-filled implants. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is genetic female and is at least 22-years-old
- A candidate for primary breast augmentation (general breast enlargement, post-lactational involution, asymmetry) or augmentation revision (previous augmentation with silicone-filled or saline-filled implants)
- Signs the Informed Consent
- Agrees to return device to Mentor if explant necessary
- Agrees to comply with follow-up procedures, including returning for all follow-up visits
Key exclusion criteria (16 listed)
- Subject is pregnant
- Has nursed a child within three months of study enrollment
- Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants).
- Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
- Currently has a condition that could compromise or complicate wound healing
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 |
|---|---|---|
| Mentor Spectra/Becker 80 Breast ImplantAlso: Breast Implant, Double Lumen Breast-Implant, Becker 80 Implant, Spectra ImplantThe Mentor Smooth Spectra/Becker 80 Adjustable Breast Implant has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over a period of time via the fill tube by injecting saline through the injection dome. Once filled to the desired volume, the fill tube and injection dome are removed, and the prosthesis remains in position as a breast implant. Its purpose is to provide volume flexibility and projection adjustability. | Device | Augmentation, Augmentation Revision |
Primary outcome
Safety will be determined by the incidence, severity, method of resolution, and duration for all adverse events on a per implant and per subject basis.
Time frame: 10 years
Effectiveness will be determined by changes in chest circumference and bra and cup size.
Time frame: 10 Years
1 secondary outcome
Effectiveness will also be determined by changes in validated Quality of Life instrument ratios.
Time frame: 10 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
- BackgroundBondurant, S., V.L. Ernster and R. Herdman, Eds. 2000. Safety of silicone breast implants. Committee on the Safety of Silicone Breast Implants, Division of Health Promotion and Disease Prevention, Institute of Medicine. Washington, D.C.: National Academy
- Background: PubMed 15220594Holmich LR, Vejborg IM, Conrad C, Sletting S, Hoier-Madsen M, Fryzek JP, McLaughlin JK, Kjoller K, Wiik A, Friis S. Untreated silicone breast implant rupture. Plast Reconstr Surg. 2004 Jul;114(1):204-14; discussion 215-6. doi: 10.1097/01.prs.0000128821.87939.b5.
- Background: PubMed 11547138Holmich LR, Kjoller K, Vejborg I, Conrad C, Sletting S, McLaughlin JK, Fryzek J, Breiting V, Jorgensen A, Olsen JH. Prevalence of silicone breast implant rupture among Danish women. Plast Reconstr Surg. 2001 Sep 15;108(4):848-58; discussion 859-63. doi: 10.1097/00006534-200109150-00006.
- Background: PubMed 15767806Katzin WE, Centeno JA, Feng LJ, Kiley M, Mullick FG. Pathology of lymph nodes from patients with breast implants: a histologic and spectroscopic evaluation. Am J Surg Pathol. 2005 Apr;29(4):506-11. doi: 10.1097/01.pas.0000155145.60670.e4.
- Background: PubMed 12039092Berner I, Gaubitz M, Jackisch C, Pfleiderer B. Comparative examination of complaints of patients with breast-cancer with and without silicone implants. Eur J Obstet Gynecol Reprod Biol. 2002 Apr 10;102(1):61-6. doi: 10.1016/s0301-2115(01)00561-9.
- Background: PubMed 11361228Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol. 2001 May;28(5):996-1003.
- Background: PubMed 12560693Holmich LR, Kjoller K, Fryzek JP, Hoier-Madsen M, Vejborg I, Conrad C, Sletting S, McLaughlin JK, Breiting V, Friis S. Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants. Plast Reconstr Surg. 2003 Feb;111(2):723-32; discussion 733-4. doi: 10.1097/01.PRS.0000041442.53735.F8.
- Background: PubMed 10493686Wolfe F, Anderson J. Silicone filled breast implants and the risk of fibromyalgia and rheumatoid arthritis. J Rheumatol. 1999 Sep;26(9):2025-8.
- Background: PubMed 15383405Brinton LA, Buckley LM, Dvorkina O, Lubin JH, Colton T, Murray MC, Hoover R. Risk of connective tissue disorders among breast implant patients. Am J Epidemiol. 2004 Oct 1;160(7):619-27. doi: 10.1093/aje/kwh272.
- Background: PubMed 10717013Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000 Mar 16;342(11):781-90. doi: 10.1056/NEJM200003163421105.
- Background: PubMed 15166995Lipworth L, Tarone RE, McLaughlin JK. Silicone breast implants and connective tissue disease: an updated review of the epidemiologic evidence. Ann Plast Surg. 2004 Jun;52(6):598-601. doi: 10.1097/01.sap.0000128087.51384.f9.
- Background: PubMed 11710703Tugwell P, Wells G, Peterson J, Welch V, Page J, Davison C, McGowan J, Ramroth D, Shea B. Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel. Arthritis Rheum. 2001 Nov;44(11):2477-84. doi: 10.1002/1529-0131(200111)44:113.0.co;2-q.
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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.
Kaveh Alizadeh, M.D. principal investigator
Garden City, NY
Joseph Bauer, M.D. principal investigator
Alpharetta, GA
Steven P. Bloch, M.D. principal investigator
Highland Park, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mentor Spectra/Becker 80 Breast Implant in people with Augmentation and Augmentation Revision, run by Mentor Worldwide, LLC 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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 1 Mar 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety will be determined by the incidence, severity, method of resolution, and duration for all adverse events on a per implant and per subject basis. (time frame: 10 years). 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?
On the ClinicalTrials.gov record for NCT00981266, which also lists 39 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 1 Mar 2013.