Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation
Phase: NA
Conditions: Breast Augmentation, Breast Reconstruction, Breast Revision
Sponsor: Tiger Biosciences, LLC.

SILIMED GEL-FILLED MAMMARY IMPLANT  
CLINICAL STUDY PROTOCOL: 
 
Current Study Sponsor: 
Sientra, Inc. 
6500 Hollister Avenue, Suite 120 
Goleta, CA  93117 
(805) 562-3500 
Study Product: 
Silimed Gel-Filled Mammary Implant 
CONFIDENTIAL 
This document is confidential and the property of the Sientra, Inc.  No part of it may be 
transmitted, reproduced, published, or used by other persons without prior written 
authorization from the study sponsor. 

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LIST OF ABBREVIATIONS 
AE
Adverse Event 
CA
Continued Access 
CORE
Core Clinical Investigation 
CTD
Connective Tissue Disease 
FDA
U.S. Food and Drug Administration 
GCP
Good Clinical Practice 
IRB
Institutional Review Board 
MRI
Magnetic Resonance Imaging 
PMA
Premarket Approval 
QOL
Quality-of-Life 
SEM
Standard of Measurement 
UADE 
Unanticipated Adverse Device Effect 

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1.
INTRODUCTION
This document is a protocol for a human research study.  This prospective clinical study is 
designed to document the safety and effectiveness of the Silimed Gel-Filled Mammary 
Implant (also referred to in this document as the “Implant” or “Implants”) as indicated for 
primary augmentation, primary reconstruction, and/or revision of the female breast.  
 
 
1.1. Silimed Gel-Filled Mammary Implant 
 
.  The shell is filled with a proprietary silicone gel.  The implants are either 
round or contoured in shape and are available in a range of diameters, profiles (projections), 
and sizes.  The Implants have either smooth or textured shell surfaces. 
1.2. Study Overview 
Surgical implantation of the Implant is indicated for primary augmentation, primary 
reconstruction, and/or revision of the female breast.  Approximately 1,000 subjects will 
participate in the Core Clinical Investigation (“CORE Study”).  Subjects will be recruited 
through numerous investigational sites by Investigators throughout the United States.  
 

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2.
STUDY OBJECTIVES 
The purpose of the CORE Study is to demonstrate the safety and effectiveness of the 
Implants as indicated for primary augmentation, primary reconstruction, and/or revision of 
the female breast. 
3.
STUDY DESIGN 
3.1. Overview of the CORE Clinical Investigation 
The CORE study is an open-label, multicenter, prospective clinical investigation designed to 
evaluate the safety and effectiveness of the Silimed Gel-Filled Mammary Implants.  These 
Implants are indicated for unilateral or bilateral primary augmentation, primary 
reconstruction, and/or revision of the female breast.  This study will enroll approximately 
1,000 subjects at 50 primary sites, with approximately 40 subjects per site.  
 
 
  An agreement with each Investigator will specifically outline the number and type 
of implant subjects that she/he will enroll.  The differences in enrollment mix per 
Investigator will be based upon the last annual surgical history of the Investigator (e.g., 
certain sites may specialize in augmentation, reconstruction, or revision).  Subjects will be 
followed for a minimum of 10 years following placement of mammary implant(s). 

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3.2. Control Group and Randomization Considerations in the CORE Study 
In this study, subjects act as their own controls.  There are practical implications and 
limitations to randomization in a study involving a medical device that creates an aesthetic 
result.  If randomization is used to select the style of the implant or manufacturer of the 
implant for each subject, instead of allowing the Investigator and subject to determine the 
appropriate choice, a less than optimal outcome may result.  Randomization to assign a 
particular implant to a subject may have a significant negative effect on the outcome of the 
procedure if the shape/style of the implant is not appropriate for a particular body structure or 
the subject's preference.  
The data obtained at baseline on each subject will be used as the control data.  Information 
from each subject will provide control (baseline) data for physical status, cancer history and 
status, rheumatologic history and status, medical history and status, and connective tissue 
history and status.  Any changes noted by the physician or reported by the subject in any of 
these areas will be recorded. 

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3.3. Study Design and Outcome Measures 
All subjects will be screened for eligibility and informed consent will be obtained prior to 
enrollment in the study.  Each subject will be evaluated preoperatively to document baseline 
status.  All subjects will complete the QOL questionnaire.  Photographs will be taken during 
the preoperative visit with additional photographs taken at the 1-year postoperative follow-up 
visit. 
Details of each surgical procedure will be recorded immediately, postoperatively.  Subjects 
are considered study participants once their Implant(s) has/have been placed.  Following 
placement of the Implant, subjects will present for follow-up office visits at 6-10 weeks, 12 
months, 24 months, and annually for the remaining 8 years.  
 
 
 
  
 
 
 
 
  
All secondary treatments and procedures related to the breast, including explant surgery 
without replacement, will be recorded.  Photographs will also be taken prior to and following 
(6-12 months) any secondary treatment or procedure considered remedial in nature. 
All patients will be directed to see a physician if they believe they have a ruptured implant, 
and these patients will undergo a magnetic resonance imaging (MRI) scan. 
Safety of the Implants will be assessed by examining the incidence, severity, method of 
resolution, and duration for all complications on a per-implant and per-patient basis.  

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3.4. Safety Endpoints 
As stated above, assessment of the safety of the Implants will be based on incidence, 
severity, method of resolution, and duration for all complications on a per-implant and per-
patient basis.  The rate of asymptomatic or “silent” rupture will be assessed via MRI at 
regular intervals in a subset of subjects from the CORE study.  Other potential complications 
of the mammary implant surgery include possible systemic effects (e.g., autoimmune and/or 
rheumatologic effects) and interference with radiological detection of breast cancer in 
remaining breast tissues.  Safety assessments are described in more detail in the sections that 
follow. 

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3.5. Effectiveness Endpoints 
This assessment will incorporate the effects of the following: the initial surgical procedure, 
adjunctive surgical and medical procedures, complications, and whether the expected 
benefits of the procedure and the implants have been met.  Subject satisfaction data will be 

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acquired to assess the effects of device explantation, regardless of whether or not the device 
is replaced. 
4.
SUBJECT SELECTION AND WITHDRAWAL 
4.1. Inclusion Criteria 
Subjects are admitted into the study only if all of the following eligibility is true: 
1. Female 
2. Age limitation specific to the indication: 
Primary Augmentation:  Must be 18 years or older 
Primary Reconstruction:  No age limit 
Revision:  If original surgery was primary reconstruction, then no age limit.  If 
original surgery was primary augmentation, then must be 18 years or older. 
3. Adequate tissue available to cover implant(s) 
4. Willingness to follow study requirements (informed consent form, follow-up visits) 
5. Candidate for primary augmentation, primary reconstruction, or revision 
 

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4.2. Exclusion Criteria 
Subjects are not eligible if any of the following criteria exist: 
1. Advanced fibrocystic disease, considered to be pre-malignant without mastectomy 
2. Inadequate or unsuitable tissue 
 
 
 
3. Active infection in the body at the time of surgery 
4. Pregnant or lactating 
5. Medical condition such as obesity, diabetes, autoimmune disease, chronic lung or 
severe cardiovascular disease that might result in unduly high surgical risk and/or 
significant postoperative complications, in the judgment of the Investigator 
6. Use of drugs, including any drug that would interfere with blood clotting, that might 
result in high risk and/or significant postoperative complications 
7. Demonstrated psychological characteristics that are unrealistic or unreasonable given 
the risks involved with the surgical procedure 
8. Determination by physical examination that the subject does have any connective 
tissue/autoimmune disorder, 
 
  

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5.
STUDY PROCEDURES 
5.1. Preoperative/Initial Visit 
1. Subject eligibility will be determined.  All subjects considering study participation 
will be entered into the study logbook.  If a subject does not wish to participate in the 
clinical study, the reason is noted on the enrollment log.  Only eligible subjects who 
agree to participate will be issued log numbers and will complete the remaining steps. 
2. Demographic information will be collected. 
6. Subject Informed Consent will be obtained.  
 
 
 
7. A physical exam will be performed.  Other diagnostic procedures, such as chest x-ray 
or electrocardiogram may be performed at the discretion of the Investigator. 
8. Medical history, including reproductive history, lactation history, breast screening 
history, and history of all medications taken within the last 3 months will be recorded. 

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9. For subjects in the CORE Study 
, rheumatologic information will be obtained via 
the Rheumatology Screening Questionnaire as a baseline measurement prior to 
implant surgery. 
10. Detailed breast cancer data will be collected prior to, or at the same time as 
enrollment.  Investigators will have up to 6 months after subject enrollment to provide 
specific information. 
11. Preoperative surgical information will be recorded, including the specific indications 
(e.g., reconstruction following mastectomy) for the procedure, as well as the proposed 
procedure (e.g., mastectomy, implantation of a tissue expander, insertion of a 
mammary implant). 
12. Baseline mammography will be performed, as appropriate.  Since some of the 
subjects participating in this study have a history of breast disease or a concern 
regarding breast disease (prophylactic mastectomy subjects), and will have or had 
surgery for this condition, they may or may not be a candidate for mammography.  
The Investigator must discuss this important issue with the subject.  Subjects with one 
or more remaining breasts, or remaining breast tissue, should have a baseline 
mammogram prior to surgery.  
 
 
 
 
13. Subjects will be asked to complete a confidential questionnaire 
 
14. Preoperative photos of the breast/chest area will be taken prior to surgery. 

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6.
STATISTICAL PLAN 
6.1. Sample Size, and Subject Drop-Out Considerations 
6.1.1.
Sample Size and Power Considerations 
A sample size of 1,000 subjects for the CORE study was initially chosen to ensure accurate 
measures of both the safety and effectiveness of the device.  
 

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To characterize the safety and effectiveness of the device, the prevalence and cumulative 
incidence of complications will be examined at each visit for each separate subject cohort 
and for the total population.  
 

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6.1.2.
Subject Drop-Out and Potential Bias 
Subjects may discontinue their participation in this study at any time.  While it is not possible 
to predict the reason for dropouts or loss to follow-up, the Sponsor plans to seek final data 
from subjects who no longer wish to participate in this clinical trial.  
 
6.1.3.
General Statistical Methods: Hierarchical Models 
The data will be analyzed using hierarchical models.  Hierarchical models account for 
correlation in the data (e.g., within sites) by explicitly modeling each "level" of variability. 
Hierarchical models, also called random effects, mixed, or multilevel models, are well 
established for continuous measures (Rao 1965, Laird and Ware 1982), binary responses (e.g. 
Stiratelli et al. 1984, Zeger and Karim 1991), and count data (Lee 1997).  Hierarchical 
models provide an estimate of the population average effect by combining information across 
individuals, while taking into account correlation within sites.  

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6.1.4.
Analysis of Complications 
Incidence rates and time course evaluations for complications will be presented using 
survival analysis.  These analyses will be done on both a per-subject and a per-device basis, 
for each subject cohort and for the total population.  
 
6.1.5.
Analysis of Effectiveness Measures 
The change in QOL measures will be estimated using mixed models, adjusting for the 
correlation within subjects over time.  QOL variables will be transformed before analysis, if 
necessary, to meet the normality and homogeneity-of-variance assumptions of the mixed 
model.

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8.4. Administrative Plan to Minimize Risks 
 
Sientra, 
as the current Sponsor has contracted with an independent CRO to continue monitoring of 
the Study. 
 
  Risks to the subject population will be 
minimized by ensuring that the clinical study will be conducted according to IDE regulations.  
At study initiation Silimed’s monitoring plan specifically outlined the review of Investigator 
credentials, followed by a review by the IRB.  Investigators were to have signed an 
Investigator’s Agreement that requires strict adherence to the protocol. 
Silimed had a monitoring policy in place that was to ensure no subject is admitted to the 
study until the investigative site has received IRB approval.  No implant surgery can take 
place until the subject has signed the informed consent. 

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The site monitors were provided a site monitoring manual that specified periodic audits of 
patient screening accountability records and source documentation.  The case report forms 
were to be reviewed by the central monitor to ensure protocol compliance. 

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8.6. Benefits of Breast Prosthesis 
There may be quality of life benefits related to breast augmentation and/or reconstruction 
with mammary implants.  The main purpose of these procedures is to restore the appearance 
of a woman’s breast.  It has been reported that breast reconstruction with mammary implants 
has been beneficial in aiding a patient’s recovery from breast cancer and reducing emotional 
stress by helping to return her body to a more natural appearance. 
Each woman has her own sense of how she wishes to look and whether she wishes to 
undergo surgery to restore or augment her breast(s) to achieve this appearance.  A study has 
shown a high degree of satisfaction following breast implant surgery.  The study 
demonstrated that most of these women had a very positive body image, decreased self-
consciousness, and heightened self-confidence; an overwhelming majority said they felt 
better about themselves after surgery; 86% felt the operation was a complete success and 
95% said their expectations were met (Young et al. 1994).  Another study that surveyed 
women after mastectomy for cancer reported they felt more balanced, whole, less depressed 
and glad they had undergone breast reconstruction (Corsten et al. 1992).
Women entering this study may benefit other women by providing safety and efficacy 
information about the gel-filled mammary implants, including health problems associated 
with gel-filled mammary implants. 

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9.
DATA HANDLING AND RECORD KEEPING 
9.1. Confidentiality 
Information from this study will be provided to the Sponsor; it will also be given to the FDA.  
It may be given to governmental agencies in other countries where the Study device may be 
considered for approval.  Medical records and photographs that identify subjects and the 
consent form signed by enrolled subjects will be looked at and/or copied for research or 
regulatory purposes by: 
the Sponsor 
 the Sponsor’s Clinical Research Organization. 
And may also be looked at and/or copied for research or regulatory purposes by: 
the FDA 
other Department of Health and Human Services (DHHS) agencies; 
Government agencies in other countries 
the applicable Institutional Review Board(s) 
Confidentiality will be protected as much as possible throughout this study.  Medical records 
may be accessed by the Sponsor’s research personnel and reviewed as required by the FDA.  
Results of data collected will be reported as statistical information only. 
The subject’s unique identification number will be listed on all clinical study records, 
including clinical study case report forms and QOL questionnaires.  
The possibility exists that clinical records could be obtained by Congress or by a court order. 
Every effort will be taken by the Sponsor to keep this information confidential.  Under 
certain circumstances this could mean public disclosure of subject surgeries and subsequent 
loss of subject confidentiality. 
9.2. Case Report Forms 
CRFs will be completed on all study participants based on the type of visit scheduled.  
 

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10.
STUDY MONITORING 
The Medical Monitor’s responsibilities include review of the investigational plan, review of 
adverse reactions or unanticipated adverse device effects, and interpretation of clinical 
results.  The Medical Monitor is qualified by training and qualifications to perform the duties 
as such. 

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11.
INVESTIGATOR RESPONSIBILITIES AND RECORDS 
Investigators selected by the Sponsor will be either board-certified plastic surgeons, surgeons 
certified in augmentation or reconstruction, or both.  The Investigators must also have 
demonstrated that their facility has the ability to provide the required support personnel to 
meet the study’s objectives. 
11.1.
Investigator’s Responsibilities 
Each Investigator must follow the Investigator Agreement 
 the investigational 
plan, and all conditions of IRB approval.
A signed Investigator Agreement and written 
confirmation of IRB approval must be provided to the Sponsor by the Investigator prior to 
subject enrollment and the start of the study. 
The Investigator shall make known to the subjects the nature, expected duration, and purpose 
of the study, the administration and potential risks of treatment, and available alternative 
therapy.
Subjects will be informed that their medical records will be subject to review by the Sponsor 
and its representatives, the Institutional Review Board(s), and the FDA.  The subjects shall 
be informed that they are free to refuse participation in this clinical investigation, and if they 
participate, that they may withdraw from the study at any time without prejudicing future 
medical care.  Signed Research Subject Information and Consent Forms must be obtained 

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prior to surgery.  The original will be kept by the Investigator and will be reviewed by the 
Sponsor or its CRO.  A copy of the signed informed consent will be given to the subject. 
11.2.
Investigator Records 
Investigators will maintain complete, accurate and current study records, including the 
following material: 
Correspondence with the Sponsor, the FDA, the IRB, and other Investigators 
Subject records, including Informed Consent documents, copies of Case Report Forms 
and any supporting documents (e.g., diagnostic reports) and registry enrollment 
Study protocol with dates and reason for deviations that may affect the scientific quality 
of the study 
Copies of unanticipated adverse device reports 

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11.4.
Protocol Deviations 
Deviations from the protocol that may affect the scientific quality of the study or the rights, 
safety, or welfare of the subjects require prior approval of the Sponsor and the IRB.  If 
deviations are required to protect the subject, the Investigator will notify the Sponsor and the 
Investigator’s IRB within 5 working days that such a deviation has occurred. 
11.5.
Research Subject Study Packet or IRB Replacement Packet 
The Sponsor will provide site specific Research Subject Study Packets to each Investigator to 
give to the subject during their pre-operative screening visit.  This includes, but may not be 
limited to the following information: 
A sample of the Subject Informed Consent (Research Subject Information and 
Consent Form)/Incentive Program Table 
Experimental Subject’s Bill of Rights 

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11.7.
Informed Consent 
Informed consent must be obtained from all subjects to permit their study participation. The 
consent form must be signed by the subject.  
 
 
11.8.
Institutional Review Board (IRB) 
The clinical study of the Implants may not begin at any site until Institutional Review Board 
(IRB) approval is obtained.
Investigators will provide accurate, complete, and current information to their IRB whenever 
necessary. 
Deviations from the protocol that may affect the scientific quality of the study, or the rights, 
safety, or welfare of the subjects require prior approval of the IRB. 
Investigators will report to the Sponsor immediately if, for any reason, their IRB withdraws 
approval to conduct the investigation.  The report will include a complete description of the 
reason approval was withdrawn. 
12.
STUDY FINANCES 
12.1.
Funding Source 
Funding for this research study will be provided by the Sponsor. 

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Sientra, Inc. 
Clinical Study Protocol:  
 
______________________________________________________________________________________________________________________________________________________
August 11, 2008 
CONFIDENTIAL
 
-59-

Silimed Gel-Filled Mammary Implant 
Sientra, Inc. 
Clinical Study Protocol:  
 
______________________________________________________________________________________________________________________________________________________
August 11, 2008 
CONFIDENTIAL
 
-60-

Silimed Gel-Filled Mammary Implant 
Sientra, Inc. 
Clinical Study Protocol:  
 
______________________________________________________________________________________________________________________________________________________
August 11, 2008 
CONFIDENTIAL
 
-61-