Motiva Implants®
You have been asked to volunteer to take part in a 10-year research study of breast implants. The purpose of this study is to determine the safety and effectiveness of the investigational Motiva Implants® SmoothSilk® Round and Round Ergonomix® in women who are undergoing primary breast augmentation, primary breast reconstruction and revision surgery.
“Study of Safety and Effectiveness of the Motiva Implants®”
Purpose: Demonstrate the safety and effectiveness profile of Establishment Labs Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision surgery, to correct or improve the results of a primary breast augmentation or reconstruction surgery.
| Indication | Breast implant surgery |
| Devices | Motiva Implants® Round Plus and Ergonomix® with or without Q Inside™ Safety Technology |
| Estimated Enrollment | 750 participants |
| Primary Purpose | Aesthetic breast augmentation and breast reconstruction |
| Study Start Date | March 2018 |
Indications
Motiva Implants®
You are being asked to volunteer to take part in a 10-year research study of breast implants. The purpose of this study is to determine the safety and effectiveness of the investigational Motiva Implants® SmoothSilk® Round and Round Ergonomix® in women who are undergoing primary breast augmentation, primary breast reconstruction and revision surgery.
All patients participating in the study will receive investigational Motiva Implants® without a cost.
*You are still responsible for the cost of surgery, anesthesiologist and other costs associated with your breast implant surgery.
Consultations for all follow-up visits will be covered by Motiva USA. Additionally, patients will receive compensation for every annual follow-up exam and accompanying patient questionnaires are completed.
After the first year follow-up, a trust fund will be assigned to each patient enrolled in the study; patients will be fully compensated upon the completion of their 10-year study.
You should ask your surgeon to clarify any terms you do not understand or ask any questions that you have
| Country | City/State | Investigator | Clinic |
|---|---|---|---|
| United States | California, Beverly Hills | Kinney, Brian | Brian M. Kinney, MD |
| United States | California, Beverly Hills | Minniti, Gerald | J. Gerald Mnniti, M.D., A Medical Corporation |
| United States | California, Santa Monica | Teitelbaum, Steven | Steven Teitelbaum MD FACS |
| United States | California, Westlake Village | Schwartz, Michael | Michael R. Schwartz, MD |
| United States | Colorado, Golden | Wolfe, Andrew | The Center for Cosmetic Surgery |
| United States | Florida, South Miami | Gottenger, Rafael | Rafael Gottenger, MD Private Practice |
| United States | Georgia, Atlanta | Losken, Albert | Emory University Hosptial Midtown |
| United States | Illinois, Chicago | Fine, Neil | Northwestern Specialists in Plastic Surgery |
| United States | Illinois, Chicago | Schierle, Clark | Northwestern Specialists in Plastic Surgery, S.C. |
| United States | Indiana, Indianapolis | Van Natta, Bruce | Meridian Plastic Surgery Center |
| United States | Louisiana, Shreveport | Wall Jr., Simeon | The Wall Center for Plastic Surgery |
| United States | Louisiana, Shreveport | Wall, Holly | The Wall Center for Plastic Surgery |
| United States | Michigan, Grand Rapids | Hammond, Dennis | Partners in Plastic Surgery of West Michigan |
| United States | Missouri, St. Louis | Caplin, David | Parkcrest Plastic Surgery |
| United States | Missouri, St. Louis | McGuire, Patricia | Parkcrest Plastic Surgery |
| United States | New Jersey, Sea Girt | Glicksman, Caroline | Glicksman Plastic Surgery |
| United States | New York, New York | Karp, Nolan | NYU Plastic Surgery Associates |
| United States | New York, New York | Keegan, Leo | Fifth Avenue Millennium Aesthetic Surgery, PLLC |
| United States | New York, New York | Harmaty, Marco | May Center for Mount Sinai Doctors |
| United States | New York, Stony Brook | Epstein, Mark | Center for Aesthetic Surgery |
| United States | Rhode Island, Providence | Zienowicz, Richard | Body by Z |
| United States | Ohio, Cleveland | Schwarz, Graham | Cleveland Clinic |
| United States | Tennessee, Nashville | Unger, Jacob | Maxwell Aesthetics, PLLC |
| United States | Texas, Fort Worth | Strock, Louis | Louis L. Strock, M.D., P.A. |
| United States | Texas, Houston | Clemens, Mark *Reconstruction Surgery | MD Anderson Cancer Center, University of Texas |
| United States | Texas, University Park | Adams, William | William P. Adams Plastic Surgey |
| United States | Washington, Vancouver | Gabriel, Allen | Allen Gabriel MD |
| Country | City | Investigator | Clinic |
|---|---|---|---|
| Germany | Düsseldorf | Scholz, Till | Plastische Chirurgie im Medienhafen |
| Sweden | Stockholm | Randquist, Charles | AB Victoriakliniken |
Investigational Motiva Implants® Round and investigational Motiva Implants® Ergonomix® are filled to 100% of the smooth shell volume.
Several technologies offered:
In consultation with each patient, the investigator will determine the appropriate implant style and size.
The look and feel of a natural breast.
Motiva Ergonomix®
Elastic and soft gel
Adapts to the natural breast shape
A more natural look and feel
Natural profile
Creating shape with a natural feel.
Motiva Round
Balanced gel elasticity and firmness
Upper-pole fullness
Younger active look
Fullness profile
What is the purpose of this study?
To demonstrate the safety and effectiveness of the Investigational Motiva Implants®.
Have the breast implants been tested before?
Although Motiva Implants are only available in the US as investigational devices in a clinical trial, these devices are not new to the global market. Actually, they are available for sale and use in 68 countries.
What are the possible interventions that I might receive during the trial?
The following interventions would be performed to all patients participating in the study: Breast implant surgery, manual chest measurements, 2D digital photography’s, 3D imaging scan and simulations, Magnetic Resonance Imaging and Ultrasound if applicable.
In the presence of complications an explanation surgery followed by a re-implantation surgery could be performed. Take in to account that additional interventions might be needed individually.
How will it be determined which interventions I receive (for example, by chance)?
All patients in the clinical trial will have the same type of interventions for different indications. In this clinical study trial there is no randomization. Take into account that additional interventions might be needed individual.
Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
All patients involved in the clinical trial will know the type of intervention they will be subjected to. The device selection will be done by the surgeon in consultation with each patient to determine the appropriate style and size, and of course, the patient’s desires will be taken in to consideration.
Properly trained research members will provide you with all the relevant information you need to make an informed decision regarding your participation in the study.
How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
Breast augmentation is an elective surgical operation intended to increase the size or volume or enhance the shape of a woman’s breasts.
With the breast implant surgery, the patients can achieve a more proportional shape and may improve self-esteem, sex life, quality of life and overall satisfaction and wellbeing. The reasons to consider breast augmentation are unique. The motivations are different and individual.
What will I have to do?
You will be been part of a 10-year clinical study. Through the yearly follow-ups, we can provide a proper assessment of your breast implants.
Additionally you will have the possibility of having board certified surgeons providing you the follow-up assistance and care that you need.
What tests and procedures are involved?
The only tests involved are regular pre-operative preparations and a pregnancy test prior to surgery. The procedures to be performed include breast augmentation surgery, 2D photography’s, 3D imaging scan and simulation, and quality of life questionnaires, Magnetic Resonance Imaging and Ultrasound if applicable. Please keep in mind that additional interventions might be needed individually.
How often will I have to visit the hospital or clinic?
You will have to visit the clinic or hospital in the following time frames:
| Follow up Visit Windows After Breast Implant Surgery | |
|---|---|
| Evaluation Visit | Window |
| 3 to 6 weeks | ±1 weeks of surgery date |
| 1 year | ±1 month of surgery date |
| 2 years | ±2 months of surgery date |
| 3-10, yearly | ±4 months |
Who will pay for my participation?
Consultations for all follow-up visits will be covered by Motiva USA. Additionally, patients will receive compensation for every annual follow-up exam and accompanying patient questionnaires completion.
Will I be reimbursed for other expenses?
You will only receive compensation for participating in the study, for more information, contact your designated area surgeon.
What type of long-term follow-up care is part of this trial?
Standard follow-up requirements after breast implant surgery.
If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
After the 10 years you can continue having your breast implants.
Who will oversee my medical care while I am participating in the trial?
Your designated board certified plastic surgeon will be in charge.
What are my options if I am injured during the study?
There are several policies and warranties for the duration of the study.
This document describes the terms, conditions and claim procedures for Motiva Implants® warranty and product replacement programs.
Information for the Patient
Before the breast implant surgery, the surgeon should explain the details of the Motiva Always Confident Warranty®; the Product Replacement Policy, to the patient, and provide the patient with a copy of this document.
In addition to explaining the terms, the surgeon should also advise the patient about possible adverse events and complications associated with Breast Implants as well as the benefits and risks of surgery with Motiva Implants® silicone breast implants according to the Informed Consent for the Clinical Trial.
Always Confident Warranty®
All Motiva Implants® silicone breast implants are covered by the Always Confident Warranty® against rupture for the first 10 years of the device lifetime.
Establishment Labs will replace the products qualified as rupture with the same or similar type as the qualifying product free of charge for the warranty period. Implantation of the replacement product, as well as any subsequent procedures, must be in strict accordance with current Motiva`s product Directions for Use, Sterile Silicone Breast Implants Motiva Implant Matrix (DOC-034 Directions For Use, DFU) and accepted surgical procedures by appropriately qualified licensed surgeons for such product to qualify for replacement.
The explanted product must be returned to Establishment Labs within 10 days of its explantation, properly decontaminated and sterilized by the surgeon, following the indications and procedures contained in the Establishment Labs S.A. Explanted Breast Implants Handling Protocol (SID-129), and any additional applicable regulations regarding biological risk. Shipping charges will be covered by Establishment Labs
Failure to abide by these terms will invalidate any claim.
Product Replacement Policy
All Motiva Implants® silicone breast implants are covered by our Product Replacement Policy in the event of capsular contracture Baker grades III and IV for a period of 10 years.
Establishment Labs will replace the products qualified as rupture with the same or similar type as the qualifying product, free of charge for ten years since the first implantation surgery. Implantation of the replacement product, as well as any subsequent procedures, must be in strict accordance with current Motiva`s product Directions for Use, Sterile Silicone Breast Implants Motiva Implant Matrix (DOC-002 Directions For Use, DFU) and accepted surgical procedures by appropriately qualified licensed surgeons for such product to qualify for replacement.
Qualifying replacement product will be sent without shipping charges. Motiva will neither provide nor pay for a non-Motiva product, nor in any event provide money for or in lieu of a Motiva replacement product.
Failure to abide by these terms will invalidate any claim.
Exclusions
Motiva Implants® silicone breast implants warranty shall not apply to any implantations performed without strict accordance to current product “Directions for Use, Sterile Silicone Breast Implants Motiva Implant Matrix” (DOC-034) and accepted surgical procedures by appropriately qualified licensed surgeons.
Motiva Implants® standard and extended warranty program do not apply to:
•Removal of intact implants for capsular contracture, Baker Grade I or Baker Grade II
•Removal of intact implants for size alteration
•Removal of intact implants due to wrinkling or rippling
•Loss of shell integrity caused by or during re-operative procedures
•Loss of shell integrity resulting from open capsulotomy or closed compression capsulotomy procedures
•Loss of shell integrity resulting from sharp instrument damage
Establishment Labs may exclude from the applicable warranty program patients with previous history of capsular contracture Baker grades III and IV
Filing a Warranty Claim
To file a claim for any warranty program the patient´s surgeon should file the warranty claim through Motiva support site at:
Rupture and Capsular Contracture Baker grades III and IV cases should have been reported Establishment Labs within the stated eligibility timeframe.
The following information is required to apply for either program product replacement approval:
• Information to document the patient’s implant information and the patient’s event description FOR302 – Complaint Notification (Customer) This document must be completed and signed by the treating surgeon. This report includes vital information that must be accurately stated, such as the device reference, series and lot numbers, volume, base, projection, expiration date and type. It also must contain a detailed description of the event being reported.
• For capsular contracture Baker grades III and IV claims: an ultrasound or an MRI scan with the correspondent technician report and photographs of the patient as clinical evidence; and the doctor’s report on the case showing the appearance of the breast prior to the explant procedure.
• For rupture claims: the explanted product is required; exceptionally when local applicable laws do not allow it please contact Establishment Labs for assistance. When local applicable laws allow it the patient must require for the surgeon to send the removed and decontaminated product following the Explanted Breast Implants Handling Protocol (SID-129), to:
Establishment Labs S.A., Coyol Free Zone and Business Park, 0 Street, Building B-25, Alajuela, Costa Rica.
For guidance on providing the necessary information and support documentation BEFORE any implant is explanted the patient or its surgeon should contact the local representative or through Motiva support site.
Establishment Labs reserves the right to cancel, change or modify the terms established in this document. Any such cancellation, change or modification will not affect the stated terms as of the date of their implantation for those already registered and covered under the existing warranty programs in effect on the date of the applicable implantation.
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