Motiva Clinical Trial Patient Information

How Much Will my Breast Augmentation cost under the clinical trial?

By participating in the Motiva Implant Clinical Trial, you are agreeing to receive free breast implants the day of surgery with follow up visits for the following 10 years. You will still be responsible for covering the cost of the surgery as discussed with your surgeon. Contact our office today to learn more and schedule your consultation.

Patient Compensation After Surgery

As a participant in this clinical trial, you are agreeing to annual follow up visits for 10 years after surgery. You will be compensated with a Cash Bonus and Trust Fund which varies based upon your procedure. Patients who are receiving Primary Breast Augmentation and Revision Augmentation are in Group 1, while patients who are receiving Primary Breast Reconstruction and Revision Reconstruction are in Group 2.

Group 1: Compensation for Patients Undergoing Primary Breast Augmentation and Revision Augmentation Surgery
Patients participating in the Study will receive the following compensation:
1. Paid consultations for all follow-up visits with their treating study doctors, to evaluate the Motiva Implants ™.
2. A cash bonus as described in the table below, to be paid to the Patient after every follow-up visit:
Primary Augmentation & Revision Cash Bonus
3. After the first annual follow up visit (Year 1), Motiva USA will deposit into the trust fund the full amount of $750, corresponding to the total of all trust fund installments, according to the table below. With every annual follow up visit the patient will vest the corresponding amount.
Primary Augmentation & Revision Trust Fund
4. If a patient drops out of the Study before completion, the total $750 corresponding to her in the trust fund will be pooled and divided equally among the patients that finish the study. Additionally, any patient who misses two consecutive annual visits will be considered lost to follow up and will only receive the cash payment for the study visits attended and keep the implants. Only patients that complete the 10-year follow-up will receive the total of all trust fund installments.
5. Both, cash bonuses and the total of the Trust Fund Installments, will be paid directly to the patient.
6. If a patient misses a follow-up visit and/or drops out of the Study, she will not receive the remaining cash bonuses or the total of the Trust Fund Installments but will keep the breast implants at no charge.

Group 2: Compensation for Patients Undergoing Primary Breast Reconstruction and Revision Reconstruction Surgery
Patients participating in the Study undergoing Primary breast reconstruction and revision
surgery will receive the following compensation:
1. Paid consultations for all follow-up visits with their treating study doctors, to evaluate the Motiva Implants ™.
2. A cash bonus as described in the table below, to be paid to the Patient after every follow-up visit:
Reconstruction & Revision Cash Bonus
3. After the first annual follow up visit (Year 1), Motiva USA will deposit into the trust fund the full amount of $950, corresponding to the total of all trust fund installments, according to the table below. With every annual follow up visit the patient will vest the corresponding amount.
Reconstruction & Revision Trust Fund
4. After the Study is finalized and the patient has attended all follow up visits, she will receive the total of all Trust Fund Installments.
5. If a patient drops out of the Study before completion, the total $950 corresponding to her in the trust fund will be pooled and divided equally among the patients that finish the study. Additionally, any patient who misses two consecutive annual visits will be considered lost to follow up and will only receive the cash payment for the study visits attended and keep the implants. Only patients that complete the 10-year follow-up will receive the total of all trust fund installments.
6. Both, cash bonuses and the total of the Trust Fund Installments, will be paid directly to the patient.
7. If a patient misses a follow-up visit and/or drops out of the Study, she will not receive the remaining cash bonuses or the total of the Trust Fund Installments but will keep the breast implants at no charge.

Schedule for Patient Visits Following Surgery

Following surgery, patients will return to our office for follow up visits for 10 years. The schedule for these visits is as follows:

Schedule for Patient Visits

MRIs After Surgery

The FDA recommends that all patients should have regular MRI screenings throughout their lifetime to screen for silent rupture, even if they are not having any apparent problems. Patients should go for their first MRI 3 years after surgery, and then repeatedly every 2 years following.

MRI Sub-Study

As part of the Motiva Clinical Trial, 250 patients will be divided into 7 MRI sites to participate in an MRI Sub-Study. The  MRI  Sub-Study population will be a subset of the treated population selected to obtain MRIs at 1, 2, 4, 6, 8, and 10 years. It will be used for the analysis of rupture. Motiva USA will cover the cost of the patients MRIs. Any patient not chosen as part of the Sub-Study will be responsible for the cost of their own MRIs.

To learn more about the Motiva Implants® clinical trial in the United States from Establishment Labs, click here.

Ready To
Get Started?

CONTACT US

Request a Consultation

Quick Contact

  • This field is for validation purposes and should be left unchanged.
MEMBER OF AMERICAN
BOARD OF PLASTIC SURGEONS

MEMBER OF AMERICAN SOCIETY
FOR AESTHETIC PLASTIC SURGERY

ACCREDITED BY THE
JOINT COMMISION

AMERICAN BOARD OF PLASTIC
SURGERY CERTIFICATION



NEW PATIENT CONSULTATIONS, INJECTABLES,
NON-SURGICAL PROCEDURES AND POST-OP CARE
Epstein Plastic Surgery
2500 Nesconset Hwy, #8A
Stony Brook, NY 11790