Memory Gel and Shape Combined Cohort



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:September 1, 2016
End Date:September 1, 2028
Contact:Patricia Chen
Email:pchen126@its.jnj.com

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MemoryShape® and MemoryGel® Breast Implants Post Approval New Enrollment Study ("Glow Study")

The purpose of this study is to collect additional post-approval clinical data on the
long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary
or revisional breast augmentation and primary or revisional breast reconstruction.

The post-approval study will include 2518 women undergoing breast augmentation or
reconstruction with MemoryShape or MemoryGel Breast Implants. Four cohorts will be included:
primary augmentation, revision-augmentation, primary reconstruction, and
revision-reconstruction. For the purpose of assessing rheumatological and neurological signs
and symptoms, a control group of 300 women will be selected from the participating
investigators' practices, who are undergoing an aesthetic surgery other than breast implant
surgery. Breast implant patients and the concurrent control group patients will be followed
for 10 years. Baseline and operative data will be collected at the beginning of the study,
and follow-up data will be collected annually for 10 years through online questionnaires.

Inclusion Criteria MemoryShape and MemoryGel Breast Implant Patients:

1. Is a candidate for breast augmentation with MemoryShape or MemoryGel Breast Implants
and is at least 22 years old (primary or revision) OR is a candidate for breast
reconstruction (primary or revision) with MemoryShape or MemoryGel Breast Implants and
is at least 18 years old;

2. Signs an Acknowledgement of Informed Decision from the patient brochure;

3. Signs an Informed Consent Form, including an Authorization to Disclose Health
Information and Release Medical Records;

4. Agrees to answer baseline questions;

5. Agrees to authorize return of the device(s) to Mentor if the device is explanted;

6. Agrees via Informed Consent to comply with study follow-up, including following the
surgeon's standard of care for office visits and responding to questionnaires in their
entirety; and

7. Has a valid e-mail address and access to the internet to complete online
questionnaires.

Exclusion Criteria MemoryShape and MemoryGel Breast Implant Patients:

1. Has active infection anywhere in her body;

2. For augmentation patients, has a history of cancer of any kind, except non-melanoma
skin cancer; for reconstruction patients, has a history of cancer of any kind, except
non melanoma skin cancer or adequately treated breast cancer;

3. Has a confirmed diagnosis of connective tissue disease or neurological disease OR is
currently being evaluated for symptoms suggestive of connective tissue disease or
neurological disease;

4. Is currently pregnant or nursing;

5. Is planning on undergoing or has undergone bariatric surgery; or

6. Is planning on undergoing experimental procedures or procedures with investigational
products/devices during the study period that in the opinion of the investigator could
compromise the results of this study.

Inclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients:

1. Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow
lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty;
may not include silicone implants) and is at least 22 years of age;

2. Signs an Informed Consent Form, including an Authorization to Disclose Health
Information and Release Medical Records;

3. Agrees to answer baseline questions;

4. Agrees via Informed Consent to comply with study follow-up, including responding to
questionnaires in their entirety; and

5. Has a valid e-mail address and access to the internet to complete online
questionnaires.

Exclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients:

1. Has ever had unilateral or bilateral breast implants (including breast tissue
expanders);

2. Expects to undergo breast implant surgery during the study period;

3. Has ever had silicone implants anywhere in her body;

4. Has active infection anywhere in her body;

5. Has a history of cancer of any kind, except non-melanoma skin cancer;

6. Has a confirmed diagnosis of connective tissue disease or neurological disease OR is
currently being evaluated for symptoms suggestive of connective tissue disease or
neurological disease;

7. Is currently pregnant or nursing;

8. Is planning on undergoing or has undergone bariatric surgery; or

9. Is planning on undergoing experimental procedures or procedures with investigational
products/devices during the study period that in the opinion of the investigator could
compromise the results of this study.
We found this trial at
75
sites
4200 North Federal Highway
Fort Lauderdale, Florida 33308
Principal Investigator: Don R Revis, Jr, MD
Phone: 954-630-2009
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Alcoa, Tennessee 37701
Principal Investigator: Stephen M. Becker, MD
Phone: 865-238-6400
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Alpharetta, Georgia 30005
Principal Investigator: Joseph G. Bauer, MD
Phone: 770-667-0904
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Alpharetta, GA
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Apple Valley, California 92307
Principal Investigator: Ali Tehrani, MD
Phone: 760-240-2444
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Apple Valley, CA
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5670 Peachtree Dunwoody Road
Atlanta, Georgia 30342
Principal Investigator: Diane Z Alexander, MD
Phone: 404-851-1998
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Atlanta, GA
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Atlanta, Georgia 30342
Principal Investigator: Amy K. Alderman, MD
Phone: 470-381-3610
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Bala-Cynwyd, Pennsylvania 19087
Principal Investigator: Paul Glat, MD
Phone: 610-200-6657
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Berkeley Heights, New Jersey 07922
Principal Investigator: Peter Hyans, MD
Phone: 908-277-8759
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Berkeley Heights, NJ
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Beverly Hills, California 90210
Principal Investigator: Jaime Schwartz, MD
Phone: 310-882-5454
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140 Village Street
Birmingham, Alabama 35242
Principal Investigator: William Hedden, MD
Phone: 205-980-1744
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Birmingham, Michigan 48009
Principal Investigator: Mohammad Ali, MD
Phone: 248-335-7200
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Birmingham, MI
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Bismarck, North Dakota 58503
Principal Investigator: D'arcy Honeycutt, MD
Phone: 701-530-8450
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Bloomfield, Michigan 48304
Principal Investigator: Ellen A. Janetzke, MD
Phone: 248-258-5100
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Bloomfield, MI
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Boca Raton, Florida 33431
Principal Investigator: David Bogue, MD
Phone: 561-886-1002
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Burbank, California 91505
Principal Investigator: Susan E. Downey, MD
Phone: 818-748-4930
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Burnsville, Minnesota 55337
Principal Investigator: Joseph M. Gryskiewicz, MD
Phone: 952-435-0177
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Charlotte, North Carolina 28277
Principal Investigator: Miguel A. Yanez, MD
Phone: 704-542-2220
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Charlotte, North Carolina 28277
Principal Investigator: Andrew Gear, MD
Phone: 704-771-1747
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Chattanooga, Tennessee 37403
Principal Investigator: Mark Brzezienski, MD
Phone: 423-756-7134
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Columbus, Ohio 43213
Principal Investigator: Bivik Shah, MD
Phone: 614-322-2500
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398 Copperfield Boulevard Northeast
Concord, North Carolina 28025
Principal Investigator: David Klein, MD
Phone: 704-784-4008
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Concord, NC
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Coral Gables, Florida 33134
Principal Investigator: Jason Altman, MD
Phone: 305-446-7700
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Corte Madera, California 94925
Principal Investigator: Khashayar Mohebali, MD
Phone: 415-927-7660
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Draper, Utah 84020
Principal Investigator: Richard D. Fryer, MD
Phone: 801-571-2020
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Fayetteville, Arkansas 72703
Principal Investigator: R. Douglas Vanderpool, MD
Phone: 479-571-8585
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Fayetteville, Georgia 30214
Principal Investigator: Joseph Raniere, Jr., MD
Phone: 770-461-4000
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Fountain Valley, California 92708
Principal Investigator: Thuan Nguyen, MD
Phone: 714-444-4011
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3312 Fall Hill Avenue
Fredericksburg, Virginia 22401
Principal Investigator: Howard Heppe, MD
Phone: 540-371-7730
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Gastonia, North Carolina 28054
Principal Investigator: Parag Butala, MD
Phone: 704-866-7576
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Gastonia, North Carolina 28054
Principal Investigator: Benson Timmons, IV, MD
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Gilbert, Arizona 85295
Principal Investigator: Joshua Olson, MD
Phone: 480-466-7355
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Grand Rapids, Michigan 49546
Principal Investigator: Dennis Hammond, MD
Phone: 616-464-4420
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Greer, South Carolina 29650
Principal Investigator: James E. Lovett, III, MD
Phone: 864-968-9636
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Henderson, Nevada 89074
Phone: 702-897-1330
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Hickory, North Carolina 28602
Principal Investigator: Steven A. Siciliano, MD
Phone: 828-325-9849
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Houston, Texas 77098
Principal Investigator: Michael E. Ciaravino, MD
Phone: 713-627-1200
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1602 Colonial Parkway
Inverness, Illinois 60067
Principal Investigator: Christopher Pelletiere, MD
Phone: 846-358-9444
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Jacksonville, Florida 32257
Principal Investigator: David N. Csikai, MD
Phone: 904-730-5052
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Lehi, Utah 84043
Principal Investigator: Michael D. Marion, MD
Phone: 801-331-8554
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Lone Tree, Colorado 80124
Principal Investigator: Jeremy Z. Williams, MD
Phone: 303-706-1100
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Long Island City, New York 11106
Principal Investigator: Jason I. Altman, MD
Phone: 718-395-5222
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Marietta, Georgia 30060
Principal Investigator: Michael J. McNeel, MD
Phone: 770-425-0118
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Mesa, Arizona 85297
Principal Investigator: Alvaro Testa, Jr, MD
Phone: 480-850-2098
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Miami, Florida 33173
Principal Investigator: Jose Perez-Gurri, MD
Phone: 305-596-2228
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8720 North Kendall Drive
Miami, Florida 33176
Principal Investigator: Christopher Craft, MD
Phone: 305-596-9700
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Miami, Florida 33166
Principal Investigator: Stephanie A. Stover, MD
Phone: 786-713-1588
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Miami, Florida 33146
Principal Investigator: Sean A. Simon, MD
Phone: 305-668-0496
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Nashville, Tennessee 37215
Principal Investigator: Michael Burgdorf, MD
Phone: 615-567-5716
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Newport Beach, California 92660
Principal Investigator: Thomas D. Toohey, MD
Phone: 949-759-8700
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Newport Beach, California 92660
Principal Investigator: Nirav B. Savalia, MD
Phone: 949-759-0980
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Newport News, Virginia 23606
Principal Investigator: Peter J. Vonu, MD
Phone: 757-337-2660
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Norfolk, Virginia 23510
Principal Investigator: Robert H. Schnarrs, MD
Phone: 757-274-4000
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1535 Lake Cook Road
Northbrook, Illinois 60062
Principal Investigator: Michael Epstein, MD
Phone: 847-205-1680
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Oak Lawn, Illinois 60453
Principal Investigator: Samir Shah, MD
Phone: 708-424-3999
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Oceanside, California 92056
Principal Investigator: Gregory Park, MD
Phone: 760-655-1415
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11101 Hefner Pointe Drive
Oklahoma City, Oklahoma 73120
Principal Investigator: Tim Love, MD
Phone: 405-751-5683
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Ontario, California 91764
Principal Investigator: Ka Ming Li, MD
Phone: 909-581-7777
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Phoenix, Arizona 85014
Principal Investigator: Ramon A. Robles, MD
Phone: 602-737-0824
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Portsmouth, New Hampshire 03801
Principal Investigator: Lawrence N. Gray, MD
Phone: 603-431-8819
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1630 Wilkes Ridge Parkway
Richmond, Virginia 23233
Principal Investigator: Darrin Hubert, MD
Phone: 804-285-4115
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Rome, Georgia 30161
Phone: 706-378-0200
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Saint Louis, Missouri 63141
Principal Investigator: David Caplin, MD
Phone: 314-569-0130
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Savannah, Georgia 31405
Principal Investigator: Richard Greco, MD
Phone: 912-355-8000
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Scottsdale, Arizona 85260
Principal Investigator: Joseph Berardi, MD
Phone: 480-397-0711
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8994 East Desert Cove Avenue
Scottsdale, Arizona 85260
Principal Investigator: Marc Malek, MD
Phone: 480-551-2040
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Tallahassee, Florida 32308
Principal Investigator: Ben Kirbo, MD
Phone: 850-877-2000
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4214 North Habana Avenue
Tampa, Florida 33607
Principal Investigator: Joshua Halpern, MD
Phone: 813-872-2696
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Traverse City, Michigan 49684
Principal Investigator: Steven Thomas, MD
Phone: 231-929-7700
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85 East Big Beaver Road
Troy, Michigan 48083
Principal Investigator: William Stefani, MD
Phone: 586-779-3030
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Troy, Michigan 48084
Principal Investigator: Danielle DeLuca-Pytell, MD
Phone: 248-273-7700
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Tuscaloosa, Alabama 35406
Principal Investigator: Ross Bunch, MD
Phone: 205-349-0049
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4031 Massillon Road
Uniontown, Ohio 44685
Principal Investigator: Steven Carp, MD
Phone: 330-899-1500
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Visalia, California 93291
Principal Investigator: Alex N. Lechtman, MD
Phone: 559-738-7572
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Winston-Salem, North Carolina 27103
Principal Investigator: George A. Lawson, III, MD
Phone: 336-765-8620
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