Breast Its Shape?.................................................................
4
What is a Saline-Filled Breast Implant? ........................................................
4
Are You Eligible for Saline-Filled Breast Implants? ........................................
4
What are Important Factors for You to Consider When Deciding
to Have Saline-Filled Implants? ................................................................
5
Who Is Not Eligible for Breast Implants? .......................................................
5
What are Contraindications, Warnings and Precautions for You
to Consider?.............................................................................................
6
What Type of Breast Implants Are Available from Mentor? ............................
7
What Are Potential Breast Implant Complications?
...........................
9
Mentors Clinical Studies
........................................................................... 13
Description of Studies .................................................................................. 13
What Were the 1-Year Complication Rates from the LST? ............................ 14
Augmentation Results from SPS
.............................................................. 15
What Were the 3-Year Complication Rates from the SPS for
Augmentation Patients?............................................................................ 15
What Were the Types of Additional Surgical Procedures
Performed for Augmentation Patients? ..................................................... 16
What Were the Reasons for Implant Removal for Augmentation Patients? .... 17
What Were the Complication Rates After Implant Replacement
for Augmentation Patients? ...................................................................... 18
What Were the Breast Disease and CTD Events in
Augmentation Patients?............................................................................ 19 [3]
What Were the Benefits from the SPS for Augmentation Patients?................ 20
Augmentation Results from Post-Approval Study
............................... 20
Reconstruction Results from SPS
............................................................ 23
What Were the 3-Year Complication Rates from the
SPS for Reconstruction Patients? ............................................................. 23
What Were the Types of Additional Surgical Procedures
Performed for Reconstruction Patients?.................................................... 25
What Were the Reasons for Implant Removal for
Reconstruction Patients? .......................................................................... 26
What Were the Complication Rates After Implant
Replacement for Reconstruction Patients? ............................................... 27
What Were the Breast Disease and CTD Events in
Reconstruction Patients? .......................................................................... 28
What Were the Benefits of the SPS for Reconstruction Patients? .................. 28
Reconstruction Results from Post-Approval Study
............................. 29
Breast Augmentation Considerations
..................................................... 31
Special Considerations for Breast Augmentation........................................... 31
What Questions Do You Ask Your Surgeon about Breast Augmentation? ....... 31
Other Factors to Consider in Breast Augmentation........................................ 32
Breast Reconstruction Considerations
................................................... 35
Special Considerations for Breast Reconstruction......................................... 35
What Questions Do You Ask Your Surgeon about Breast Reconstruction?...... 41
Other Factors to Consider in Breast Reconstruction...................................... 42
If You Experience a Problem, Should You Report It?
......................... 43
What Are Other Sources of Additional Information?
........................ 44
Glossary
.......................................................................................................... 45 [4]
Saline-Filled Breast Implant Surgery:
Making an Informed Decision
So Youre Considering Saline-Filled Breast
Implant Surgery
The purpose of this brochure is to assist you in making an informed decision about
breast augmentation and breast reconstruction surgery. This educational brochure
is set up to help you talk with your surgeon, as well as provide you with general
information on breast implant surgery and give you specific details about Mentor
breast implants.
What Gives the Breast Its Shape?
The breast consists of milk ducts and glands, surrounded
by fatty tissue that provides its shape and feel. Situated
beneath the breast is the pectoralis major muscle or chest
muscle. Factors such as pregnancy (when milk glands are
temporarily enlarged), rapid weight loss, and the effects of
gravity as you age combine to stretch the skin, which may
cause the breast to droop or sag.
What Is a Saline-Filled Breast Implant?
A breast implant is a sac (implant shell) of silicone elas-
tomer (rubber), which is surgically implanted under your
chest tissues, and then filled with saline, a saltwater solution, through a valve.
Are You Eligible for Saline-Filled Breast Implants?
Implants are to be used for females for the following indications (procedures):
Breast Augmentation This procedure is done to increase the size and pro-
portions of a womans breasts. A woman must be at least 18 years old for
Fatty Tissue
Ducts
Muscle [5]
breast augmentation.
Breast Reconstruction This procedure is done to restore a womans breast
shape after a mastectomy or injury that resulted in either partial or total loss of
the breast(s), or to correct a birth defect.
What Are Important Factors for You to Consider When
Deciding to Have Saline-Filled Implants?
Whether you are undergoing augmentation or reconstruction, be aware that
breast implantation may not be a one-time surgery. You are likely to need addi-
tional surgery and surgeon visits over the course of your life.
Breast implants are not considered lifetime devices. You will likely undergo
implant removal with or without replacement over the course of your life.
Many of the changes to your breast following implantation are irreversible (can-
not be undone). If you later choose to have your implant(s) removed, you may
experience unacceptable dimpling, puckering, wrinkling, or other cosmetic
changes of the breast.
Breast implants may affect your ability to produce milk for breast feeding. Also,
breast implants will not prevent your breasts from sagging after pregnancy.
With breast implants, routine screening mammography will be more difficult,
and you will need to have additional views, which means more time and radia-
tion.
For patients who have undergone breast implantation either as a cosmetic or a
reconstructive procedure, health insurance premiums may increase, coverage
may be dropped, and/or future coverage may be denied. Treatment of complica-
tions may not be covered as well. You should check with your insurance compa-
ny regarding these coverage issues.
Augmentation Insurance does not cover breast augmentation and may not
cover reoperation (additional surgery) and additional surgeons visits following
augmentation.
Reconstruction Most insurance covers the first breast reconstruction opera-
tion. Insurance coverage for reoperation procedures or additional surgeons vis-
its following reconstruction may not be covered, depending on the policy.
Who Is Not Eligible for Breast Implants?
Implants are not to be used for:
Women with existing malignant or pre-malignant cancer of your breast without [6]
adequate treatment
Women with active infection anywhere in your body
Augmentation in women who are currently pregnant or nursing
What are Contraindications, Warnings, and Precautions for
You to Consider?
Surgical practices that are contraindicated in breast implantation because
they may damage the shell and cause deflation/rupture:
Placement of drugs/substances inside the implant other than sterile saline
Any contact of the implant with Betadine
®
*
Injection through implant shell
Alteration of the implant
Stacking of implants: more than one implant per breast per breast pocket
Safety and effectiveness have not been established in patients with the follow-
ing conditions:
Autoimmune diseases such as lupus and scleroderma
Conditions that interfere with wound healing and blood clotting
A weakened immune system (for example, currently receiving immunosuppres-
sive therapy)
Reduced blood supply to breast tissue
*Betadine is a registered trademark of Purdue Frederick Company.
Further considerations:
Pre-implantation Mammography You may wish to undergo a preoperative
mammogram and another one at 6 months to 1 year after implantation to
establish a baseline.
Interference with Mammography The implant may interfere with finding
breast cancer during mammography and also may make it difficult to perform
mammography. Therefore, it is essential that you tell your mammography tech-
nologist that you have an implant before the procedure. The technologist can
use special techniques to minimize the possibility of rupture and to get the best
possible views of the breast tissue. Because the breast is squeezed during
mammography, it is possible for an implant to rupture during the procedure. [7]
More x-ray views are necessary with these special techniques; therefore,
women with breast implants will receive more radiation. However, the benefit
of the mammogram in finding cancer outweighs the risk of the additional x-
rays.
Dis