Directions for Use
Directions for Use
CAUTION: U.S. Federal law restricts this device to sale by or on the
order of a licensed physician.
Re-sterilizable Breast Implant Sizers
Location of Orientation Marks
NATRELLE ® 410 RE-STERILIZABLE BREAST IMPLANT SIZER
NATRELLE ® 410 Smooth Silicone Gel-Filled Re-sterilizable Sizer.
Posterior View (6 Marks)
Posterior View (5 Marks)
NATRELLE ® Re-sterilizable Round Silicone Breast Implant Sizers are
used during breast augmentation or reconstruction procedures to assist
the surgeon in determining the appropriate size of a breast implant
to use. Prior to using the NATRELLE ® Re-sterilizable Sizer, the
physician should be familiar with all of the literature associated with
the breast prosthesis to be implanted.
NATRELLE ® ROUND RE-STERILIZABLE BREAST IMPLANT SIZER
NATRELLE ® Smooth Silicone Gel-Filled Re-sterilizable Sizer.
Refer to the Round Silicone Breast Implant Directions for Use for
information on contraindications.
NATRELLE ® Re-sterilizable Breast Implant Sizers are designed
for temporary intraoperative placement, to assist in determining
the desired breast implant volume. They are used during breast
augmentation or reconstruction procedures. The NATRELLE ® Round
Re-sterilizable Sizers are constructed from a smooth silicone elastomer
shell and are filled with responsive gel. The NATRELLE ® 410
Re-sterilizable Breast Implant Sizers are constructed from a smooth
silicone shell and are filled with a gel that maintains the shape.
The NATRELLE ® 410 and Round Re-sterilizable Sizers have been
designed to match the NATRELLE ® Style 410 breast implants and the
NATRELLE ® Round Silicone breast implants, respectively.
Re-sterilizable Breast Implant Sizers are intended to be used only by a
qualified surgeon. Before proceeding with surgery, the surgeon should
inform the patient of the following warnings.
Patients should be advised that the Sizer may rupture, releasing
silicone gel into the surrounding cavity.
Causes of rupture include:
• Damage by surgical instruments, such as nicks, slices, or
• Other trauma during surgery, such as improper handling or
Do not insert or attempt to repair a damaged sizer.
NOTE: NATRELLE ® Re-sterilizable Breast Implant Sizers are supplied
sterile and intended for a maximum of ten additional reuses following
cleaning, disinfection and sterilization after each use. They are designed
for temporary use and should not be permanently implanted.
SIZER DESIGN FEATURES
• NATRELLE ® Re-sterilizable Sizers are supplied sterile and can be
re-sterilized a maximum of ten times.
• NATRELLE ® 410 Re-sterilizable Sizers contain Soft Touch gel
and include orientation marks. (see Figure 1)
Infection, Necrosis, Hematoma/Seroma & Pain
Infection, necrosis, hematoma/seroma and pain, are
complications which may occur following any type of surgery
and may require further investigation and treatment.
Minute quantities of silicone may diffuse through the elastomer
envelope of the Sizer. NATRELLE ® Breast Implant Sizer shells
feature a patented barrier coat between two layers of silicone
elastomer to minimize gel diffusion.
DO NOT alter the Re-sterilizable Sizer. Alteration to the original
design and fabrication voids all warranties, express or implied.
NEVER, under any circumstances attempt to re-sterilize using ethylene
oxide, which is known to cause adverse tissue reaction if not completely
removed from the device.
NATRELLE ® Re-sterilizable Sizers are temporary devices, and are
not intended to be used as a permanent implant. They should only be
used for temporary intra-operative placement, to assist the surgeon
in permanent implant size selection.
HOW TO OPEN STERILE PRODUCT PACKAGE
Remove the Sizer from its packages in an aseptic environment and using
talc-free gloved hands.
DO NOT expose the Sizer to lint, talc, sponge, towel, skin oils or other
1. Peel open the outer package.
2. Invert the outer package over the sterile field, allowing the sealed inner
package to gently fall into the field.
3. Peel open the inner package.
4. Gently retrieve the Sizer.
Prior to use, keep the Sizer covered in the inner package, to prevent
contact with airborne and surgical field particulate contaminants.
INSTRUCTIONS FOR USE
Allergan relies on the surgeon to know and follow the proper surgical
procedures with Silicone Gel-Filled Sizers. The surgeon can use the
Sizer to evaluate the correct implant size for each implantation. Planning
should include clear delineation of aesthetic goals to ensure mutual
understanding between surgeon and patient. The surgeon should observe
current and accepted techniques to minimize the risk of adverse, and
potentially disfiguring reactions.
IMPORTANT: Please ensure that the serial number, lot number, and
catalogue number of device are recorded in all patient documentation
and in the Sizer Re-sterilization Record to ensure product
identification and device traceability. The serial number is located on
the outer package label.
NOTE: Additional sizers of various sizes should be available to assist
the surgeon in determining the appropriate size.
Product labels are supplied within the internal product packaging of
each NATRELLE ® Re-sterilizable Sizer. The product labels provide
specific information, which allows product identification. In addition
to the product labels, a Sizer Re-sterilization Record Card is also
provided with the product for the recording of details of subsequent
re-sterilization cycles carried out on the sizer.
PRODUCT EXAMINATION PRIOR TO USE
Prior to use, examine the Re-sterilizable Sizer for any evidence of damage
or particulate contamination.
DO NOT use any Re-sterilizable Sizer that may appear to have leaks,
nicks or rupture.
DO NOT use damaged or contaminated Re-sterilizable Sizers.
These products are intended for ten (10) additional uses after initial use
and only after adequate cleaning, disinfecting and re-sterilization by
DO NOT reuse Re-sterilizable Sizers more than ten (10) times after
DO NOT use disinfectant on the Re-sterilizable Sizer.
Please ensure that a record of the reprocessing details of the Sizer is
documented to ensure product identification and device traceability.
DO NOT use Re-sterilizable Sizers that have been damaged or deformed
during previous surgical operations.
Ensure incision is sufficiently large to facilitate insertion and avoid damage
to the device. The Sizer can be inserted/removed several times to assist
with size selection of the permanent implant.
DO NOT damage the Re-sterilizable Sizer with sharp surgical
instruments such as needles and scalpels, blunt instruments such as
clamps and forceps, or by overhandling and manipulation during
introduction into the surgical pocket.
Each Sizer is supplied sterile in a sealed, double package. Sterility of
the Sizer is maintained only if the packages, including the package
seals, are intact. Avoid prolonged exposure to extreme storage
conditions. We recommend that these devices are stored at ambient
room temperatures, at atmospheric pressure and in dry conditions away
from direct sunlight.
DO NOT use the product if the packages or seals have been damaged.
DO NOT reprocess product under a non-validated procedure.
DO NOT contact the Sizer with disposable, capacitor-type cautery
devices as damage to the device may result.
DO NOT use excessive force during placement of the Re-sterilizable
Sizer, especially with 410 Soft Touch gel-filled shaped Re-sterilizable
Sizers. Silicone gel may be deformed due to over manipulation, resulting
in deformation of the anatomical shape.
NOTE: Sizers are for sizing purposes only and are not for permanent
METHOD FOR REMOVING RUPTURED GEL FROM THE
In the event of Re-sterilizable Sizer rupture, the following technique is
useful for removal of the gel mass. Wearing double talc-free surgical
gloves on one hand, use the index finger to penetrate the gel mass.
With the other hand, exert pressure on the breast to facilitate
manipulation of the gel mass into the double-glove hand. Once the
gel is in hand, pull the outer glove over the gel mass and remove. To
remove any residual gel, blot the surgical pocket with gauze sponges.
Avoid contact between surgical instruments and the gel. If contact
occurs, use isopropyl alcohol to remove the gel from the instruments.
Ruptured Sizers must be reported and returned to Allergan. In the event
of Re-sterilizable Sizer rupture, contact Allergan’s Product Surveillance
Department at 1.800.624.4261
Automated Washer and Disinfector
Alternatively, process the devices in an automated washer-disinfector
(Miele Model #G7835) using a cycle program such as the Miele
G7835 “Intense Cycle” for cleaning & rinsing:
• Pre-wash with hot tap water at > 55°C for 1 minute
• Wash cycle for 3 minutes at > 85°C using NeoDisher FA or
equivalent caustic detergent.
• Neutralize for 1 minute at > 10°C with NeoDisher Z (neutralizer
• Rinse two times with DI water at > 10°C (1 minute and then 2 minutes)
• Rinse one time with DI water at > 80°C for one minute
The devices are to be placed directly on each shelf (a maximum of
4 largest size RSS per shelf). The devices can be cleaned with any
basic detergent similar to NeoDisher ® FA (at any concentration).
Use of this detergent in this automated washer will result in detergent
residues below detection limits.
INSTRUCTIONS FOR REPROCESSING
Re-sterilizable Sizers are intended for a maximum ten (10) additional
uses after initial use following validated procedures for cleaning,
disinfecting and re-sterilization. Complete Sizer Sterilization Record
Card provided with the device after each re-sterilization process.
The name of person performing the re-sterilization and date of
re-sterilization should be recorded on the card. Translations of the text
on the Sterilization Record Card are provided on the reverse side of
the card. The Sizer Sterilization Record Card should accompany the
device at all times.
Visually inspect the devices for any signs of gel leakage or tears in the
device shell. This can be done without the aid of any magnification
equipment. If there are no signs of physical damage, the device may
then be wrapped and sterilized as noted below.
STERILIZATION PROCEDURE (INCLUDING PRION
Double wrap Re-sterilizable Sizer in suitable autoclave wrapping
material loosely enough to allow for expansion during autoclaving,
such as CSR sterilization wrap (e.g. Kimgaurd KC series or
DuraBlue ®), place in autoclave and process under the following
validated autoclave cycle before subsequent re-use:
CLEANING AND DISINFECTION
Directly after use, place the device into a basin, cover with purified
water (DI, RO, or WFI) and transport to central processing. Hand
wash silicone-filled Re-sterilizable Sizer for a minimum of fifteen
(15) minutes with an anionic-enzymatic type detergent, equivalent to a
2% Multi-Terge™ solution, which should be discarded after each use.
Rinse with warm (between 37°C and 43°C) running deionized water
for a minimum of one (1) minute to remove detergent residuals.
After cleaning, disinfect using a glutaraldehyde solution with a
working concentration of 2 – 3.4% (i.e. Cidex ®, Cidex-Plus ®,
or equivalent). Immerse the device in the solution for at least 60
minutes. Discard disinfection solution after each use. Rinse in flowing
deionized water for at least one (1) minute. Dry with a clean smooth
absorbent cloth. Place the disinfected device in a sealed clean
container until ready for autoclaving. Alternatively, the device may
be disinfected using 7% peracetic acid. Immerse the device in this
solution for 1-10 minutes. Discard the solution after each use. Rinse
in flowing tap water for at least (1) one minute. Dry with a clean
smooth absorbent cloth and place the disinfected device in a sealed
clean container until ready for autoclaving.
1. Gravity-Displacement Cycle:
Eighteen (18) minutes minimum
30 minutes minimum*
2. Pulse Vacuum or Prevacuum Cycle:
4 at a maximum of 75 mBar
Eighteen (18) minutes minimum
30 minutes minimum*
* Dry times vary with load composition (more wrapped goods will increase the
drying time) and exhaust efficiency of the sterilizer. The user should verify this
time with their specific equipment and loads.
Decontaminate by one of the following gravity displacement
1. Minimum of 40 minutes at 270°F, 30 psi (132°C, 2kg/cm2)
2. Minimum of 70 minutes at 250°F, 15 psi (121°C, 1kg/cm2).
After decontamination the Re-sterilizable Sizer should be prepared
for shipping, by carefully packaging the autoclavable bag/pouch
containing the Sizer in such a way to prevent damaging the device
Note: Do not use a prevacuum autoclave or orthylene oxide
The decontamination instructions provided are to be used only
as a guide. The autoclave must be set on the “slow exhaust”
or on “liquids” setting. Open the door slowly following
decontamination cycle to allow the pressure to equalize.
The Sizer must be destroyed and not re-used after use if the patient
is suspected of having Creuzfeld-Jakob Disease (CJD), or a risk
factor such as previous treatment with Human Growth Hormone,
neurological surgery, or genetic history (familial CJD).
The sterilization cycle above has been demonstrated effective when
the Re-sterilizable Sizer mass to autoclave chamber volume ratio does
not exceed 7100g/m3. Examples of mass to autoclave volume are:
Maximum Total Mass of Sizers
Volume of Autoclave Sterilizer
3600g 0.51m3 (18.0ft3)
2700g 0.41m3 (14.5ft3)
1800g 0.31m3 (10.9ft3)
Allow Sizer device to dry in the autoclave until outer wrap is entirely
dry. Do not use a vacuum assisted drying cycle. The wrapped device
should be placed in a covered container to minimize collection of
air-borne contaminants. Allow for complete cooling of Re-sterilizable
Sizer after sterilization and before subsequent re-use.
LIMITED WARRANTY, LIMITATION OF LIABILITY, AND
DISCLAIMER OF OTHER WARRANTIES
Allergan warrants that reasonable care was used in the manufacture
and production of this product. Because Allergan has no control
over the conditions of use, patient selection, surgical procedure,
post-surgical stresses, or handling of the device after it leaves our
possession, Allergan does not warrant either a good effect or against
an ill effect following its use. Allergan shall not be responsible for
any incidental or consequential loss, damage or expenses directly or
indirectly arising from use of this product. Allergan’s sole responsibility
in the event that Allergan determines the product was defective
when shipped by Allergan, shall be replacement of the product. This
warranty is in lieu of and excludes all other warranties not expressly
set forth herein, whether express or implied by operation of law, or
otherwise, including, but nor limited to, any implied warranties of
merchantability or fitness of use.
After autoclaving, discolouration of the gel may occur and/or air
bubbles might appear in the gel. These changes do not affect the
integrity or purpose of the Gel Sizer.
Store the wrapped and autoclaved device in a sealed clean container
until ready for use. Re-use the sizer within 30 days after autoclaving.
DISPOSAL OF USED RSS
After the RSS has been sterilized a maximum of 10 times, it must be
disposed of. Disposal is the responsibility of the owner, and must be
performed according to local, state, and federal regulations.
RETURNED GOODS POLICY
Product returns and exchanges must be authorized through your
Allergan representative. For more information, please contact your
To order directly or for product information, please contact your local
Allergan representative or the Allergan Customer Care Department at
REPORTING COMPLAINTS AND RETURN OF
Re-sterilizable Sizers associated with a complaint or injury must be
reported and returned to Allergan. Please contact Allergan’s Product
Surveillance Department at 800.624.4261 for return instructions. The
Re-sterilizable Sizer if used, must be decontaminated and properly
packaged before return.
Preparation of the Device for Decontamination
1. Carefully place the Sizer into an autoclavable bag/pouch with
an indicator to indicate completion of the sterilization cycle.
2. Place this pouch containing the Sizer into an outer autoclavable
CHECK FOR LEFT BREAST USE
CHECK FOR RIGHT BREAST USE
STERILE, DRY HEAT STERILIZED,
DATE OF STERILIZATION, YEAR & MONTH
USE BY, YEAR & MONTH
ATTENTION, SEE INSTRUCTIONS FOR USE
ROUND DIAMETER OF SIZER
ROUND SIZER PROJECTION
ANATOMICAL SIZER HEIGHT
ANATOMICAL SIZER WIDTH
ANATOMICAL SIZER PROJECTION
DO NOT USE IF PACKAGE IS DAMAGED
Irvine, CA 92612 USA
L3776-01 Rev.02 06/2015
™ and ® marks owned by Allergan, Inc. All rights reserved. © 2015 Allergan, Inc., Irvine, CA