7
be thoroughly rinsed with physiological saline solution. All devices removed
from a patient’s body should be treated as potentially contaminated, either safely
disposed of or processed, and returned to Allergan as per the instructions below.
METHOD FOR REMOVING RUPTURED GEL FROM THE
SURGICAL POCKET
In the event of implant 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-gloved 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 implants must be reported and returned to
Allergan as per the instructions below.
RETURNED GOODS POLICY
Product returns and exchanges must be authorised through your Allergan
representative. Exchange value is based on time limitations. All package seals must
be intact to be eligible for return or exchange. Returned products may be subject to
a restocking charge. Certain products are non-returnable. For more information,
please contact your Allergan representative.
REPORTING AND RETURN OF EXPLANTED DEVICES
Explanted devices associated with a complaint or injury must be reported and
returned to your local Allergan representative with a Product Field Note (PFN).
In order for the explanted product to be returned to the manufacturer it must first
be decontaminated and a Decontamination Certificate completed and returned
with the explanted device within an explant return kit. Do not return device if the
patient has HIV or hepatitis or is known or suspected to carry another infectious
agent. Please notify your Allergan representative in these circumstances.
PRE-DISINFECTING INSTRUCTIONS:
Gel-filled breast implants: Do not puncture the device.
For saline-filled, gel/saline double lumen breast implants and tissue expanders
• Remove any remaining saline solution from the device and vent the device by
puncturing the shell with a needle, or nicking the shell with a scalpel. For gel-
saline devices, puncture the saline-filled lumen, only.
• Mark the puncture by circling the site with methylene blue, skin marking
pencil, or permanent marker.
Double lumen gel/saline implants that have been plugged with a Fill Tube Plug Kit
• Cut the tube approx. 1 cm from the Fill Tube Plug (implant side of the plug) and
remove saline from the device, return both plugged tubing and the device.
DISINFECTING METHODS:
Autoclave:
• DO NOT use a prevacuum autoclave or ethylene oxide sterilizer.
• Set autoclave on the “slow exhaust” or “liquid” setting.
• Autoclave by the following gravity displacement cycle: minimum of 70 minutes
at 121°C, 1kg/cm
2
(250°F, 15 psi).
• Open door slowly once the cycle is completed and allow device to cool to room
temperature before preparing for shipment.
Bleach (use only if autoclave is not available):
Note: Do not use alcohol,
Cidex
®
(glutaraldehyde), formaldehyde or other
solutions for disinfecting.
• Mix one part of household bleach (10% sodium hypochlorite) with 9 parts of
water.
• Completely submerge the explanted device in the solution for 60-120 minutes.
• Rinse thoroughly with water and dry the device.
A Product Field Note, shipping instructions, and a decontamination certificate
within an Allergan return kit is required prior to dispatch of each explanted device.
These can be obtained by contacting your local Allergan office/local distributor.
PRODUCT REPLACEMENT POLICY
In the event of non-iatrogenic loss of breast implant shell integrity within ten
years from the date of implantation, the device will be replaced with an identical
or equivalent device. To receive a replacement device, a Product Field Note (PFN)
must be completed and submitted to your Allergan representative. Explanted
devices must be returned in accordance with section above “Reporting and
Return of explanted devices”. The product replacement policy does not cover
surgical or other expenses related to rupture, deflation, cosmetic revision, capsular
contracture, or other adverse events. Contact your local Allergan representation for
specific warranty details for your region.
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. 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, however not limited to, any implied warranties of
merchantability or fitness for use.
INFORMED CONSENT
An Informed Consent Form is provided (see back of book). Please ensure that
the patient receives the information from the section “INFORMATION THAT
SHOULD BE PROVIDED TO THE PATIENT” and understands the information
provided. The patient must realise that the surgical and post-surgical risks
associated with implants cannot be completely predicted, even with the best
medical manufacturing, technology and surgical care, and accept these conditions
and limitations. Patients must fully inform their physician of their medical history,
including any and all conditions that would contraindicate implant surgery or
tissue expansion. Failure to inform their physician could result in significant
surgical and post-surgical complications. The patient must decide herself on
whether the expected benefits outweigh the said risks. If the patient decides that
the expected benefits of the proposed implant surgery outweigh the risks, then she
must take full responsibility for her choice to proceed with implant surgery. The
two-part form located at the back of this book should be completed and signed
once the patient has decided to proceed with implant surgery. This form allows
both the patient and the surgeon to retain copies for their records.
ID CARD
As part of device tracking, Allergan is providing a patient ID Card. The
information on the inside of this card (when folded) is specific to the device(s)
the patient received (patients should keep this card for their records and carry it
at all times to facilitate medical care in case of emergency). If a device is replaced,
another card will be provided for the new device. The ID Card is located at the
back of this book.
Instructions for the Surgeon:
Place one label from each product in the appropriate space on the ID Card (L or
R). These labels can be found attached to the bottom of the main inner label on
top of the inner product packaging. In the absence of a Patient Record Label, copy
the Product code, REF, SN and LOT from the package label to the space provided.
Fill in all the remaining sections. Give this entire document to the patient for her
records. See “Graphical Symbols” for explanation of symbols.
Release Date: 29 Sep 2015 00:07:57 GMT -07:00
Expires one day from 21 Dec 2015
Effective