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Introduction to
NagorEnhance®
Nagor’s commitment to providing the highest quality
silicone mammary implants is demonstrated by their
ongoing research and development, with investment in
the most modern manufacturing processes supported by
the most demanding of quality control management.
The Nagor brand has developed an enviable world-wide
reputation for reliability and product durability,
which is reflected in Nagor’s existing standard,
indefinite-term product warranty against
manufacturing defects.
As part of our ongoing commitment to excellence, we
are pleased to supplement this standard,
manufacturing defects warranty, with the
NagorEnhance® Patient Warranty. |
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• The
NagorEnhance® Patient Warranty is Free of
Charge to patients.
• The
NagorEnhance® Patient Warranty is a no-fault
warranty.
• The
NagorEnhance® Patient Warranty is an
indefinite term warranty against rupture of any
Nagor mammary implant.
• The
NagorEnhance® Patient Warranty is an
indefinite term warranty against severe capsular
contracture occurring with any Nagor mammary
implant.
• The
NagorEnhance® Patient Warranty is available to
patients who receive Nagor mammary implants within
specified countries* and who register with the
programme in accordance with the programme
terms and
conditions.
A copy of “It’s your choice …” (Nagor’s informed
consent booklet) is provided with every Nagor
implant supplied, and should be given to the patient
after discussion between the surgeon and patient.
The key criteria for free of charge replacement
implant under the terms and conditions of the
NagorEnhance® Patient Warranty are as follows:
Product & Events Covered
•
NagorEnhance® Patient Warranty applies to all
listed Nagor mammary implants that are implanted
within specified countries*, provided they have
been:
a) implanted in accordance with Nagor guidelines and
instructions as per product package inserts.
b) implanted by an appropriately qualified and
licensed surgeon, in accordance with accepted
surgical procedures and techniques, and implanted by
a surgeon who is an authorised and participating
member of the
NagorEnhance® Patient Warranty
programme.
•
NagorEnhance® Patient Warranty applies only to
Nagor mammary implants implanted after the
introduction of the
NagorEnhance® programme within
the specified country, and to patients who have
correctly registered with the programme.
•
NagorEnhance® Patient Warranty will replace free
of charge, any Nagor mammary implant that is
explanted due to rupture or deflation, as a result
of loss of shell or valve integrity, without limit
in time.
•
NagorEnhance® Patient Warranty will replace free
of charge, any Nagor mammary implant that is
explanted due to severe capsular contracture#,
without limit in time.
•
NagorEnhance® Patient Warranty will, following the
surgeon’s specific recommendation, replace free of
charge the Contralateral mammary implant as a result
of a valid claim for rupture or deflation or severe
capsular contracture.
• Replacement under a valid claim will typically be
for the same Nagor mammary implant as originally
implanted, by model and size. If the same model is
not available, a suitable alternative model will be
supplied - as determined by Nagor after discussion
with the surgeon. If a size change from the original
implant is considered to be surgically necessary to
ensure breast symmetry following rupture or
deflation or severe capsular contracture, free of
charge replacement of ONE-Size either side of the
original size of implant that has been explanted
will be permitted.
Events Not Covered
• Removal of Nagor mammary implant due to patient
dissatisfaction with either the implant size or
aesthetic result.
• Adverse events other than implant deflation or
rupture.
• Adverse reaction, other than capsular contracture
(within the meaning given below).
• Loss of implant shell integrity caused by any
elective revision surgery or other surgery to the
surrounding tissue
• Loss of implant shell integrity due to open or
closed capsulotomy.
• Any Nagor saline inflatable implant which has been
inserted using endoscopic surgery techniques.
• Any Nagor saline inflatable implant which has been
exposed to intra-luminal iodine solutions.
• Custom fabricated implants.
* Note : Please check Nagor’s
international
availability page for an up-to-date listing of specified
countries and authorised offices or distributors,
plus any warranty programme amendments or revisions.
Printable versions of all required forms are
available from the download page on the Nagor web site.
# Note : Severe capsular contracture is
defined in accordance with the Baker Clinical
Grading Scale as Grades III & IV.
Important Notes
The
NagorEnhance® Patient Warranty :
• does not affect the patient’s statutory rights.
• is for the benefit of patients – it does not give
anyone else (including surgeons, hospitals etc) any
additional rights against Nagor.
• entitles the patient to claim a replacement Nagor
mammary implant free of charge – it does not extend
to any other products nor does it cover claims of
any other nature such as surgical costs. The
acceptance of a claim under the
NagorEnhance®
Patient Warranty programme does NOT constitute an
admission by Nagor that the mammary implant
concerned was, or is, defective or that Nagor has
any liability in respect of it, whether
contractually or otherwise. Any decision by Nagor to
reject a claim under the
NagorEnhance® Patient
Warranty programme is final.
Nagor reserves the right at any time in its
discretion to :
• exclude any surgeon or hospital or clinic from
participating in the
NagorEnhance® Patient Warranty
programme. If Nagor excludes a surgeon and/or
hospital or clinic from the programme, the
surgeon/hospital or clinic will be notified and
appropriate reference will be posted on the Nagor
website www.nagor.com. Surgeons or Hospitals or
Clinics who are not authorised and participating
members of the programme should not enrol patients
on it and, if they do, will be liable for all losses
and costs incurred by Nagor as a result.
• amend the terms of the programme in any way it
chooses or withdraw the programme at any time. If
the terms of the programme change or the programme
is withdrawn, Nagor will use reasonable endeavours
to notify patients by mail who have registered under
the programme, and will post details of any
programme amendments or revisions on the Nagor
website www.nagor.com. Unless Nagor expressly says
otherwise in writing, amendments to the programme
will apply to all registered patients (including
those who have already registered under the
programme) from the date that the amendment takes
effect (i.e. the date on which the amendment is
posted on Nagor's website, unless another date
is expressed to apply) but any amendments to the
terms of the programme give no retrospective rights
to patients.
Procedure
1. The Patient Registration Form is completed by the
patient (with assistance from the Surgeon, hospital
or clinic), and the patient is responsible for
sending it directly to Nagor Limited, or for
registering online, within 90 days of the date of
surgery.
2. Once registered, Nagor will issue a confirmation
letter to the patient along with a
NagorEnhance®
Patient Registration Card. The Patient Record Card
contains a unique patient reference number to enable
accurate tracking of the patient’s details whilst
maintaining patient confidentiality.
3. In the event that a patient wishes to make a
claim under the
NagorEnhance® Patient Warranty
programme, the patient should visit a surgeon for
clinical appraisal. If the surgeon considers a claim
is appropriate, the surgeon should refer to the
“Surgeon's Guidelines in the Event of a Claim”
leaflet as supplied within the
NagorEnhance® Patient
Warranty introduction folder, and should complete
the “Intention to Re-Operate” Form and forward it to
the designated Nagor office or Nagor distributor
within the specified country* without delay and
sufficiently in advance of the proposed revision
surgery date to enable review of the claim by Nagor.
4. After review of the claim, Nagor will issue
either an Authorisation or Rejection notice prior to
the proposed revision surgery date. If approved,
Nagor will issue an Authorisation number. The
replacement mammary implant will be despatched upon
receipt of an official order from the surgeon,
hospital or clinic which quotes the Authorisation
number. This will be invoiced as usual.
5. The revision surgery must take place within three
(3) months of authorisation. After the revision
surgery, the surgeon, hospital or clinic should
return the “Claim Form” PLUS the explanted and
decontaminated implant complete with the
“Declaration of Decontamination” certificate (in
accordance with Nagor’s decontamination procedures).
6. Once received and approved, in accordance with
the terms of the
NagorEnhance® Patient Warranty
programme, Nagor will raise a credit note to cover
the invoice issued against the supply of the
replacement warranty implant.
* Note : Details of the designated Nagor
office or Nagor distributor, together with any
necessary forms
can be found on the Nagor
international availability page.
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