Question 1

What products are covered?

Accepted Answer

GC Aesthetics Silicone gel-filled breast implants.

Question 2

What brands are covered?

Accepted Answer

All GC Aesthetics breast implants (Nagor and Eurosilicone) brands.

Question 3

Are previously implanted products covered?

Accepted Answer

Yes, for Capsular Contracture and Rupture the warranty is fully retrospective and will cover all currently implanted GC Aesthetics (Nagor and Eurosilicone) gel-ﬁlled breast implants.  For BIA-ALCL the warranty is applicable only to those GCA products implanted after 1st January 2009.

Question 4

How long does the warranty last?

Accepted Answer

For the lifetime of the Patient.

Question 5

Who can submit a complaint or claim request?

Accepted Answer

Healthcare professionals. If you are a patient, we invite you to contact your registered medical physician in order to get the appropriate support.

Question 6

How can a complaint be registered?

Accepted Answer

Complaints can be registered by your Healthcare Professional by contacting us at:
Nagor products email:  ukvigilance@gcaesthetics.com
Eurosilicone products email:  return@gcaesthetics.com
Your healthcare professional can request the GC Aesthetics Customer Complaint Form for completion.

Question 7

What information is required and why?

Accepted Answer

It is our priority to give customer confidence. We, as a responsible company, follow all regulatory requirements in countries where we trade. As a minimum, the medical physician will need to provide us with: the brand, model, size, lot number and serial number of the explanted product(s), and the reason for the claim as documented in our ‘Customer Complaint Form’. We may request additional information depending on your concern in order to provide the best support.

Question 8

How long will it take to confirm whether I am eligible to claim under the GCA warranty?

Accepted Answer

It is our priority to give customer confidence. We deal with all requests as a matter of urgency, so our average response time is 72 hours from receipt of accurate information provided using the GCA ‘Customer Complaint Form’.

Question 9

What does this warranty cover?

Accepted Answer

GCA provides free of charge replacement implants in the event of rupture of one or both* implants.
GCA provides free of charge replacement implants in the event of capsular contracture (Grade III or IV only on the Baker Scale) of one or both* implants.
*Contralateral exchange is applicable if deemed necessary by your Physician.

Question 10

Which replacements are available?

Accepted Answer

Any model, size or style from our GCA brands (Nagor or Eurosilicone) of breast implants from the current catalogue.

Question 11

Does the warranty cover costs of surgery?

Accepted Answer

No, in the case of rupture or capsular contracture, the warranty applies to the product only and does not cover any costs of surgery.

Question 12

How do I claim on the warranty for rupture or capsular contracture?

Accepted Answer

Your registered medical physician should contact us at the email address provided and should complete the GCA ‘Customer Complaint Form’ and supply associated evidence. On receipt of adequate information, the complaint will be processed and we will confirm whether or not the application is successful.

Question 13

Medical referral

Accepted Answer

If you have any concerns about BIA-ACL in connection with your GCA implants you should discuss those concerns with your surgeon or qualified medical physician.

Question 14

Are there any time limitations on the warranty?

Accepted Answer

The warranty applies to all GC Aesthetics (Nagor or Eurosilicone) implant products, implanted after January 01, 2009, by an appropriately qualiﬁed and licensed Physician in accordance with accepted surgical procedures and techniques, and in strict accordance with the GCA “Instructions for Use” supplied with the product, but not where symptoms could be linked to non GCA breast implants.

Question 15

What does this BIA-ALCL Comfort Plus warranty cover?

Accepted Answer

GCA offers the following warranty when a BIA-ALCL is confirmed by a qualified medical physician and GCA demonstrates that the patient is eligible for the Comfort Plus Warranty:

- Reimbursement of up to USD $3,000 (or Euro or GBP equivalent) towards (a) the cost of necessary medical scan(s) and (b) the cost of necessary surgery to remove the breast implant(s) and associated scar tissue.
- In the event the patient experiences multiple qualified events, GCA will only make one payment up to the defined maximum mentioned above and based on submission of supporting incurred expense receipts.
- Replacement implants: GCA will replace breast implants with any model, size, or style, from the significant range of GCA breast implants currently featured in our catalogue.

Question 16

How is a claim registered by my healthcare physician?

Accepted Answer

Your healthcare professional should contact us with the required information by emailing us at:
Nagor® products email: ukvigilance@gcaesthetics.com
Eurosilicone® products email: return@gcaesthetics.com

Question 17

¿Qué productos están cubiertos?

Accepted Answer

Implantes mamarios de gel de silicona de GC Aesthetics®.

Question 18

¿Qué marcas están cubiertas?

Accepted Answer

Todas las marcas de implantes mamarios de GC Aesthetics® (Nagor® y Eurosilicone®).

Question 19

¿Están cubiertos productos implantados con anterioridad?

Accepted Answer

Sí, en caso de contractura capsular y rotura, la garantía es completamente retrospectiva y cubrirá todos los implantes mamarios de gel de GC Aesthetics® (Nagor® y Eurosilicone®) actualmente implantados. En caso de LACG-AIM la garantía solo es aplicable a los productos de GCA implantados después del 1 de enero de 2009.

Question 20

¿Cuánto tiempo dura la garantía?

Accepted Answer

Toda la vida de la paciente.

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