Certifications

ISD has a unique manufacturing process that complies with all international standards of Good Manufacturing Practices (GMP) as well as International Production Certifications (ISO) in addition to regular audits from International Regulatory Agencies.

  • INTERNATIONAL CERTIFICATE OF GOOD MANUFACTURING PRACTICES – GMP
  • CERTIFICATE ISO 13485
  • CERTIFICATE ISO 9001
  • CERTIFICATE ISO 14001

Limited Warranty

Our commitment does not end with surgery. For this reason, ISD extends support to surgeons and patients before, during and after surgery because the implanted patient long term well being is our ultimate goal. ISD offers a limited warranty for all its implants which demonstrates confidence in our products and safety to surgeons and patients regarding  the choice of our implants.

Once implanted Mammary implant lifespan is 10 to 20 years according to the International Standard ISO 14607/2007/2011. After 10 years it is recommended that the patients be examined by a plastic surgeon every 1 to 2 years.

Warranty for Manufacturing Defects: ISD Mammary Implants have a 10 years warranty for manufacturing defects according to the International Standard ISO 14607/2007/2011.

Warranty for Post Surgical Contracture: ISD micro-texturized Mammary Implants have a 5 year warranty for contracture or encapsulation which applies to grades 3, 4 and 5 only.

In case of any claim the plastic surgeon or patient must submit:

  • ISD formulary completely filled out and signed by the plastic surgeon.
  • X Rays, Sonograms or Mammogram images for ISD approval before replacement surgery.
  • Limited Warranty valid only in countries where there is an authorized ISD representative.