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Should health-care facilities destroy the PIP implants still in stock? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Afssaps has not requested the destruction of these products. However, the terms of the decision imply the products should not be used as long as the suspension decision is in effect. Neither the scheduled analyses nor the legal procedure in progress …

How are the complications following the rupture of a PIP implant covered? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Regarding the coverage of complications due to silicone gel leakage from a breast implant, Social Security indicates that if it has not covered the initial breast implant surgery (in the case of aesthetic surgery), it will only cover, the medical …

What kind of tests are performed on the PIP company implants and when will the results be disclosed? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Three types of analyses are being performed on the PIP implants:

  • characterisation of different silicone gel used,
  • evaluation of implants properties as well as used gel properties in order to characterise the implants resistance and particularly the …

According to Afssaps what should be done with the removed implants? Date: 15. June 2021 Topics: Medical devices Type: FAQ

What should be done with removed implants is up to the patient. Laboratory controls currently in progress do not require the gathering of removed implants. They are performed on prostheses taken from different stocks.

What long-term medical follow-up should I have? Date: 15. June 2021 Topics: Medical devices Type: FAQ

You must follow the usual recommended follow-up and have an ultrasound performed every year.

Who should I contact to get further information? Date: 15. June 2021 Topics: Medical devices Type: FAQ

First, you should contact your surgeon or your doctor. A free number (0800 636 636) has also been set up at Afssaps.

If they are removed, can they be replaced? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Usually, the insertion of new implants is possible. Your surgeon will explain the conditions.

Should I have my breast implants removed? Date: 15. June 2021 Topics: Medical devices Type: FAQ

To date, according to experts, nothing justifies a preventive replacement of the implant under which the surgery may be considered.

What are the symptoms of an implant rupture? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Most of the time implants rupture without any symptom. An implant rupture can be detected during a clinical examination. The health professional will prescribe additional examinations if necessary. For this reason it is important to regularly keep up …

Are these risks potentially serious? Date: 15. June 2021 Topics: Medical devices Type: FAQ

No, but a ruptured breast implant should be replaced. This recommendation applies to any type of breast implant.

What are the risks for my health? Date: 15. June 2021 Topics: Medical devices Type: FAQ

At this point no complications different from those usually encountered with other breast implants have been identified.
However, a higher frequency of rupture of these implants and local inflammatory reactions have been observed.

What should I do if I have one of these implants? Date: 15. June 2021 Topics: Medical devices Type: FAQ

You should make an appointment with your doctor or surgeon in order to be examined so that he/she can prescribe an appropriate examination if necessary.
We remind you that in any case, a follow-up is set up for all women with breast implants.

What if I cannot find the surgeon who performed my surgical operation? Date: 15. June 2021 Topics: Medical devices Type: FAQ

The health-care facility where you were treated has this information. It will be easier to find your medical records if you can provide information such as date of surgery, name of surgeon, etc.

How can I find out if my implant is involved? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Information about the type of breast implant inserted is available in the handbook (operative record, implant card) provided by the surgeon after your operation. In case you don’t have this information, we recommend you contact the surgeon who …

What is the problem with these implants? Date: 15. June 2021 Topics: Medical devices Type: FAQ

Afssaps decided to carry out an inspection on the premises of PIP Company after vigilance reports revealed an increase in the number of declaration of implant ruptures The elements collected during this inspection showed that the implants were filled …

Which breast implants are involved with the decision? Date: 15. June 2021 Topics: Medical devices Type: FAQ

The breast implants concerned are implants pre-filled with silicone gel manufactured by the company Poly Implant Prothèse (PIP). Afssaps decided to suspend the marketing and use of such breast implants as well as to withdraw the products from the …

Urgent Field Safety Notice for ZytoChem-Plus HRP Kit, Broad Spectrum by Zytomed Systems GmbH PDF, 100KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 10637/21

Urgent Field Safety Notice for BESA Research 7.1 September 2020 by BESA GmbH PDF, 178KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 10941/21

Urgent Field Safety Notice for Centricity High Acuity Critical Care by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 211KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 11343/21

Urgent Field Safety Notice for Affinity IV Birthing Bed by Hill-Rom Company, Inc. PDF, 502KB, File does not meet accessibility standards Date: 15. June 2021 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 10484/21