Pre- and postoperative data

  • It is important to notice that each procedure is the interference in a body. Each person reacts differently to the surgical procedure, the healing time also depends on the organism condition and the patient’s disposition. Patient himself can significantly affect the success of the operation – with responsible approach and compliance with the doctor’s instructions. All of our clients are informed about the whole surgical procedure. Below the basic information:
  • Preoperative period
    Before the surgery you will undergo preoperative assessment, which depends as on your overall health condition as on the extent and kind of the procedure. It is very important to inform us about your health status. Please not take any pharmaceuticals or medicines without informing your doctor.
  • Surgery
    When choosing your operation date please keep in mind your proffesional duties, a planned vacation, etc. Please be aware of the fact that a few days off (with rectricted physical activity) are recommended after the surgery. Due to increesed bleeding it is important not to plan the surgery just before or during your monthly period. Also, be aware that the aftercare can be prolonged.
  • Postoperative period
    As the immediate period after the procedure we consider the first and second week. However, in the long term the period takes longer – until the scars heal. During this phase it is very important to follow the doctor’s instructions, otherwise negative effects may occur. Immediately after the surgery possible bruising and swelling appears in the operated ares, which usually dissapear in ten to fourteen days. In such a case, the patients approach and discipline can have a very positive impact on the healing time and the surgery result itself.

Information on the subject of breast implants

In connection with the affair concerning the poor quality of breast implants ISAPS and association of Czech professional societies issued an following opinions / recommendations:

Information ISAPS - PIP Implant FAQs

PIP Implant FAQs:
To all ISAPS members: the following 10 Frequently Asked Questions (FAQs) have been developed to help our members respond to patients’ questions about the PIP implant controversy. If you would like this document sent to you in another format so you can share it with your patients or post it on your website, contact the Executive Office at isaps@conmx.net We will upload it to the home page of the ISAPS website as soon as possible.

 

Isaps

1. What is wrong with the affected PIP/ROFIL implants?

The French manufacturer Poly Implant Prostheses (PIP) and the Dutch company Rofil Medical used inferior, industrial grade, silicone in the breast implants they produced and sold. These products have a higher rupture rate than other available implants. Rupture can cause inflammation from silicone leaking out into surrounding tissue.

2. Which implants are affected?

Affected products are PIP breast implants that were used since 2001. These implants were also marketed under the name M-implant by the company Rofil Medical in the Netherlands and distributed in Germany by the company Rofil Medro. Affected Rofil implants are designated as IMGHC-TX, MX-IMGHC, and IMGHC-LS. There is strong suspicion that PIP and ROFIL implants that were manufactured before 2001 are also affected and are prone to a higher rupture rate and therefore silicone leakage.

3. How do I know what brand of implants I have?

Typically, patients receive an implant ID card after such an operation which gives information about the implant, the size and the batch number. The surgeon’s name and the date of implantation should also be recorded. If you do not have such a card, we recommend that you contact the surgeon who performed the procedure to check his records and tell you.

4. How high is the risk that the implant shell can rupture and for silicone to leak out?

Recent studies by the French authorities determined a risk or rupture of up to 11.1% for PIP implants. In conventional implants, the rupture rate is up to 2%. The durability of the PIP/Rofil implants appears to be much lower than normally accepted standards.

5. What happens when silicone leaks from an implant?

Cracks in the outer shell of the implant can allow silicone to leak out and enter the body. First, the silicone passes through the lymphatic system into the lymph nodes in the armpit. From there it can move into the internal organs, which is rare. This industrial grade silicone can cause severe inflammation, irritation, and in some cases effusion. On the basis of previous studies, no increased risk of cancer was shown.

6. Do I notice when an implant ruptures?

Probably not because a crack in the implant shell can remain unnoticed, or it can lead to non-specific changes. Enlarged lymph nodes in the armpit should always be an alarm signal that leads the patient to consult with their doctor. After an accident or violent blow to the chest, you should see your doctor so he can decide if an ultrasound or magnetic resonance imaging (MRI) examination is appropriate. These tests will offer clues to determine if there is a rupture or leakage, but often provide false negative results – meaning that no silicone leaks are seen.

7. What should I do if I have a PIP or Rofil implant?

Definitely go promptly to the surgeon who operated on you for a consultation. The International Society of Aesthetic Plastic Surgeons (ISAPS) strongly supports the recommendation of the French authorities to remove the implants as a precaution, even if no symptoms or hints of rupture or leakage are present. Of course, you can decide after consulting with your doctor not to have surgery and to return instead for regular checkups. If you decide not to have the implants removed, we recommend ultrasound or MRI scans twice each year to check for ruptures.

8. Will my health insurance cover the surgery costs to remove or replace the implants? 

As an international society with members in 93 countries we cannot provide an exact answer to this question. We advise you to check with your plastic surgeon and your health insurance provider.

9. If I have my implants removed, is it possible to put new implants in at the same time?

If the implants are intact, it is always possible during the same procedure to replace them. If, however, there are complications because of the state of the implant, it may be that insertion of new implants in the same operation is not possible if rupture has been undetected for a longer period and if the industrial silicone has caused an inflammatory reaction in the surrounding tissue.

10. Do I need to look for a special surgeon?

As the implant removal may be complicated, you should always look for a board certified plastic surgeon as he will have the experience to deal with unexpected problems. The forty-one year old International Society of Aesthetic Plastic Surgery is the largest international society of individual board certified aesthetic plastic surgeons with more than 2,100 members in 93 countries. Surgeons undergo a strict application process to determine their qualifications to join the society. You will find a list of ISAPS members in your country on our website www.isaps.org
Dirk F. Richter, MD, PhD Joao C. Sampaio Goes, MD, PhD

Chair – Patient Safety Committee Chair – Communications Committee

Member, ISAPS Board of Directors ISAPS Past President

Wesseling, Germany São Paulo, Brazil

Email: dr.dirk.richter@t-online.de Email:clinica@sampaiogoes.com

Recommended by specialized companies of the Czech Republic
  • Society of Esthetic Surgery of the Czech Medical Association J. E. Purkyně
  • Society of Plastic Surgery of the Czech Medical Association J. E. Purkyně
  • Czech Oncologic Association J. E. Purkyně
  • Czech Radiologic Association J. E. Purkyně
associate themselves with the recommendation of the International Society of Aesthetic Plastic Surgery (hereinafter only „ISAPS”), given in its official statement, that irrespective of the signs of damage it recommends removal or replacement of implants from the manufacturer Poly Implant Prosthese (PIP), France and breast implants M-implants, manufactured by Rofil Medical Nederland BV, The Netherlands, in order to prevent further health risks.

Accordingly all patient with these breast implants are recommended to let those implants removed at the site of implantation. 

Your doctor decides over the urgency of this procedure.

If for whatever reason the patient is unsure over the origin of her implants, it should be verified at the site of implantation. Legal reasons demand that the health institution enters each implant used into the patient medical records and supplies this information to the patient on demand. It is also compulsory to store this information up to 40 years from hospitalization, or 5 years from ambulatory surgical procedure.

Patients of no longer existent health institutions are recommended to visit the nearest institution offering plastic surgery.

If the origin of implants remains a moot point, the only remaining possibility is to approach the local municipality office, in charge of issuing registrations to local health institutions.

If patients refuse the removal or replacement of implants legal procedures are to be followed (negative waiver), hence we recommend the following:

 

  • Patient with the reconstruction of inborn breast defects remain in standard dispensary care of plastic surgery.
  • Patient with breast reconstruction following mammary gland illness remain in standard dispensary care of oncology wards and plastic surgery wards.
  • Patients who underwent aesthetic surgery are recommended regular quarterly checks by imaging methods, mainly by ultrasound as well as an examination by plastic surgeon.

Financing

Vyjádření Ministerstva zdravotnictví ČR k úhradě nákladů na potřebnou zdravotní péči bude vydáno v nejbližší době.

Prof. MUDr. Markéta Dušková, CSc. Doc. MUDr. Miroslav Tvrdek

Association of Aesthetic Surgery of the CMS JEP Society