Importance of the implant passport
Like a vaccination certificate, the implant passport is an important document that must be issued by all physicians in Germany since October 1, 2015. It contains all relevant information about the implanted implant. In this way, the implanted medical device can traced back to the manufacturer and doctors providing further treatment have an insight into the intervention performed. An implant passport thus makes a significant contribution to patient safety.
Legal obligation for healthcare facilities
The mandatory issuance of an implant passport is specified in the Medical Devices Operator Ordinance (MPBetreibV). Under §15 “Special obligations for implantable medical devices”, it is a legal requirement that, immediately after implantation, information must be for the postoperative behavior and the required control examinations must be handed out to the patients.
Furthermore, this regulation stipulates that an implant passport must be issued, which contains at least the following data:
- Full name of the patient Serial number,
- Name, type, type / model of medical device
- Manufacturer of the implant
- Date of implantation
- Name of the person who performed the implantation
- Facility where the implantation took place
Implant recipients should keep the passport with their important documents in all cases.
It is also advisable to keep a copy of it with the responsible family doctor and with the gynecologist. Likewise, it is advisable to have this with you if an inpatient stay in a clinic is planned. Also remember to keep a copy of the Implant passport with your travel documents because it is always possible that you will need to visit a hospital even during your vacation.
Of course, the first port of call is always the healthcare facility or the doctor who inserted the implant if post-operative symptoms occur. However, it is also possible that symptoms occur that, at first glance for the layperson, are not related to the implantation. Due to the knowledge of an existing implant and the Information from the implant passport other specialists can then also react quickly and adequately in an emergency.
Implant passport for breast implants
The fact that implant passports for metallic implants are required at airport security checks, or when undergoing MRIs and some other medical examinations, is well known. But why do patients need a passport for a breast implant? The implant passport is indispensable in the case of breast implants when manufacturers issue recalls. Defective implants that could endanger the health of patients must be serially located and removed. Unfortunately, there have already been scandals involving substandard medical devices in the past.
In order to maintain high standards in Germany, health care facilities and doctors of plastic surgery generally do their utmost to work with trustworthy manufacturers of implants Dr. Martha Bernard has been running her practice for plastic and aesthetic surgery since 2008 and can thus demonstrate many years of experience with different types of implants and manufacturers. She only uses implants that have been tested over many years and have been classified as particularly safe. Long-term studies of just such implants are also a top priority for the practice.
It is therefore all the more important to have a detailed and confidential discussion before the procedure, in which questions can be asked about breast augmentation or the implant.
Advantages of the implant passport
The implant passport offers patients themselves, as well as physicians and manufacturers of medical devices, access to the relevant information on the implant used. The data in the passport (name of the institution and the surgeon, date of implantation, etc.) provide complete documentation from the patient’s preoperative information, the surgery itself, to postoperative follow-up.
This can be a very useful process in the event of complications arising and any disputes. Another advantage is that implants can be traced back to the manufacturer more quickly so that the manufacturer can then be held accountable. Patients with implanted defective medical devices can be traced more quickly and treated immediately. The implant passport is also helpful if an implant change is necessary. In principle, breast implants can remain in the body for a very long time unless there is a medical reason for a change.
Implant passports are mandatory to issue in Austria and Germany by law. The legal situation in other EU countries may of course be different. If you are considering having breast implants implanted abroad, please find out in advance exactly whether you an implant passport from the health facility from the health care facility. Remember that your health is at stake and that this medical document could save your life in case of complications such as rupture, subluxation or inflammation of the breast tissue.