Safety of breast implants
If you are considering breast implants, you should bear in mind that breast implants always pose risks. For example, they can rupture and leak. Even though these implants are subject to the most stringent requirements, complications can always arise. For implants, there is a need to carefully consider whether the risks outweigh the benefits that you and your doctor expect.
The Inspectorate previously stated on its website that implants should be replaced after 10-15 years. However, scientifically based guidelines from plastic surgeons indicate that implants without complaints do not need to be replaced. Nevertheless, the risk of rupture and leakage from implants is known to increase after 10-15 years. No implant will last a lifetime. Therefore, they should eventually be replaced. Together with you, the surgeon should weigh the risk of the operation against the risk of leaving the implants. It is advisable to have your implants checked regularly by your practitioner.
Much research has been done on the safety of breast implants, read more about recent and ongoing investigations here. Much research has also been done on breast implants and the development of diseases. This research shows that the risks are acceptable. This means that they are not so severe that they cannot be used. When there are indications of problems with breast implants, the Inspectorate conducts an investigation with other European member states and takes measures, if necessary. See below for warnings on faulty breast implants.
A lot of attention has also been devoted to the safety of breast implants. This topic is frequently discussed in the media as well. After media attention at the end of 2016, the Netherlands Society for Plastic Surgery (NVPC) sent a letter to the Inspectorate with questions about safety. The NVPC agreed to publish this correspondence on the website of the Inspectorate. Links to this letter and the response from the Inspectorate are listed below.
How does the Inspectorate monitor?
The Dutch Health Care Inspectorate is responsible for the supervision of medical device manufacturers. The supervision of the Inspectorate isbased on legislation. Laws for this purpose include:
- Medical Devices Act
- Quality, Complaints and Disputes in Healthcare Act (Wkkgz)
- Individual Healthcare Professions Act (Wet BIG)
In addition, doctors must record how they perform certain interventions. They must also document how they meet the legal requirements. These documents are called field standards. The Inspectorate uses the field standards in the supervision.
A doctor registers the implantation of a breast implant in the national implant registry. This registry ensures that patients with breast implants can quickly be found in the event of problems.