NVPC’s response to RADAR
For the broadcast of Monday, Dec. 12, 2022, the TV program RADAR asked the NVPC a number of questions about until the safety of breast implants. The NVPC would like to emphasize that the Society of Plastic Surgeons has been working for many years to improve information about and safety of breast prostheses (surgery). We do this with research, guidelines, the DBIR implant registry, honest and science-based patient information in the consultation room, the so-called surgical package insert and through the NVPC website. In doing so, women are also emphatically made aware of possible risks and alternatives are discussed.
Both the U.S. FDA, as well as the RIVM and the IGJ, with current knowledge, still view (silicone) breast prostheses as safe medical devices. The NVPC emphasizes again that women who experience complaints from their breast prosthesis(s) can always contact their plastic surgeon with questions or a consultation. The association has also been pushing for reimbursement by health insurance companies for the removal (explantation) of breast implants in cases such as BIA-ALCL or persistent physical complaints for which no other cause can be found. Furthermore, the NVPC is pushing for reimbursement from basic insurance for breast reconstructions with lipofilling through scientific research, so that an additional alternative to breast prostheses will be available for women who desire reconstruction. In conclusion, the well-being and health of our patients is at the heart of everything we do.
Below is NVPC’s response to questions from RADAR:
1. Does the NVPC acknowledge that the safety of silicone breast implants has never been conclusively proven?
Balancing the risks in medicine is always about whether they are proportionate to the benefits of a medical intervention. In addition, the magnitude of the risks plays a role in determining whether or not an intervention or implant is considered safe. Using these principles, the FDA, as well as the RIVM and the IGJ, consider (silicone) breast prostheses to be safe medical devices with current knowledge. Of course, however, it is imperative that anyone considering breast prostheses receive good, science-based information in advance about both the advantages and disadvantages of breast prostheses, including the real possibility of reoperations in the future due to problems, as also clearly articulated in our breast prosthesis surgery guideline.
2. How does the NVPC view the subpoena against Allergan by Bureau Clara Wichmann?
The NVPC has no problem with the subpoena against Allergan by Bureau Clara Wichmann.
3. Does the NVPC believe that Allergan should pay damages to women who received these textured implants?
It is up to the judiciary to rule on this.
4. How do plastic surgeons view their own responsibility in this matter?
It is not clear exactly what you are referring to, but it is very important that continued research be done on the safety of breast prostheses. For many years, the NVPC has made demonstrable efforts to improve information about and safety of breast prostheses (surgery) and good, honest, science-based patient information, the development of surgical package inserts, the development of the evidence-based guideline for breast prosthesis surgery, the establishment of the first breast prosthesis quality registry DBIR, and the promotion of breast prosthesis safety research.
Regarding Allergan: as soon as NVPC had the knowledge that there might be a link between breast implants and the risk of BIA-ALCL, NVPC included it in its patient education and brought it to the attention of the Inspectorate (IGJ), the media and its members (in December 2016).
5. What does the NVPC think of the “guarantee scheme” as offered by plastic surgeons whereby women must forcefully release Allergan from all liability?
The NVPC is not aware of this, but distances itself from it and strongly disapproves – if this course of action is true.
SOURCE: NVPC
