A Guide for Aesthetic Society Members with Patients Presenting with PIP Implants
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.
As the substance was industrial grade silicone, we don’t know what the impurities are and what the adverse effects of rupture may be. For this reason, removal should be recommended.
Which implants are affected? Affected products are PIP, silicone 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. These implants were never FDA approved.
Implant Brand: 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 a patient consults you about implants that were placed in one of the countries involved and does not have such a card, we recommend that your patient contact the surgeon who performed the procedure to check his/her records to help to determine the type of implant used. Countries where these implants were available include England, France, Argentina, Venezuela, Brazil, Germany or the Czech Republic.
How high is the risk that the implant shell can rupture and for silicone to leak out? Implants manufactured in the US have a rupture rate of roughly 1% / year. The durability of the PIP/Rofil implants appears to be much lower than normally accepted standards; according to French reports, the rupture rates of PIP implants is anywhere from 1-11%. A recent clinical study on the issue can be found at: http://www.ncbi.nlm.nih.gov/pubmed/16772913
Should the implants be removed? We agree with our colleagues at The International Society of Aesthetic Plastic Surgeons (ISAPS) who 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.
How can I assure patients that this isn’t happening with American Manufactured Implants? The FDA inspects all of the US manufacturers so purity is assured.
If you do see patients with PIP implants and remove them, please share your experience with our Patient Safety Organization http://wimed.org/asaps/. This is a completely safe and anonymous reporting mechanism for physicians.