The 5 things you need to know about PIP breast implants
January 11th, 2012
We would like to preface the following remarks, by saying that patients treated at CosmeticCulture who have had breast augmentation with or without mastopexy or breast reconstruction, can be rest assured that we have never used the Poly Implant Prosthesis (PIP). Unfortunately, at the time of writing, the Therapeutic Goods Administration (TGA) has been advised that approximately 9,054 PIP breast implants have been implanted by surgeons between 2002 and 2010.
1. PIP implants are defective
The French manufacturer Poly Implant Prostheses (PIP) and the Dutch company Rofil Medical used inferior, industrial grade (instead of medical 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. 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. 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. In Australia, non-implanted silicone implants manufactured by PIP were recalled by the Therapeutics Good Administration (TGA) in April 2010 and the Breast Implant Registry (BIR) was successfully used to contact both patients with PIP implants and those surgeons registered on the BIR who used PIP implants in their surgery.
2. Potential for high risk of rupture and silicone leakage
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. This is in stark contrast to what TGA advises that, based on current rates of reporting of implant rupture to the TGA, there is no evidence of an increased rupture rate for PIP silicone gel breast implants used in Australia. The TGA has received 37 reports of rupture of PIP breast implants. This equates to a rate of 0.4% of PIP implants inserted in Australia over the past decade. This rate is well within the expected rupture rate for silicone breast implants. Long term follow up studies conducted in the USA show that rupture rates for silicone breast implants are approximately 1.0% per year. That means that for breast implants of all types approximately 10% of implants will have ruptured by 10 years after insertion.
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.
The TGA has tested PIP implants to determine the strength of the outer shell of the implant and its ability to resist rupture and determined that the PIP breast implants from the batches supplied and tested in Australia meet the relevant international standards for tensile strength. This differs from the results of testing of implants supplied in France by the French regulator AFSSAPS which showed lower tensile strength on one measure. This raises the possibility that the higher rates of rupture identified in France may relate to specific batches supplied in that country but not utilised in Australia. Importantly, the TGA and its British counterpart, the MHRA, have analysed the gel used in the PIP implants to assess whether it is toxic to cells (cytotoxicity) or likely to affect the DNA of cells (genotoxicity). This testing has demonstrated that the silicone gel utilised in the PIP implants supplied in Australia and the UK is not cytotoxic nor likely to raise the risk of cancer (genotoxic). The TGA has received no reports of the rare tumour Anaplastic Large Cell Lymphoma (ALCL) in Australian women who have received PIP implants.
3. A ruptured implant may go unnoticed
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.
4. If you have a PIP or Rofil implant, see your surgeon
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.
5. You may need to remove or replace the implants
We advise that you to check with your plastic surgeon and your health insurance provider. 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. 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.
Thanks for reading!
DrTim





