It has recently come to light that the now defunct French company, Poly Implant Prosthesis, had been illegally changing the silicone gel injected into their “approved” PIP breast implants to an inferior, non-medical grade “industrial” silicone. It is thought that this has caused the implants to have a higher incidence of spontaneous rupture and the specific health implications to the women with these implants are currently unknown. These implants were only previously approved in Europe and never in the United States. It is thought that currently 30,000 French women, 40,000 British women and up to 25,000 Brazilian women have received this make of implant in the past. The total number of women could approach 300,000.
The French government recently issued an unprecedented statement recommending any woman who has received this implant to have it “explanted” or removed. It is unclear whether they will cover the cost of a secondary augmentation with a different product. This implant has possibly also been rebranded as an “M” implant and marketed in other countries – so the exact number of women suffering from this is currently unknown. It is possible that the implants have been sold in Western Europe, South America (Brazil, Chile and Argentina) and Australia.
The UK has not recommended any large-scale removal at this point. The regulatory agency was quoted as saying “We recognize the concern that some women who have these implants may be feeling, but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France.”
One of the women who suffered from a rupture has since died from anaplastic large cell lymphoma, but there is no evidence to suggest any association between the leakage and cancer development. It is being reported that there was evidence of this being an issue as early as March of 2010, but it has taken as long as 21 months for this to come to light. The parent company has admitted that two types of silicone were used in the manufacture of this product “But there’s no cause-and-effect link between it and any harm suffered by this or that person,” an attorney for PIP was quoted as saying
Women who choose to not undergo elective implant removal are currently being encourage to undergo ultrasound examinations every six months to be evaluated for evidence of rupture. The FDA has encouraged US women who possibly received these implants to report their experience through their website – https://www.accessdata.fda.gov/scripts/medwatch/
To read more about the specific issues related to the PIP breast implant controversy, click on the following links:
New York Times article: http://goo.gl/TAZEA
New Zealand Herald: http://goo.gl/c7Hoy
STL Today: http://goo.gl/U7NOA
The Guardian: http://goo.gl/M1bQb
If you have any specific concerns about your breast implants, please contact our office at 858-638-9800.
Dr. Vincent Marin
San Diego Plastic Surgeon