Massive Fraud Uncovered

The scandal began in earnest in 2010 when the French Agency for the Safety of Health Products (AFSSAPS) discovered that, since at least 2001, the French company Poly Implant Prosthese (PIP) had been using a non-medical grade of silicone in their breast implants. France revoked PIP's license to sell implants in the European Union and recommended a recall of all PIP silicone breast implants. The company soon closed down.

The 300,000 to 400,000 women in Europe, South America, and Australia who bought the low-quality silicone implants helped make PIP one of the biggest manufactures of breast implants in the world. PIP achieved this feat by using an industrial-grade silicone, normally used in mattresses, to manufacture and sell implants at a fraction of the cost as other breast implant makers.

Reports of Leaks and Ruptures

Complaints from doctors and patients began to rise in 2006 that PIP implants ruptured at unacceptable rates. Later, there would be reports that some women who had PIP implants rupture had gotten cancer, though no link between the silicone PIP used and cancer has ever been shown in tests.

The scandal reached a fever pitch in December of 2011 after the reported number of PIP implant ruptures rose again. The French government recommended that all 30,000 French women who had received PIP silicone implants have them removed. However, England’s Chief Medical Officer Dame Sally Davies advised women to seek implant removal only with evidence of a leak or rupture.

Governments Responses

The French supervisory agency in charge of medical products, AFSSAPS, released a report in December of 2010. The report found:

  1. PIP implants did not cause cancer.
  2. The implants failed one of four durability tests.
  3. 3.      They ruptured at above average rates.
  4. The silicone could cause irritation and inflammation after rupturing or leaking.

The English National Health Service released a report in 2011 supporting the opinion that PIP implants, while made of a non-approved silicone and sold fraudulently, did not necessarily post health risks; the report determined that there wasn’t enough evidence to conclude whether they ruptured more frequently than implants from other manufacturers.

Australia's Therapeutic Goods Administration (TGA) released its own report in 2010. The Australian report agreed that the cheap silicone PIP implants could cause irritation or inflammation but not cancer. Unlike the French report, the TGA reported that PIP implants passed all durability tests and did not rupture at particularly high rates.

Despite the uncertainty, many countries are offering to pay or help pay for women to have PIP silicone implants removed. If you have or think you might have PIP implants and are concerned about the health risks, talk to your doctor about removal possibilities.

Poly Implant Prosthese in the United States.

PIP silicone implants were never sold in the United States, due in part to a 14 year moratorium, with few exceptions, that the FDA put on silicone breast implants. Even when that was lifted in 2006, the FDA did not approve PIP breast implants to be sold. However, between 1996 and 2000, PIP sold saline implants in the U.S. At that point, FDA declared that even the saline implants were subpar, and should not be sold.

Plastic surgeons were temporarily authorized to continue using PIP saline implants for “compassionate use”. If, for example, a patient had a PIP implant rupture, then a doctor could replace it with another PIP implant to maintain symmetry between the patient's breasts. Due to the steep decline in reported incidents related to PIP implants, the FDA now believes that there are no more PIP implants on the U.S. market.