U.S. women are being warned about faulty French-manufactured breast implants. The now-defunct French company, Poly Implant Prothese (PIP), manufactured the defective silicone implants.
Dr. Phillip Craft, with the Miami Institute, told CBS Local that breast implants approved in the United States have “a thick exterior and medical grade silicone inside. The PIP implant has a thin exterior and industrial grade silicone inside.” Craft explained that although the implants are illegal in the U.S., about 300,000 have been sold worldwide.
The Miami Institute is holding educational seminars to inform people that PIP implants are no longer used and that the manufacturer is now bankrupt, said CBS Local. The group said it will work with patients implanted with the defective devices and is offering discounted rates for implant repair. If the implant ruptures, said CBS Local, patients can suffer from Lupus or rheumatoid arthritis, among other adverse reactions.
We recently wrote that regulators in the Netherlands advised women to have the PIP silicone breast implants removed. “ Also, the Icelandic government said it will bear the cost of patient monitoring for women with the implants, as well as implant removal for patients whose devices are damaged. “If it is torn, the implant must be removed. Even if there is no tear shown… it is recommended that the implant be removed,” the countries’ health regulator and the Dutch Association of Plastic Surgeons said in a joint statement.
In Iceland, ICENEWS reported that all women with PIP implants will be called in for a medical examination in the near future and any implants that appear damaged will be safely removed at the cost of the state; however, Iceland will not pay to have implants removed if they are not damaged, but they will be monitored.
PIP silicone breast implants were recalled in 2010 after it was learned that they contained industrial, rather than medical grade, silicone. Late last year, the same breast implants sparked cancer fears in France after one woman with ruptured implants died from aplastic large cell lymphoma (ALCL), a rare cancer. French health authorities have advised some 30,000 women there who had received the PIP silicone implants to have them removed because of their risk of rupture, but have been unable to definitively link them to cancer. The government there has said it will pay for removal procedures for women who received the implants as part of breast reconstruction surgery.
Fears about ruptures and cancer have spread to many of the other countries where the PIP devices were sold, including Brazil, Argentina, Britain, Germany, Spain, Italy, and Israel. Germany has advised women to have the devices removed, and women in several countries, including France, Iceland, Britain, and Argentina, have filed, or are planning to file, lawsuits over the implants.
The PIP silicone breast implants were never approved for sale in the U.S.; however, PIP did sell roughly 35,000 saline filled implants in the U.S. between 1996 and 2000. Those devices are the subject of U.S. product liability lawsuits alleging they deflated after several years. The U.S. Food & Drug Administration (FDA) also cited the saline implants in a warning letter in 2000, before they were taken off the market here.