I really couldn’t imagine having breast implants and then getting notified after awhile that I needed to have them removed! Talk about craziness! But this is exactly what is happening to several thousand women across the world who supposedly received defective breast implants.
The implants, made by a French company, Poly Implants Prothèses was closed and its products banned in April 2010 after it was revealed to have been using non-authorized, sub-standard silicone gel that caused abnormally high implant rupture rates. This inferior, industrial-grade silicone is reportedly more likely to rupture or ooze than those made from surgical silicone.
According to experts, it is more likely to break the protective layer, and then cause inflammation and other health problems, as was found in reported cases.
Apparently, anxieties over the defective implants rose sharply in November 2011 when a French woman whose implant had ruptured died from a rare cancer called anaplastic large-cell lymphoma. The French media then reported that she was the eighth woman with the PIP implants to have died of cancer, a figure for which the statistical significance is unclear.
In response to the rising concern and public attention over the implants, on December 23, 2011 the French government advised about 30,000 women to remove the possibly defective breast implants.
However, the French authorities stressed that the leaked gel carries no known link to cancer, focusing instead on how it can irritate body tissues and cause damaging inflammation.
While trying to ease the cancer fear, the French health minister, Xavier Bertrand, recommended that recipients have an “explant” procedure as a preventive, non-emergency measure, even if there were no clinical indications that the implants had been leaking substandard silicone.
Following the French announcement, approximately a half dozen other countries also followed suit.
In Brazil the National Agency for Sanitary Surveillance (ANVISA) said an estimated 12,500 Brazilian women had been fitted with French-made PIP implants and another 7,000 with Dutch-made Rofil implants, and they were also recommending removal.
“Patients with PIP or Rofil implants with rupture problems will be treated by the public (health) system, said ANVISA president Dirceu Barbano.
“The government understands that a ruptured implant implies reparatory surgery that can be done in the public system, like any reparatory surgery. If needed, the implant will be replaced,” he added.
For those women who do not have problems with the implants, the government will provide periodic checkups, ANVISA said.
The Welsh government says it will pay to replace French-made PIP breast implants for women who were treated privately. Welsh health minister Lesley Griffiths said not replacing the implants could endanger women’s health, given some have already ruptured.
In Britain, where some 40,000 women received the implants, said it was not recommending “routine removal.” “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,” the British agency said in a statement.
The healthy ministry in Venezuela, one of the region’s largest plastic surgery markets, did not comment, nor did that in Colombia, where nearly 15,000 women have had PIP implants.
No PIP implants were known to have been used in the United States, but there are concerns over an unknown number of women who traveled to South American for less-expensive implants.
To continue reading about other defective medical devices, follow this link.
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