Poly Implant Prothèse (PIP), a French medical devices manufacturer produced breast implants from 1991 to 2011. The company utilized silicone in its implants. In 2000 the US FDA launched a moratorium on silicone implants. Some reports indicate that PIP introduced the use of industrial-grade silicone in 2001 in some of their products rather than approved medical-grade silicone. Other sources say that the change in grade of implant may have occurred as early as 1997.
French surgeons began reporting a significant increase in the rupture rate of the implants in 2009. This led to legal action against PIP and ultimately the company went bankrupt.
In December 2011, following the death of a female patient in France from Anaplastic Large-Cell Lymphoma (ALCL), which has an increased incidence in women with silicone breast implants, the French government recommended that the PIP implants with the industrial-grade silicone be removed from 30,000 women in France.
The company also made male chest, testicle and buttock implants. The majority of these implants were exported to Latin America.
In the United Kingdom, it is estimated that 47,000 British women have received PIP breast implants. The Medicines and Healthcare products Regulatory Agency (MHRA), which is England's agency responsible for enhancing and safeguarding the health of the public by ensuring that medicines and medical devices work and are acceptably safe, advises that there is no evidence to recommend routine removal of the implants. Nevertheless, there is concern amongst women who have the PIP breast implants, plastic surgeons and other physicians. The National Health Service (NHS) has stated that the private firms that placed the implants would remove them without charge. The NHS also said that any woman who is not given help by a private facility could visit their General Practitioner and have access to NHS services.
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