Faulty Breast Implants - a Failure of the Regulatory System

The current use and hype about breast implants took a nose dive in the past few months given the scandal and upcoming class action law suit against the French company known as Poly Implant Prothese (PIP) who manufactures the silicone based gel breast implants. Reports from a recent study by a British health firm showed that a large number of these implants had ruptured in women who had them implanted.

To make matters worse an audit and inspection of the company's manufacturing process revealed that the breast implants were made using an industrial and not medical grade liquid silicone. This caused a huge scare as it was also shown that the liquid silicone leached out and may have some potential cancer causing effect. With over 500,000 women in Europe, mainly in England and France, having had cosmetic surgery to have the breast implants inserted, the outcry from the public and media was massive and caused the arrest and immediate investigation into the conduct of the French born inventor of the product and CEO of the company Jean-Claude Mas.

This raises many questions into the safety of medical devices and products that are being used and being surgically implanted into our bodies. The case of the PIP breast implants, revealed massive corruption of safety inspectors who visited the company and flaws in the medical approval process of the product by the regulating bodies. These concerns reduce the confidence of the public in their governments and regulatory offices as they continually fail to oversee and safeguard the consumer by maintaining the production of safe and standard products.

In the medical community, doctors and policy makers are foreseeing a sharp decline in the use of internal medical devices given the rising number of failing devices that is a cause of concern. For sure, the rate of breast implants uptake will reduce but the overall effect on other invasive devices, such as intrauterine and cardio, is yet to be seen and felt worldwide. This again may be due to the faith consumers and the general public have in American based companies were more stringent policies and regulations are maintained by the Food and Drug Administration (FDA) and a high rate of investigation and prosecution by house senate committee on health matters and the Attorney General's office. However, the truth of the matter is, even with such a case study, the demand of such products is on an upward trend and people tend to easily forget the events of the not so far past.

The drive by industrialist and investors will see the quick settlement of such cases and a media blackout on previous events. So in the near future, when such an occurrence occurs again, many will raise up to protest but in the end only one or two organization really care and follow up on such cases to safeguard the rights and benefits of the public and consumers of such products.