01/27/2012 05:59 pm ET Updated Dec 06, 2017

The PIP Affair and Trust in Health Care

There has been a great deal written recently about the now-banned silicone breast implants made by Poly Implant Prothèse (PIP), a French company which has since closed down. In 2008, French plastic surgeons reported an unusually high rate of rupture -- over five times the expected rate -- for breast implants manufactured by PIP. The high rupture rate prompted French authorities to inspect the PIP manufacturing facility. It was found that PIP substituted industrial grade silicone for medical grade silicone, which led to the closing of PIP's manufacturing facility in the spring of 2010.

Who is at risk?

Women around the world have reported the rupturing of their PIP breast implants. Although the focus of attention is on France, it is estimated that 400,000 women worldwide may have PIP breast implants, with the majority living in Brazil, Venezuela, Argentina, Britain, Germany, Spain, Italy and Australia. It appears that PIP implant stock was sold to a Dutch company and distributed as "M" implants. Patients who have had breast implant surgery in the U.S. should not be concerned for their personal safety, as PIP implants were not approved by the FDA for use in the U.S.

What are the risks?

Risks include an increased incidence of implant rupture and subsequent inflammatory reaction. The industrial grade silicone gel used by PIP has been tested and found not to be toxic. However, PIP implants have a documented high rupture rate. The released gel has been associated with a significant inflammatory reaction. This has been manifest as painful swelling in local and even remote lymph nodes. There is no statistical evidence to associate breast cancer with PIP implants.

What is the treatment?

The French society of plastic surgeons studied this problem extensively. Late last year they recommended that all PIP implants should be explanted. Subsequently, on Dec. 23, the French Ministry of Health advised the estimated 30,000 French women with PIP implants to have their implants removed prophylactically, and France has said it will bear the cost of those procedures. To date, other European health authorities have not recommended explantation while they prefer to wait for more data.

Who is responsible?

Central to this issue is how PIP breast implants were approved by regulators. Hopefully, the truth will come out of the ongoing criminal investigation into allegations that then-PIP-president Jean-Claude Mas paid German company Tüv Rheinland to speed up the review procedure and that his company used a sub-standard gel (industrial-grade silicone like that used in mattresses) and other unauthorized products.

The question at the heart of this serious issue is this: Who is ultimately responsible for permitting unsafe breast implants to be used in surgical procedures? PIP, Tüv Rheinland (an independent certification company which ultimately recommend EU certification of the implants), leaders of the countries which sanctioned their use or the physicians who performed the procedures?

All parties involved bear some level of responsibility. Consider the path of a new drug being brought to market. Company A produces the drug. It is then reviewed and tested by the appropriate regulatory bodies (the FDA in the U.S. and the European Medicines Agency in Europe). The agencies are then responsible for ensuring the drug's safety and efficacy, and Company A is responsible for providing the regulatory bodies with all necessary information so it can make an informed decision. If the drug receives agency approval, physicians trust that: 1) the agency has done its job; and 2) Company A has operated ethically. Physicians then bear the responsibility of educating themselves on the new treatment, its best use, efficacy, risks, etc., so they can determine the most appropriate candidates. In helping to expose The PIP Affair, French plastic surgeons have demonstrated their responsibility to patients through good patient follow-up and investigating complications. Patients also bear the responsibility of being aware of the treatments they agree to take, or in this case, the products they agree to have implanted.

It is important to note that the professionals ultimately using these devices/treatments do not have control over the manufacturing of the products themselves. Patients must trust their physicians, physicians must in turn trust the regulatory bodies that approve medical treatments, and those bodies must ensure that companies producing medical products are operating ethically. It is this continuum of trust that enables effective medical practice and treatment of patients.

Under Mas' "leadership," PIP apparently engaged in unscrupulous manufacturing practices. While Mas should accept responsibility, it is not his alone. Tüv Rheinland should review its certification practices, and perhaps the EU should review its approval processes for medical implants. For example, the EU does not currently require clinical trials for medical implants.

All parties, from the manufacturers to the regulators to the physicians, must be accountable and responsible; that is the only way we will prevent the recurrence of incidences such as these, and ensure the safety of all products brought to market.

For more by Michael Yaremchuk, M.D., click here.

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