“Maybe it’s shameful, but there you go. We live in a capitalist world.” This is how the lawyer for the company implicated in the current breast implant controversy in Europe explained to Reuters news the cause of the fiasco in which thousands of women received industrial grade silicone in their implants.

A Scientific Committee On Emerging And Newly Identified Health Risks (SCENIHR) was convened by the European Commission (EC) to investigate the scandal over the use of the breast implants made by Poly Implant Prothese (PIP), a French manufacturer.

The Committee was set up to create advice because, according to the EC, there is no common approach to risk management in the different European countries with some recommending preventive removal of implants and other countries opting for monitoring only.

The scandal may be widening as the Committee learned that PIP silicone breast implants were also marketed by another company under two different names.

Conclusions

SCENIHR issued its report on February 1, 2012 stating that “the limited clinical data, along with the absence of epidemiologic data on PIP [Poly Implant Prothese] silicone breast implants provide insufficient evidence to warrant a conclusion that women with PIP silicone breast implants have a greater risk to their health than women with breast implants from other manufacturers…”

The Committee continued “…when the limited available clinical information is taken together with the findings from tests of the physical and chemical properties of the shell and silicone, and of the in vivo irritancy test, some concerns are raised about the safety of PIP silicone [in] such breast implants as the possibility for health effects cannot be ruled out. In addition, the group reported no clear temporal trend of implant problems for PIP silicone breast implants.”

Magnitude of the Problem

On the basis of available data, it is estimated that approximately 400,000 PIP silicone breast implants were sold worldwide. They were widely used in the United Kingdom, France, Spain, and Germany, where respectively 40K, 30K, 10K, and 7.5K women were implanted with PIP implants. According to an investigative report by Reuters, 1,262 of the estimated 300,000 implants sold worldwide have “split open” in the past two years.

Challenges In Reviewing Data

In reaching its conclusions, the SCENIHR noted the difficulties it experienced in conducting its evaluation noting such problems as uncertainty whether PIP silicone implants were used in some women until explantation has been carried out, no reporting requirements for adverse effects due to implants and consequently unreliable incidence figures, and different PIP implants varying in composition and in expected performance characteristics making it difficult to select or find a representative type of PIP implant for study.

Concrete Findings

Some of the findings that have been reported indicated weaknesses in PIP shells not found in other commercially available implant, a positive test for irritancy indicating the potential of the implant to cause irritancy if ruptured, and case reports suggesting that PIP implants may have a higher failure rate in the first few years after implantation compared with those from other manufacturers.

Risks and Benefits Equation

In response to the question about risks and benefits of explantation, the report states “ The evidence to date, indicating a health risk for women with PIP silicone breast implants is not strong. However, there is concern regarding an increased inflammation from ruptured PIP silicone breast implants. It is not possible to make a general risk benefit statement at this time. Rather, for the time being, the risk benefit assessment needs to be based on a patient by patient basis by the esthetic surgeon, bearing in mind the time since implantation and the psychological state of the patient.”

Further Work Called For

The SCENIHR recommended further work to establish with greater certainty the type and magnitude of health risks, if they exist. In addition to further chemical and biological studies, the group recommended the creation of a reliable database on silicone breast implants and other implant failures and health effects of such failures.

Impressive Review

The 74-page report is an impressive review of available evidence on all breast implants and not just PIP implants since information about implants in general can help to assess the risk from PIP implants. According to the report, the reported frequency of local complications among breast implant recipients generally ranges from 17-36% and with additional surgery because of these complications can range from 10-30% of initial recipients. The reasons for surgery can include capsular contracture, pain, hematoma, and infection.

Findings From Epidemiology

While no epidemiologic studies of PIP implants have been carried out, epidemiologists have carried out valuable studies on breast implants in general. From these studies, clear evidence against an increased risk of breast cancer or any other type of cancer has been produced, according to the report. Also, epidemiologic investigations have provided consistent evidence against connective tissue diseases as being related to implants and against health effects in the offspring of recipients. The report notes that it is a consistent observation that the population of women with cosmetic breast implants has a 2-3 fold higher rate of suicide than similar-aged women in the general population.

In releasing the report, the EC Health and Consumers Commissioner, John Dalli said: "In the current situation, patients' health remains the priority. The opinion published today sums up the current scientific knowledge on this case…Furthermore, the Commission will discuss with the Member States a series of immediate measures to strengthen the existing surveillance and safety controls on medical devices already on the market. The capacity to detect and minimize the risk of fraud must be increased…We had already been working on a revision of the Medical Devices Directive, envisaged for adoption  this spring.  We will now also take into account the lessons learnt from this case and take them on board in redrafting our legislation, in particular with regard to market surveillance, vigilance and functioning of notified bodies."

Reuters Investigative Report

According to an exhaustive Reuters investigation, the story of the PIP implants “…is a tale of a haphazardly run and cash-strapped company that allegedly took desperate and sometimes deceptive steps to shave costs and hide the true ingredients of its devices. PIP’s efforts were made easier by a European regulatory regime that had been essentially outsourced to the very companies that are meant to be regulated.”

To read the report of the European Commission, visit:
 http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_034.pdf

To read the investigative report of the incident by Reuters, visit:
http://www.reuters.com/article/2012/02/02/us-breast-implants-mas-idUSTRE8110WY20120202