The European Commission has released the text of a long-awaited follow-up opinion regarding the safety of breast implants manufactured by the now-defunct Poly Implant Prothese (PIP), a French manufacturer whose products ignited a firestorm of controversy over the safety of medical devices in the EU after they were found to have been manufactured to deficient standards.

Background

The PIP scandal erupted in late 2011, when regulators determined that the company had been using unapproved industrial-grade silicone to manufacture its products instead of medical grade silicone, and selling that version without having first obtained regulatory approval.

In the aftermath of the crisis, regulators around the globe scrambled to determine what, if any, risks patients implanted with the devices might face. Some were concerned about higher-than-expected reports of the devices rupturing and requiring surgical revision, while others were concerned that the silicone within the device could result in toxicities in the body.

Ultimately, most of those concerns seemed to be unwarranted. Australia's Therapeutic Goods Administration (TGA), for example, said there was "no evidence of an increased rupture rate for PIP Poly Implant Prothese silicone gel breast implants used in Australia." The UK's Medicines and Healthcare product Regulatory Agency (MHRA) said it would not-unlike Sweden-recommend getting the implants removed as a precautionary measure. And the UK's Department of Health (DOH) subsequently cleared the implants of most serious concerns, saying it found no indications that they would adversely affect long-term human health.

SCENIHR Preliminary Report

But one report remained outstanding and inconclusive, that of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) of the European Commission (EC).

In a February 2012 preliminary report, it said that the data made available to its investigators combined with the variability of product quality necessitated further study.

The investigators had two primary concerns regarding data integrity. First, the investigators were concerned that the total number of patients who have received the implants "is unknown due to patient tourism and poor record keeping by the manufacturers." Second, reporting of implant failure is optional in most jurisdictions, and data available to SCENIHR did not necessarily capture the full scope of adverse events.

However, the study found "no indication from the available data that the group of women who have had PIP silicone breast implants differ significantly from the group having implants from other manufacturers," but was unable to say if this finding was conclusive in light of their concerns.

Updated SCENIHR Report

Now SCENIHR is out with a follow-up report for public consultation, raising some new concerns but largely clearing the implants of any major safety concerns.

The report notes that since its initial findings were published in February 2012, research showed that several chemicals (cyclic siloxanes D4, D5 and D6) were present in the implants at higher concentrations than previously believed. However, subsequent analysis determined that the chemicals are non-toxic, do not cause irritation and are "commonly present in the bodies of women even without breast implants."

The report also clears the implants-even ones that have ruptured-of its most major health concerns, those related to cancer. Some had worried that ruptured implants could cause breast cancer or anaplastic large cell lymphoma. "There is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer," SCENIHR's report states.

However, the report does note a "widespread concern" about undetected ruptures, and said women implanted with the devices will need to seek out regular clinical examinations, and that removal may be warranted for those experiencing anxiety over the possibility of premature rupture. However, the committee did not recommend widespread precautionary removals, as Swedish regulators had.

The deadline for comments on the report is 3 January 2014.

SCENIHR Report

Press Statement