Bart’s Corner: French Breast Implant Safety Scandal

Jun 05, 2014
Bart Cobert

Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert

There is an ongoing safety issue (read: scandal) in France regarding the use of non-medical grade silicone in breast prosthesis implants.This is a scandal that has been playing out now for about four years. There is much information available in both English and French. There is a good summary on Wikipedia.

Here’s the background:

The issue revolves around the company Poly Implant Prothese (PIP) founded in France in 1991. This company produced about 2 million breast implants over 2 decades and it is estimated that up to 400,000 women had these PIP gel breast prostheses implanted around the world – primarily in the EU and South America. They were not sold in the US but some US patients apparently did have them implanted.

It appears that in 2001 the company began using non-medical grade industrial silicone (e.g. for use in mattresses or rubber tubing) in the implants. In 2009, perhaps earlier, some reports came in from surgeons noting abnormally high rates of rupture. The French health agency ultimately received reports of some 7500 cases of rupture and 3000 cases of adverse events including inflammation. There are reports that implants were also made for male chest, testicle and buttock procedures.

This led to the removal of the products from the French and other markets in 2009/10 and the subsequent bankruptcy of PIP. An inspection of the manufacturing site in 2010 noted the use of unapproved industrial silicone which cost a fraction of the price for medical grade silicone.The head of the company was found guilty and received a four-year jail term and other executives of the company also were found guilty.

There were and are multiple issues here:

The first is lawsuits which are ongoing in various countries. However, with the company liquidated it is not clear how much (if any) money can be recouped from them. The deep pocket payers may turn out to be governments (read: taxpayers).

The next issue was (and is) to evaluate the current and potential medical problems that these implants can produce. They include rupture which can induce lumps, inflammation and irritation in the breast or axilla. Some reports suggest a rupture rate of 5-8% with the PIP implants compared to a 1% rate for other breast implants.

Several cases of breast tumors have been noted in women with these implants though it is not totally clear that the implant increased the cancer risk. There are also are reports of adenocarcinoma, lymphoma, lung cancer, AML and anaplastic large cell lymphoma.

The medical evaluations are still underway. In France it is estimated that 30,000 women are seeking removal of the implants. The French government will pay for the removals or, if the woman prefers to track the situation without surgical removal, ultrasound examinations. Questions on who would pay for new implants of acceptable prostheses after removal are also an issue. The cost is estimated at some $90 million.

In the UK and Ireland, there are 30,000-40,000 women with these implants. The issue was heavily debated for several years with particular attention to the costs of screening, treatment and new implants.

Multiple other countries are facing similar problems and the Wikipedia article noted above has a summary of the situations in many countries.

Several high level commissions and scientific advisory groups addressed the medical and toxicology issues. On May 23, 2014 the MHRA released the final EU report on the safety of these implants concluding that there is “no convincing medical, toxicological or other data to justify routine removal of intact PIP implants.” They refer to the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) final report issued in October 2013, which concluded:

  • “there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured ee breast implant from another manufacturer
  • the decision to remove an intact PIP implant should be based on an individual assessment of the woman’s condition by her surgeon or other treating physician after consultation
  • there are currently no convincing medical, toxicological or other data to justify removal of intact PIP implants”

The committee noted several points in addition to these conclusions:

  • Several cyclic siloxanes have been identified in PIP devices at higher concentrations in other silicone breast implants. Investigation of these siloxanes revealed that they are found in the bodies of women even without breast implants since they are used in many domestic products.
  • Ruptures have occurred. Some produced no symptoms. Others were associated with an inflammatory response locally or in regional lymph nodes. Neither the rupture or inflammation has been found to be associated with breast cancer or anaplastic large cell lymphoma.
  • The committee confirmed that the PIP implants do have a far higher rupture rate than implants from other manufacturers but no increased health risk has been associated with exposure to silicone gel emanating from a ruptured PIP implant compared to other implants.

So the controversy continues…

Medical screening: There is no clear, accepted screening plan. Clearly mammograms and ultrasounds are being done but it is not clear what other measures should be routinely done to pick up problems at the first sign of trouble. It is not clear how frequently they should be done.

Cost: The costs will run into hundreds of millions of dollars worldwide and the question of who pays is now heavily debated. For example, in Ireland recently, the Health Service Executive “told more than 1,500 women with breast implants that it will fund their removal on medical grounds, but will not pay for replacement implants.” See this Irish Times article.

Removal in asymptomatic women: The question of whether surgery should be done as a preventive measure on women who are having no problems at all is also unclear. Some women are opting for this with either surgery later on for a new implant from a different manufacturer or no further implants at all. There are no clear, objective criteria available to make this judgment. Again the cost of one or more surgeries is an issue. And, of course, additional surgical procedures are not without their own risk (anesthesia, infection etc.).

Adverse events over time: What is also not clear is what the duration of exposure means in terms of medical toxicity. Do the risks of problems increase the longer the implant is in place? Is there a long latency period? If the problems occur after long exposure are they greater than after short exposure (suggesting that late side effects may be worse than early ones)? Are there long term changes in the silicone itself? Most prostheses have finite “life spans” and are we approaching that in some women now?

So this report, which carefully states that it has examined the information available to date but also concludes that “there is still a need for low cost reliable tests suitable for routine use to identify implant status (leakage, rupture) in patients. It is important to improve our understanding of inter-individual differences in vulnerability to the effects of a leaking/ruptured implant since the available data indicates there are substantial variations.” See the full 90 plus page report. Although it does give some reassurance to date, there is little in it to allay fears that problems may occur in the future.

The public health bottom line: This is a public health issue where there is mass exposure, some problem but no clear cause and effect, no clear predictive mechanism for adverse events, no clear algorithm to track possible adverse events and massive costs to perform remediation which may or may not be necessary or appropriate. There is no clear path ahead and no government, health agency or physician can give rock solid advice. We must continue to watch and wait. This is a tragedy for the patients.

The pharmacovigilance/device vigilance bottom line: Do it right the first time. Don’t cheat in manufacturing, tracking, monitoring, reporting etc. When the first suspicions occur (here in 2009 perhaps earlier) solid and appropriate scientific signal work up should be done then and there given the potential magnitude of the issue. Perhaps also a little retrospective detective work is in order: Why was this manufacturing violation which led to criminal prosecution not picked up for what seems to be some 8 or 9 years. Although “watchful waiting” may be a reasonable course for some equivocal signals, it may not be so for others.

 

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