Regulatory Capture and Patient Safety Failures

Failing medical implants are causing hundreds of thousands of people misery

September 20, 2017 7.09am EDT

Author

• Thomas J Joyce Professor, Newcastle University 

Disclosure statement

Thomas Joyce has received funding from EPSRC, the FDA and the BOA for his work on metal-on-metal hips. Thomas Joyce does medico-legal consultancy regarding metal-on-hip implants. All income goes to Newcastle University.

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Newcastle University provides funding as a member of The Conversation UK.

Thousands of women across the world have been left in terrible pain after being implanted with transvaginal mesh – a device to treat urinary incontinence or prolapse. How did a medical implant that has caused so much damage to these women’s bodies and lives come to be sold?

Most people probably have a good idea of how drugs are tested and approved – through clinical trials and placebos – but they probably don’t know how medical implants make it onto the market. If a headache pill that works for four hours has undergone clinical trials, what about an artificial hip that has to last for 40 years inside you?

The truth is, that for most medical implants, no clinical trials are undertaken. Instead, most medical implants are approved on the basis of “substantial equivalence”. In other words, if your new implant is substantially equivalent to an implant already on the market, then it likely gets approved.

Clearly someone has to decide how close one implant is to another. And in my experience, they can be quite different from each other and still get approved. Indeed, when independently reviewed in the US, the substantial equivalence process was said to give no evidence that “the cleared device was safe or effective”.

Three recent scandals

Many implant makers highlight the regulatory “burden” required to bring a new implant to market. However, despite these regulations, there have been three recent scandals involving medical implants: metal-on-metal hips, breast implants and mesh implants. Arguably, this shows that medical implant regulation isn’t working. At the very least, these scandals have left hundreds of thousands of people worrying about the long-term effects of defective implants in their bodies.

Many thousands of people have been left in pain, perhaps unable to work. Others have seen relationships break down and feel that their lives have been ruined.

There are many heartbreaking stories from patients who were told their lives would be changed for the better, not worse, and it seems reasonable to ask how this situation came about so that it can be prevented in future.

Why do we have these scandals?

I think there are three main factors. First, despite some companies’ claims of a primary responsibility to their patients, most companies exist to make a profit, which means bringing implants to market quickly and selling as many as possible. Why spend money on a long, expensive clinical trial when regulations say you don’t have to?

The second factor is the regulators themselves. These organisations are often guided by their government to work with industry to bring innovative medical implants to market, both to benefit manufacturers (who provide jobs and pay taxes) and patients. If the pull is too much towards industry, this is known as “regulatory capture”. This is where a regulator that has been set up to act in the public interest, instead advances the concerns of the sector it is charged with regulating.

It is also interesting to consider the word “innovative”; why do medical implants need to be innovative rather than safer or longer lasting or less expensive? Innovative means that a patent can be obtained, which can then be used to generate income. A safer implant doesn’t appear to carry the same potential financial reward as an innovative implant.

The third factor is a lack of transparency over the approval process. If the implant was approved in the EU, the information is confidential. This makes it very difficult to assess how an implant was tested and what the test results were. So the main judgement on an implant’s performance will come only after implantation – maybe two, five, even ten years down the line. To me, if the implant is deficient, that’s too late. By that time, thousands of people will have been implanted with a substandard device.

How to fix it

Of course, there are ways to make the system work better. For example, there could be phased introduction of new medical implants undertaken at specialist centres where all details of the implants and the procedures are fully tracked. Once the efficacy is shown after a certain amount of time, then the implant could be introduced more widely.

It is also important that regulatory capture is acknowledged. The priority for regulators should be stated as patient safety. If that means regulators stopping medical devices being implanted while patient concerns are investigated, then so be it.

Finally, transparency needs to be improved. We need to know what tests were done on implants and what the results were. With these changes in place, we might make implant scandals a thing of the past, not ongoing news.

Gender targeting by (sometimes criminal) medical device industry? Breast implants, birth control, transvaginal surgical mesh?

Maker of faulty French breast implants given fouryears in jail

BY JEAN-FRANCOIS ROSNOBLET AND ALEXANDRIA SAGE

MARSEILLE/PARIS Tue Dec 10, 2013 8:00am EST Reuters FiDA highlight

(Reuters) - The founder of a French breast implant company was sentenced to four years in prison on Tuesday for hiding the true nature of the sub-standard silicone used in implants sold to 300,000 women around the world.

Jean-Claude Mas, 74, founder and long-time chief executive of Poly Implant Prothese (PIP), was prosecuted after a worldwide panic in 2011 when France recommended that women with such implants should have them removed due to an abnormally high rupture rate.

Worries about the implants launched a flurry of international lawsuits and prompted calls for Europe to toughen controls on medical devices and fix its fractured oversight system.

Once the third-largest global supplier of breast implants, the company was shut in 2010 and its implants ordered off the market after inspectors pursuing a tip-off discovered vats of industrial-grade silicone outside the PIP factory in the southern town of La-Seyne-sur-Mer.

A Marseille criminal court also ordered Mas, who had been pursued for aggravated fraud, to pay a 75,000-euro ($103,000) fine. His lawyer, Yves Haddad, said he would appeal.

Four other executives, including the chief financial officer, were sentenced to between one-and-a-half and three years in prison, some of it suspended, and fined.

"It's a strong signal. This decision is what victims were waiting for," said one of their lawyers, Philippe Courtois.

The president of a PIP victims group, Alexandra Blachere, called it a "symbolic sentence" that challenged any prejudice that there was "a ditzy bimbo behind every pair of silicone breasts."

The two-month trial in April and May was held in an exhibition center to accommodate the 7,400 civil plaintiffs and 300 lawyers. Jeers from the crowd greeted Mas' appearance in the makeshift courtroom.

For less serious felonies in France, the criminal court hands down a sentence without pronouncing a guilty or not guilty verdict, which is implicit.

HIDDEN EVIDENCE

Mas admitted using silicone created by trial and error that was never approved by regulators and which cost a seventh of the price of silicone approved for use in medical devices.

He has insisted the gel he had relied on since the founding of the company in 1991 was non-toxic and has said women who complain about their PIP implants are "fragile people, or people who are doing it for the money."

A police investigation revealed a sophisticated fraud at PIP, which managed to conceal the implants' ingredients from regulators, thereby allowing them to be sold on international markets.

Before annual audits to the PIP factory by private certification company TUV Rheinland, employees would clear away evidence of the cheaper gel it used to fill implants.

For a special report on the PIP scandal, click here:

TUV sued PIP for fraud, but a French court ruled last month the German company had failed in its obligations of "vigilance and caution" and ordered it to pay 3,000 euros to each of the 1,600 plaintiffs, women wearing PIP implants who had sued.

Health experts insist that no link has been established between PIP implants and breast cancer.

Still, women around the world with PIP implants, whether in Venezuela, France or Britain, have rushed to their surgeons to have them removed, fearing health complications.

Since France recommended removal, some 14,729 women in France - nearly half of all French women with PIP implants - have chosen this option, according to French regulators.

Regulators say a quarter of PIP implants removed were found to be faulty, most having ruptured.

Only one case of anaplastic large cell lymphoma, a rare type of cancer originating in the lymphatic system, has been documented in France from a women wearing PIP implants.

National health agencies have given differing advice. While France and Venezuela offered to reimburse women who have their PIP implants removed, other countries, such as Britain, recommended that women merely have them checked.

Other legal cases related to PIP are still pending in France, including one related to the 2010 death of a woman wearing PIP implants. Another relates to tax fraud by Mas, his former girlfriend and Chief Executive Claude Couty.

(Writing By Alexandria Sage; Editing by Mark John and Ruth Pitchford)