Tighter medical device regulation could not have prevented the PIP breast implant scandal, according to a UK regulatory lawyer.
Regulatory processes cannot defeat a deliberate violation of the law, such as the French company PIP’s use of industrial rather than medical grade silicone, Dev Kumar of law firm Bristows commented.
Meanwhile, a Commons Health Select Committee has challenged the NHS decision to provide only PIP implant removals but not replacements, on the grounds that it forces patients to undergo an avoidable follow-up operation.
The PIP implant scandal has rocked the European medical device industry and led to calls for tighter regulatory controls and better surveillance.
This coincides with changes to the European regulatory framework for medical devices arising from other scandals, including the high failure rate of metal-on-metal hip implants.
“The House of Commons’ Health Select Committee’s report on the PIP breast implants has once again brought the medical device regulatory system to the forefront of everyone’s attention,” said Dev Kumar.
“The report, which also mentions the safety concerns of metal-on-metal hip implants, suggests that the CE mark requirements and regulatory framework are strengthened.
“The timing of the PIP case and Select Committee report are all the more relevant as they have surfaced at a time when the European Commission is drawing up proposals to revise the regulatory system for medical devices. Currently, these include plans to improve and strengthen the regulatory framework through the introduction of measures for more pre-market testing and post-marketing surveillance.
“However, the PIP case concerns a company that intentionally chose to use an industrial, as opposed to a medical grade, silicone filler. No regulatory system, however robust, can guarantee against a further incident of this nature occurring if there is deliberate intent to circumvent the law.”
The question of how the NHS should assist patients who received PIP implants from private clinics remains contentious. Current NHS policy is that such patients can have the implants removed, but not replaced, on the NHS if the clinic will not help.
However, a Commons Health Select Committee argued that to save patients from being operated on twice, the NHS should remove and replace the implants but impose a charge of about £1,500 for the latter procedure.
The DH responded by saying that requiring patients to pay for an NHS treatment would set a dangerous precedent.