France is the first country to place a ban on a new breast implant linked to cancer. The ban is on several breast implant models produced by six companies. A rare type of cancer that attacks the body’s immune system has been linked to these breast implants. Out of 400,000 women with breast implants in France, 70,000 are likely to have the banned implants.
France went for the ban as a precautionary measure due to the ‘rare though serious’ implications these implants pose. The national agency reported cancer in 59 women using breast implants and 3 out of the 59 had died. The agency added that the more the implant was rough and textured the more it was risky due to anaplastic large-cell lymphoma (ALCL).
No scientific knowledge of the ALCL presence in the implants can be offered. Due to the rarity of risk, the agency discourages the implant wearers from undergoing surgery to get them out. On Thursday 4th April 2019, Canada announced that it was in the process of suspending the same implant. Canada attributed this action to the rise in the number of ALCL triggered cases following a routine safety review.
The agency has recorded 28 cases in Canada out of the 457 ALCL cases in implant wearers worldwide. These figures were compiled by the US Food and Drug Administration.
History and Founder
Patient stories can bring positive or negative change in the healthcare industry. PIP- Poly Implant Prothese Company was a victim of such when a breast implant scandal broke out: cutting-cost decisions led to substandard products and eventually caused injuries that forced key regulatory updates.
A plastic surgeon Henri Arion, in 1965 introduced breast implants to France. A former butcher Jean-Claude Mas turned into a salesperson and together until Henri died in a plane crash and Mas went ahead and launched PIP in 1991.
That was the birth of the company that would produce over 2 million breast implant sets in 20 years and land a global market share and maps medical device regulations. The PIP scandal emerged when they produced implants made of low-grade silicon not medically proven for use. This was discovered when the implants kept rupturing double above the industrial rate. The company was forced to withdraw the hydrogel implants.
In 2000 PIP fell in trouble for saline-filled implants for deviating from producing standard implants and was unable to prove safety. Over the years PIP has undergone policy violation and scrutiny issues and lost huge finances in regulatory filings.
As a result, European Commission started a regulatory journey into medical devices with an aim to provide high-level devices, guarantee safety and restore public confidence. The compliance regulations were tightened to enhance patient safety.
PIP founder Jean-Claude Mas died at the age of 79. He had made a run for a long time and somewhat managed to stay afloat. However, in 2013 he was sentenced to 4 years imprisonment for fraud.
PIP had exported 80% of the manufactured implants before the plant shut down. This scandal has affected approximately 300,000 women in over 65 countries including France, Canada, Venezuela, Germany, and Brazil.
PIP scandal is a clear indication of when the system fails the patients, it also triggered some major reforms in the medical device regulations in the European Union. While the full extent and damage are still not clear, the effort employed in trying to strengthen the system and rules is a step in the right direction towards safeguarding and protecting patients.
Apart from the lessons, history indicates that human subject safety is still a concern. Otherwise, the number of affected patients wouldn’t have been so high and widespread if a thorough clinical trial had been conducted.
Before an implant enters the market, the manufacture should answer and show proof of their answer to this question: what have you done to ensure the subject/patient is protected?
Brentnall, Adam R., et al. “Long-Term Accuracy of Breast Cancer Risk Assessment Combining Classic Risk Factors and Breast Density.” JAMA Oncology, vol. 4, no. 9, 2018.
Cust, Anne E., et al. “Assessing the Incremental Contribution of Common Genomic Variants to Melanoma Risk Prediction in Two Population-Based Studies.” Journal of Investigative Dermatology, vol. 138, no. 12, 2018, pp. 2617–2624.