I recently came across the 2019 recall of Allergan's BIOCELL textured breast implants. The FDA requested this recall after data linked these implants to a rare cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Out of 573 reported cases worldwide, 481 were associated with Allergan implants, and among the 33 reported deaths, 12 of the 13 patients for whom the manufacturer was known had Allergan implants. This situation highlights failures in Quality Management and Risk Management within project management. Despite earlier concerns, it seems there was a delay in recognizing and acting upon the risks associated with these implants.
I think the solution is for companies to implement stronger risk management protocols during the design and development phases, not just rely on regulatory approvals. This includes performing more extensive hazard analysis, conducting long-term material compatibility studies, and incorporating independent expert reviews before scaling production. In terms of quality management, adopting a more proactive approach, like simulated-use testing and stress testing beyond baseline regulatory requirements, could help identify potential issues earlier. It’s also important that cross-functional teams (engineering, clinical, regulatory, QA) are aligned from the start, so emerging concerns are escalated and addressed promptly.
What do you all think? How else can quality and risk failures like this be prevented before reaching patients? Do you know of any similar examples?
I think it is very important to bring up these past situations so the future generations can continue to learn to avoid such disasters. In medical device development, safety to the patients are of most importance and it is one of the major guidelines in medical device product development.
I agree with the previous post that risk management protocols are key to prevent such instances from happening. It seems the team members did not enact some of these strategies that are mentioned in the previous post. Quality and risk failures can be prevented before reaching patients is to give a safe environment for project team members the ability to speak their concerns safely. Some people on the team may know potential hazards in the product cycle or the product itself, but may feel scrutinized if they speak up. Their concerns would cause increase costs and maybe some delays, but it should be reported anyway to ensure the safety of patients. It also ties into the ethics of the team members. They could ask themselves if they would feel safe using this on someone they know. That way it prevents the team members from being disconnected from their users.
The DePuy Articular Surface Replacement hip implant is a similar example. It was introduced by Johnson and Johnson where the hip joint contact was metal on metal. The problem was that over time through use, the metal on metal contact made the material wear out leading to metallic ion release. This could be very cytotoxic since it lead to inflammatory symptoms and tissue damage. It seems the primary reason that this was not caught before the product made it to the market was because the lack of comprehensive testing.
I agree that regulatory approval shouldn't be the end all be all for safety. There are multiple strategies that companies can and should take before a product hits the market. One such method is a Failure Modes and Effect Analysis, or FMEA. It's a structured approach use during the design phase to predict where and how a device might fail. For example, FMEA could have helped the team evaluate the long term risk of the textured interacting with tissue, which would trigger further testing or design changes before release. Another method is accelerated again and simulated use testing, where testing is done by trying to mimic what happens to a device in real-world conditions over time. Especially for implants or long-term devices, testing on how material perform under physiological conditions can bring problems that would otherwise take years to show up to light.
One example I found was Essure permanent birth control device. Approved by the FDA in 2002, Essure was marketed as a non-surgical sterilization option. However, over time thousands of women reported severe symptoms which included chronic pain, device migration and unintended pregnancies. This led to scrutinization of the product, and ultimately cease of sales of Essure in the U.S. by late 2018.
What types of pre-market tests should be mandatory for high-risk or devices implanted in the body?
Additional risk management and precautionary measures need to be taken.
I think below steps can help to prevent quality and risk failures.
1) ISO 14971 Medical device: management is a process of identifying, analysing, controlling, and preventing failures that can have dangerous consequences in the usage of medical devices.
2) Human factors engineering: Human factors/usability engineering is used to design the user-device interface. The user interface includes all components with which users interact while preparing the device for use (e.g., unpacking, set up, calibration), using the device, or performing maintenance (e.g., cleaning, replacing a battery, making repairs).
3) More robust biocompatibility and material science collaboration: Biocompatibility testing is a pivotal element within the medical device development and regulatory approval processes, ensuring their safety and compatibility when interacting with biological systems. Central to this testing are the “Big Three” assessments, namely, cytotoxicity, irritation, and sensitisation testing, which must be performed for almost all medical devices being introduced to the market.
4) Application of failure mode and effect analysis: FMEA is an analytical tool used in engineering for decades to reduce hazard. It identify failure modes, assess risk and prirotize and act. Healthcare industry can be improved by learning from experiences and techniques of other safety crtical industries
5) Corrective and preventive action (CAPA): Corrective actions are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, as well as adverse or unstable trends in product and process monitoring. FDA code 21 CFR 820.100, medical device companies need to abide by CAPA. In 2015 there were over 450 issues found with the CAPA systems for medical device companies. To have an FDA-compliant QMS system required the ability to capture, review, approve, control, and retrieve closed-loop processes.
These will reduce the risk before products reach the patients.
A similar example as mentioned by others, Medtronic recalled Sprint Fidelis Defibrillator Leads. After complaints of lead fractures and inappropriate shocking, As a result of the 2007 recall, some patients had to undergo an explant procedure to have the leads removed and have new defibrillator leads implanted.
Ref: https://pmc.ncbi.nlm.nih.gov/articles/PMC10229026/
https://www.sciencedirect.com/science/article/pii/S092575352300259X#ab005
The Allergan BIOCELL breast implant recall underscores the critical need for proactive, comprehensive quality and risk management in medical device development. While regulatory approval is essential, it must not be the sole benchmark for safety. Companies should implement tools like FMEA during design, robust biocompatibility testing, and stress simulations under real-use conditions to uncover long-term risks early. Encouraging open communication within cross-functional teams and fostering a culture where concerns can be voiced without fear of repercussions is equally vital. Examples like the DePuy metal-on-metal hip implant, Essure device, and Medtronic's defibrillator leads show that patient safety demands rigorous pre-market scrutiny and continual post-market vigilance to prevent such failures from recurring.
