Revisiting the Biomaterials Crisis of the 1990sRevisiting the Biomaterials Crisis of the 1990s

Trivia Tuesday: Why was there a biomaterials crisis in the 1990s, and what were the long-term lessons of the crisis?

Amanda Pedersen

January 14, 2025

2 Min Read
photo of a researcher preparing a 3D bioprinter to print cells onto an electrode. Biomaterials, tissue engineering concepts.
Liability and litigation concerns caused a major biomaterials crisis in the 1990s that impacted medical device manufacturers.Image credit: Ladanifer / iStock via Getty Images

In the 1990s, public controversies such as those related to the use of silicone-gel breast implants caused many suppliers to withdraw their products from the medical market rather than risk financial liability and class action litigation.

As a result, medical device manufacturers faced significant challenges in sourcing raw materials, particularly polymers and other biomaterials, due to liability concerns and litigation. The crisis led to device shortages, R&D challenges, and increased manufacturing costs.

In 1996, MD+DI interviewed several experts regarding the biomaterials crisis. One expert was Jack Lemons, then-chairman of the American Society for Testing and Materials (ASTM) Committee F-4 on medical and surgical materials and devices.

"The biomaterials crisis is real. One of the more critical factors that have led to this crisis is the liability issue," Lemons told MD+DI at the time. "Industry in the United States is often put in a no-win situation with regard to investment and return on investment. While these companies need to be safe and efficacious in everything they do, they also need to be able to earn a profit."

Lemons also said the biomaterials crisis was impacting students at the university level.

"It's certainly of grave concern to students who are going through formal academic programs and looking toward a future in this field," Lemons said.

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The Biomaterials Access Assurance Act of 1998 aimed to protect biomaterials suppliers from liability as long as they were not involved in the design, manufacture, or sale of the medical device their materials were used in. This U.S. legislation helped stabilize the supply chain by reassuring suppliers they would not face legal risk just for providing raw materials to medical device manufacturers. Medical device manufacturers also worked closely with smaller or specialized suppliers to secure alternative sources of materials and to develop new biomaterials.

The lesson that came out of the biomaterials crisis of the '90s was the need for clear liability frameworks and collaboration between regulatory bodies, manufacturers, and suppliers. The crisis also highlighted the vulnerability of medtech supply chains, something the industry continues to grapple with today.

About the Author

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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