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# Better Implantable Device Testing Needed: Wolfe
- URL: https://www.fdaweb.com/better-implantable-device-testing-needed-wolfe/
- Published: 2019-03-26T12:00:00.000Z
- Updated: 2026-09-15T01:15:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143702

Public Citizen Health Research Group founder and senior advisor **Sidney Wolfe** says FDA should require extensive pre-approval testing of permanent implantable devices, including breast implants. Addressing the agency’s General and Plastic Surgery Device Panel 3/26, Wolfe [said](https://www.citizen.org/sites/default/files/2475.pdf?eType=EmailBlastContent&eId=8ac9e632-c57f-4e65-b78f-0daf486e1806&ref=fdaweb.com) breast implants have caused many serious medical conditions in women, including scarring, pain, and hardening of the breasts when the implants rupture and leak silicone gel.

“Post-approval trials to obtain information that should have been derived before, not after, approval remind us why much more extensive mandatory pre-approval testing on such permanently implanted devices is necessary,” Wolfe said. “Otherwise women, in this case, and both genders, in too many other cases, are serving as unwitting guinea pigs.”

Public Citizen says it has raised concerns since 1973 about serious health problems linked to breast implants. In 1988 and 1991 it petitioned FDA to ban silicone gel breast implants. The agency removed the implants from the market in 1992 but in 2006 allowed them to be sold again under the condition that manufacturers conduct post-approval studies of their long-term safety, the advocacy group says.