of a single unethical surgeon and his business partners who lied about the safety of their intrauterine
device, efforts to pass medical device amendments
advanced quickly to become law in 1976.20
Impact on surgical innovation
Today’s surgical innovator must be prepared for an
encounter with regulators. Whether it be an improved
procedure, a new device, or an untested treatment
regimen, regulatory approval will require justification
based on measured outcomes. Surgeons of all stripes,
including residents in training, are advised to learn
more about the origins and expanding power of regulation, how the FDA is organized and what it requires
from innovators, and why significant change may not
come quickly or easily—certainly not without new
legislation to support it.
To this day, the FDA has yet to accept the conclusions of the IOM panel. In fact, its website continues
to list autoimmune disease as a possible risk of breast
implants, even though the number of epidemiologic studies that disprove any disease linkage now
exceeds 30. 21 It took seven more years of filing applications, conducting studies, monitoring results,
responding to demands for more data, resolving deficiency reports, testifying at hearings, receiving denials,
resubmitting applications, gaining advisory panel support, negotiating label requirements, and accepting
limitations on product use before the two remaining
manufacturers received conditional approval to market
a full line of devices for reconstructive and cosmetic
surgery in November 2006.22
Regulation does not have to function in this manner.
The evaluation and approval of medical devices in
Europe does not involve government regulators
directly. Instead, “notified bodies” test and certify
according to established standards. Silicone devices in
Europe now benefit from polymer innovations a decade
ahead of the U.S., where a polymer change requires
a new filing that starts the approval clock ticking all
over again. The European Medicines Agency (EMA) is
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10. Transcript of proceedings, FDA Advisory Panel for
General and Plastic Devices, November 22, 1988.
11. Casetext Inc. Hall v. Baxter Healthcare Corp. Available at:
Accessed October 16, 2015.
12. Kessler DA. Food and Drug Administration. U.S.
Department of Health and Human Services. HHS
News. Pub. No. P92-11. Statement on Silicone Gel Breast
13. Transcript of Diane Rehm Show, interview of David
Kessler on Jan. 8, 1992. Diversified Reporting Services,
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