26. Miller H. To America’s Health: A Proposal to Reform the Food
and Drug Administration. Stanford, CA: Hoover Institution
27. Promise for Antibiotics and Therapeutics for Health
(PATH) Act S. 185, 114th Congress. 2015. Available at:
text/. Accessed October 16, 2015.
28. The Plastic Surgery Foundation. PROFILE: Investigating
Breast Implant Associated ALCL. Available at: www.
thepsf.org/research/clinical-impact/profile-investigating-breast-implant-associated-alcl.htm. Accessed October 23,
29. U.S. Food and Drug Administration. Anaplastic Large
Cell Lymphoma (ALCL). Available at: www.fda.gov/
Accessed October 26, 2015.
30. Keech JA Jr., Creech BJ. Anaplastic T-cell lymphoma in
proximity to a saline-filled breast implant. Plast Reconstr
Surg. 1997; 100( 2):554-555.
31. Brody GS, Deapen D, Taylor CR, et al. Anaplastic large
cell lymphoma (ALCL) occurring in women with breast
implants: Analysis of 173 cases. Plast Reconstr Surg.
32. Madison J. The Federalist no. 51, 1787.
REFERENCES (CONTINUED) capsule surrounding breast implants first appeared. 28
None are cancers involving the breast gland itself but
instead anaplastic large cell lymphoma (ALCL). Without
an exact number of women with implants worldwide
(estimates range from 10 million to 20 million), an incidence rate cannot be precisely determined. The FDA
places the risk of ALCL at two or three per million. 29
Fortunately, the FDA has taken a more measured
view than its 1991 reaction to unsubstantiated breast
implant linked diseases by stating, “The FDA believes
that women with breast implants may have a very low
but increased risk of developing ALCL adjacent to the
breast implant.” 30 Because these tumors are believed
to be a manifestation of chronic inflammation and not
specific to silicone, it is not unreasonable to expect they
might arise in capsules known to form around any
implanted device, so there is ample motivation for all
surgical specialties to monitor the problem and maintain a liaison with the FDA. 31
In the face of power, we are advised to speak truth.
When the opponent is a government agency, success
requires a listener willing to act on the basis of scientific principle, not political bias. James Madison said it
another way: “In framing a government to be administered by men over men, first enable the government to
control the governed; then oblige it to control itself. 32 ♦
For more information, see Silicone on Trial: Breast Implants
and the Politics of Risk, by Jack C. Fisher, The Sager Group,
La Jolla CA, 2015.
Residency program directors wanting their residents to
learn more about regulation in America including policies
for drug and device approval should contact Dr. Fisher for
access to discounted copies at Jfisher37@icloud.com