Silicone Gel Bleed

Silicone can leak out of the implant without an obvious rupture of the shell. A slow silicone leak occurs through an intact shell. This "silicone bleed" is only noticeable when a doctor removes the implant or when the patient undergoes another type of breast surgery. Older generations of silicone implants bleed more often relative to the newer "cohesive" implants. No study definitively shows clinical consequences associated with a silicone gel bleed. Over time, extremely small amounts of silicone gel material and platinum pass through the shell layer of the implant and coat the outside of the implant. Studies indicate that silicone gel contains small amounts of platinum in its most biologically compatible state (with zero oxidation). Sometimes microgram amounts of platinum appear outside of the silicone gel implant. The presence of platinum may contribute to capsular contracture and lymph node swelling. Overall, evidence suggests that an extremely low level of silicone gel via a silicone gel bleed is of no clinical consequence.

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SPECIAL RULE FOR CERTAIN PAYMENTS

  (B) SPECIAL RULE FOR CERTAIN PAYMENTS OR OTHER
TRANSFERS OF VALUE.—In the case where an applicable
manufacturer provides a payment or other transfer of
value to an entity or individual at the request of or designated
on behalf of a covered recipient, the applicable
manufacturer shall disclose that payment or other transfer
of value under the name of the covered recipient.
(2) PHYSICIAN OWNERSHIP.—In addition to the requirement
under paragraph (1)(A), on March 31, 2013, and on the
90th day of each calendar year beginning thereafter, any applicable
manufacturer or applicable group purchasing organization shall submit to the Secretary, in such electronic form as
the Secretary shall require, the following information regarding
any ownership or investment interest (other than an ownership
or investment interest in a publicly traded security and
mutual fund, as described in section 1877(c)) held by a physician
(or an immediate family member of such physician (as defined
for purposes of section 1877(a))) in the applicable manufacturer
or applicable group purchasing organization during
the preceding year:
(A) The dollar amount invested by each physician
holding such an ownership or investment interest.
(B) The value and terms of each such ownership or
investment interest.
(C) Any payment or other transfer of value provided
to a physician holding such an ownership or investment interest
(or to an entity or individual at the request of or
designated on behalf of a physician holding such an ownership
or investment interest), including the information described
in clauses (i) through (viii) of paragraph (1)(A), except
that in applying such clauses, ‘physician’ shall be substituted
for ‘covered recipient’ each place it appears.
(D) Any other information regarding the ownership or
investment interest the Secretary determines appropriate.
(b) PENALTIES FOR NONCOMPLIANCE.—
(1) FAILURE TO REPORT.—
(A) IN GENERAL.—Subject to subparagraph (B) except
as provided in paragraph (2), any applicable manufacturer
or applicable group purchasing organization that fails to
submit information required under subsection (a) in a
timely manner in accordance with rules or regulations promulgated
to carry out such subsection, shall be subject to
a civil money penalty of not less than $1,000, but not more
than $10,000, for each payment or other transfer of value
or ownership or investment interest not reported as required
under such subsection. Such penalty shall be imposed
and collected in the same manner as civil money
penalties under subsection (a) of section 1128A are imposed
and collected under that section.
(B) LIMITATION.—The total amount of civil money
penalties imposed under subparagraph (A) with respect to
each annual submission of information under subsection
(a) by an applicable manufacturer or applicable group purchasing
organization shall not exceed $150,000.

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