Rupture

Breast implants are devices that sometimes fail. Failure rates are exceedingly low because of recent improvement in materials and designs. The rate of rupture among breast implants ranges from one to five percent over ten years. Think about how often a person must replace a DVD player over the course of ten years. Realize that a one to five percent rupture rate is very low. When a saline implant ruptures, the body simply absorbs the leaking saltwater. The scar tissue surrounding the implant usually holds any silicone gel material that leaks out of an implant, which is an intracapsular rupture. In rare cases, particularly after a longstanding ruptured silicone implant, the gel may slowly reach beyond the capsule layer and make its way into the breast tissue itself and beyond in an extracapsular rupture and gel migration. Migrated silicone gel is difficult or impossible to remove. The ruptured silicone causes increased inflammation around the implant leading to firmness of the implant and the breast. An implant can rupture can due to injury, trauma, during a mammography, failure of the implant shell or from no identifiable cause at all. Since the body cannot absorb silicone, doctors do not immediately identify a ruptured silicone breast. Eventually the implant changes shape and the body reacts to the silicone as a foreign, thereby alerting doctors that something is wrong. Surgeons cannot repair damaged or broken implants. According to the FDA, ruptured or damaged implants require replacement or removal. Breast implants can wear out; manufacturers do not guaranteed implants to last a lifetime and patients will need to undergo future surgery to replace or remove one or both implants. Surgeons can easily diagnose when a saline implant fails because the breast will simply deflate over a period of one to seven days. Doctors have a harder time diagnosing a ruptured silicone implant. If a patient has an implant that is over 10 years old and is from the generation before cohesive implants, doctors can mostly accurately determine the condition of a silicone implant by having the patient undergo an MRI (magnetic resonance imaging). A "linguini sign" or an image that reveals an implant shell free floating in a capsule of ruptured silicone, indicates a rupture. Yet MRIs may not be 100 percent accurate in diagnosing implant integrity, particularly in modern "cohesive" implants, which do not leak liquid silicone as quickly or heavily. High clinical suspicion and images from the MRI help doctors to determine whether or not to remove an implant. The FDA recommends regular screening and MRI examinations. Specifically doctors advise patients to undergo serial MRI examinations, starting at three years after surgery and then every two years thereafter.

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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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