Hi,
To my knowledge, I think there are no rules in this regard, as of now.
Please read through the US government website below:
http://www.fda.gov/oc/fdama/fdamawebcast/stakeholdersquestions/devices.html
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Q. What failure rate of silicone gel-filled implants is acceptable to the FDA?
A. Silicone gel-filled breast implants are available only as part of a
clinical study conducted under an Investigational Device Exemption
(IDE) or under an adjunct study that was established to provide access
to these breast implants for women undergoing reconstructive surgery.
Once the trials are completed, a company must submit a PMA (premarket
approval application) to the Agency to get approval for commercial
marketing. The PMA would be reviewed by the FDA to determine whether
there is a reasonable assurance of the safety and effectiveness of the
device. It is important to note that FDA relies on "valid scientific
evidence" when determining safety and effectiveness. Data establishing
the rupture rate associated with any particular breast implant would
certainly be considered as part of this review. However, FDA typically
does not set pre-defined failure rates that it considers acceptable or
not acceptable when reviewing PMAs.
Q. With over 170,000 adverse events reported on breast implants alone
and Baylor College of Medicine research documenting fatal toxic liver
and lung damage in mice to low molecular weight silicones, what
modernization efforts have been put into place to improve MedWatch
reporting to track the long term consequences of implants?
A. The MedWatch reporting system relies on healthcare professionals
and consumers to feed it information. There are ongoing efforts to
improve postmarket surveillance, including the proposed Medical Device
Surveillance Network (MedSun). This is a network that will enable user
facilities to improve and to increase reporting of adverse events
associated with medical devices. However, the MDR system is generally
not a suitable data system for evaluating "the long term consequences
of implants." MDR is very useful for finding signals of public health
problems. In fact, the instances of rupture reported to MDR were one
very important impetus for FDA to study rupture. FDA has made a
significant investment in a study of breast implant rupture and the
results from that study are anticipated this summer or fall.
Within CDRH, postmarket reengineering efforts are underway to
determine the best ways to receive and utilize data from adverse event
reports. With respect to breast implants in particular, FDA also
offers a breast implant reporting packet to all people who request it.
This packet gives detailed instructions on how to fill out a MedWatch
form. It also gives an example of one that is filled out for easy
reference. In addition, postmarket studies for breast implants under
510(k) have been reaffirmed with the manufacturers. FDA issued orders
to all manufacturers of saline breast implants that requiring the
continuation of postmarket studies for these implants.
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Regards
epedia |
