Will an MRI remain as part of the recommendation for patients with silicone breast implants?

According to channel 10 news federal inspectors have reopened  an investigation into complaints by Food and Drug Administration scientists who say they were pressured by their managers to approve high-tech medical scanners that could pose harm to patients.

 The lead inspector overseeing the matter told The Associated Press on Tuesday that the inquiry into the allegations, which were dismissed in February, is being revisited to look at manager misconduct.

 ”The original intent of the investigation was to look at criminal matters and our agents did that,” said Gerald Roy, deputy inspector general for investigations in the Department of Health and Human Services. “But I point toward broader issues that really compelled me to take a second look at this and reopen it from an administrative perspective.”

 The HHS office of inspector general, which oversees the FDA, closed the case in February after finding there was “no violation of law.”

 But the whistleblowers have repeatedly stressed that their grievances involve mismanagement and violations of regulations – which don’t fall under criminal law.

 Nine FDA medical device reviewers alleged in 2008 that agency management overruled their opinions without supporting evidence and tried to intimidate them when they went public with their concerns.

 At issue are CT scanners, MRI machines and other medical devices that use radiation to detect or treat diseases. Many of the devices allow lifelike pictures of the human anatomy, but carry a higher risk from radiation than older scans such as X-rays.

With the approval of silicone breast implants by the FDA came a recommendation that patients obtain an MRI after three years to detect if there is a rupture. Subsequent MRIs are part of the  FDA’s recommendation for as long as the patient has silicone implants. It  is widely believed by most plastic surgeons that an MRI solely for the purpose of detecting a rupture does not create a situation in which the benefits outweigh the risk.  Dr. Stuart Kincaid informs his breast augmentation patients of the FDA guidelines and recommendations. He offers both silicone and saline breast implants and is confident in the safety of both products. Patients should remain aware of the FDA guidelines should they change in the future. It is recommended that breast augmentation patients follow-up with Dr. Stuart Kincaid annually.

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