Monday, September 5, 2011

Recent FDA Advisory Meeting on Implants

It’s amazing what you will find sorting through more than 20 years of stuff.  This picture of 3 implants includes:  top -- an old McGhan double lumen (silicone gel implant surrounded by a saline implant); bottom left – Dow Corning textured silicone implant; and bottom right – Dow Corning smooth silicone implant.  Dow Corning has not made breast implants since approximately 1992.

Last week the FDA met to discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants.  As a condition of placing silicone implants back on the market in 2006, both Mentor and Allergan (McGhan) were suppose to enroll patients in 10-year-long follow up studies on side effects related to implants.  The aim was for 80,000 women.

I agree these studies are needed, but it is difficult to get women to return year after year.  This is evident in the data presented at the meeting:

After two years, about 60 percent of Allergan patients were still participating, but just 21 percent of Mentor patients were involved.

I, like Dr Rob Oliver (Plastic Surgery 101 Blog),  found the requirement of routine MRI screening at three years after getting implants and every two years following to look for silent ruptures to be unrealistic and unnecessary.  Insurance often did not cover this expense to the patient.  The FDA has now removed this requirement.

 

Several advisory panel members said the FDA's requirement that women have frequent MRIs to make sure the implants haven't ruptured is unrealistic and should be removed from the product label. Insurance usually doesn't pay for the scans, so most women don't get them done. But it's the only way to find out whether the implant has ruptured in the absence of symptoms.

The advisory panel did recommend the creation of a nationwide database to follow women who have had silicone-gel breast implants for at least a decade after they had the surgery.  I think it should be for 20 years.

 

 

 

Related posts:

Breast Implants -- Some History (March 3, 2008)

FDA Updates Safety Data for Silicone Breast Implants  (June 23, 2011)

 

 

REFERENCES

Breast Implant Safety to Be Focus of FDA Panel; Emily P. Walker, Washington Correspondent, MedPage Today; August 29, 2011

Breast Implant Follow-Up Far Short of FDA Goals; Emily P. Walker, Washington Correspondent, MedPage Today; August 30, 2011

FDA Panel Calls for Silicone Breast Implant Registry; Emily P. Walker, Washington Correspondent, MedPage Today; August 31, 2011

F.D.A. Affirms Safety of Breast Implants; Gardiner Harris, NY Times, August 31, 2011

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