No Recall for Breast Implants, FDA says, Mass Device, September 1, 2011

//No Recall for Breast Implants, FDA says, Mass Device, September 1, 2011

No Recall for Breast Implants, FDA says, Mass Device, September 1, 2011

Despite the fact that there are no long-term safety data, the FDA announced there will be no recall for silicone breast implants. That announcement was made a after a two-day panel of the General and Plastic Surgery Devices group reports Mass Device. Allergan Inc and Johnson & Johnson had promised to track long-term safety but had failed, said consumer groups. The FDA told manufacturers to ramp up their efforts to track devices postmarket.

The two companies won clearance for silicone breast implants in 2006 based on the condition they would be gathering post market safety data on 40,000 patients for up to 10 years. Patient complaints to the FDA have included hardening skin around the implant, ruptured implants, scarring, infection and pain.

 

By | 2011-09-03T03:11:44+00:00 September 3rd, 2011|Media Reports|0 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

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