Health trends - New silicone gel-filled breast implant approved

The
United States Food and Drug Administration recently approved the
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled
Breast Implant to increase breast size in women at least 22 years old
and to rebuild breast tissue in women of any age. Natrelle 410 implants
are manufactured by Allergan, Inc.

The FDA based its approval on
seven years of data from 941 women. Most complications and outcomes
reflect those found in previous breast implant studies including
tightening of the area around the implant (capsular contracture),
reoperation, implant removal, an uneven appearance (asymmetry), and
infection. In addition, investigators observed fissures (cracks) in the
gel of some Natrelle 410 implants. This is a characteristic called gel
fracture and is unique to this implant.

"It's important to
remember that breast implants are not lifetime devices. Women should
fully understand the risks associated with breast implants before
considering augmentation or reconstruction surgery, and they should
recognise that long-term monitoring is essential," said Jeffrey Shuren,
MD, director of the FDA's Center for Devices and Radiological Health.

"The
data we reviewed showed a reasonable assurance of safety and
effectiveness," said Shuren. "We will be looking at the results from
post-approval studies that will focus on their long-term safety and
effectiveness."

Source: The US Food and Drug Administration