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March 9th, 2012 
FAKE NEWS for the Zionist agenda FRIDAY, March 9 (HealthDay News) — A new silicone-gel breast
implant received conditional approval Friday from the U.S. Food and Drug
Administration. The implant can be used for breast augmentation in women
22 and older and for breast tissue reconstruction at any age.
The newest implant, manufactured by Sientra of Santa Barbara, Calif.,
becomes the third approved for use in the United States, joining devices
made by Allergan and Mentor. As a condition for approval, Sientra will
continue studies on the implant’s long-term safety, effectiveness and
risks of rare diseases, the FDA noted.
“Data on these and other approved silicone-gel filled breast implants
continue to demonstrate a reasonable assurance of safety and
effectiveness,” Dr. William Maisel, deputy director for science in the
FDA’s Center for Devices and Radiological Health, said in an agency news
release.
Silicone breast implants have been controversial for years, with
critics contending that the devices can rupture and leak silicone,
potentially causing a variety of health problems, including cancer and
lupus.
Classified as medical devices, silicone implants are surgically placed
under breast tissue or chest muscle to reconstruct or augment the breast.
In reconstruction, the implant usually replaces breast tissue removed
because of cancer or trauma or breast tissue affected by a severe breast
abnormality. Another reason is to revise or improve results from a
previous reconstruction surgery, according to the FDA.
Similarly, breast augmentation is used to increase breast size or to
improve on previous augmentation surgery.
The FDA approval of Sientra’s implant is based on three years of data
from clinical studies on nearly 1,800 patients. Complications included
tightening of the area around the implant, re-operation, implant removal,
uneven appearance and infection, according to the agency’s release.
The company’s additional long-term studies will include a seven-year
follow-up of the current participants; a 10-year study of nearly 5,000
women to monitor long-term complications, including rheumatoid arthritis,
breast and lung cancer; and five studies focusing on possible links
between the new implant and connective tissue and neurological diseases,
brain cancer, cervical/valvular cancer and lymphoma, the FDA said.
Reaction to the latest approval came swiftly.
Dr. John Oeltjen, an assistant professor of plastic surgery at the
University of Miami School of Medicine, thinks the FDA decision is a good
one.
“The implant from Sientra is like the implants from other companies
already marketing implants,” he said. “So that’s not out of line.”
“In general, there are no problems with silicon gel implants,” he said.
The advantage of silicon gel over saline implants is that the silicon has
a more natural look and feel, he added, while saline implants can wrinkle,
which can show through the skin.
However, Oeltjen said he would like to see the FDA also allow marketing
of contoured implants, which are not round, but shaped more like a natural
breast.
Dr. Jeffrey C. Salomon, a clinical professor of plastic surgery at Yale
University School of Medicine, noted, “Sientra is a brand that has been
used in Brazil for an extended length of time, and I doubt that there were
concerns about cancer, otherwise the FDA would have not approved
them.”
He added, “While the next generation of breast implants is the
so-called form stable variety, those implants have not been released in
the U.S. despite being used throughout the world for a few years.”
“The form stable implant does not develop capsular contracture, which
is a response by the body to a foreign object and can result in pain and
discomfort as the implant is squeezed by fibers created by the immune
system,” he added. “And that is really the category of breast implant
surgeons are anticipating the release of.”
Silicone gel implants had been banned in the United States for 14
years, until 2006 when the FDA approved the ones made by Allergan and
Mentor for breast reconstructive surgery and for breast enlargement in
women 22 and older.
But, when the ban was lifted, the FDA noted that there wasn’t a lot of
data on adverse effects, including what the agency called “rare events”
and “long-term performance.” In light of this, the agency required the
manufacturers to do studies on the implants’ safety and performance after
their approval.
Then last September, after a contentious two-day hearing, the FDA ruled
that silicone implants were safe and could remain on the market. However,
the agency said at the time that it would work with manufacturers of the
devices approved for use in the United States to improve studies gauging
the health of women who received the implants.
The FDA emphasized last year that silicone implants don’t last forever,
with as many as half of women with such implants requiring removal within
10 years of the initial surgery. According to the agency, one in five
women who receives silicone implants to increase the size of her breasts
will need to have the devices removed within 10 years due to
complications. And as many as half of women who receive implants for
reconstruction after breast surgery will need them removed within the same
time frame.
Common complications include: hardening of the area around the implant;
the need for additional surgeries; and implant removal. Other frequent
problems include implant rupture, wrinkling, breast asymmetry, scarring,
pain and infection, the FDA said.
The FDA recommends that women who get silicone implants: follow-up
regularly with their doctor, which includes occasional MRIs to detect
potential ruptures; pay attention to any changes and notify their
health-care provider if they notice any unusual symptoms such as pain,
asymmetry or swelling; and educate themselves on the signs and symptoms of
complications.
“It’s important to remember that breast implants are not lifetime
devices,” Maisel said. “Women should fully understand risks associated
with breast implants before considering augmentation or reconstruction
surgery, and recognize that long-term monitoring is essential.”
According to FDA estimates, 5 million to 10 million women worldwide
have breast implants.
More information
The U.S. Food and Drug Administration has more about breast implants.
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