Saline implants have a silicone rubber shell that is inflated to the desired
size with sterile saline. The implants are placed under the pectoralis muscle deflated and therefore, the incision used for this type of implant is
minimal. These implants can be overfilled to achieve a more rounded appearance.
The FDA has approved the
saline breast implants for breast augmentation / breast reconstruction surgery
for all patients:
On May 10 2000, the FDA granted approval of
saline-filled breast implants manufactured by Mentor Corporation and McGhan Medical. To date, all other manufacturers’
saline-filled breast implants are considered investigational.
implants have some advantages over silicone implants. Silicone implant ruptures
are harder to detect. When saline implants rupture, they deflate and the
results are seen almost immediately. When silicone implants rupture, the breast
often looks and feels the same because the silicone gel may leak into
surrounding areas of the breast without a visible difference.Patients will need an MRI to diagnose a
silicone gel rupture. Replacing a ruptured silicone gel implant is more difficult than repairing a saline implant. Silicone implants also have a higher rate of capsular contracture and a higher deflation rate. Saline implants are also less expensive than the silicone gel implants.
Silicone implants have a silicone rubber shell that is filled with a fixed
amount of silicone gel. Most silicone gel-filled implants are not adjustable
and therefore, the incision used to place the silicone gel implant is larger
than the incision needed for saline implants. The silicone gel implant cannot
be overfilled – it comes in an exact size that cannot be manipulated.
Silicone implants vary in
shell surface (smooth/textured), shape, profile, volume, shell thickness, and
number of shell lumens.
surgeons feel that silicone implants have a more natural look and feel than
saline implants because silicone gel has a texture that is similar to breast
tissue. Each patient differs in the amount of breast tissue that they
have. If a patient has enough breast tissue
to cover the implant, the final result will be similar when comparing saline
implants versus silicone gel implants. If a patient has very low body fat and/or very little breast tissue, the
silicone gel implants may provide a more natural result.
As of 2006,
the FDA has approved the use of silicone gel implants manufactured by the
Mentor Corporation and Allergan (formerly McGhan) for breast augmentation surgery for patients over
the age of 22.
Plastic Surgery Societies Applaud the FDA’s Decision to
Approve Silicone Breast Implants
For Immediate Release: November 17, 2006
Arlington Heights, Ill. (November 17, 2006) –
The American Society for Aesthetic Plastic Surgery and The American Society of
Plastic Surgeons, the two largest plastic surgery membership organizations,
applaud the FDA’s decision today to approve (manufacturer’s) silicone breast
implants and return these devices to the U.S. market. This decision comes 14
years after the FDA restricted access to the silicone implants because of
safety concerns. “This is a great day for American women and the plastic
surgeons who care for them,” said Roxanne Guy, MD,
ASPS president. “Silicone breast implants have been scrutinized more than any
medical device, and we applaud the FDA for making its well thought-out decision
and allowing American women to make informed choices about their health care.”
Today’s FDA decision follows a lengthy
process in which the agency sent “approvable with conditions” letters to the
two silicone breast implant manufacturers in the second half of 2005. The approvable
letter stipulated a number of conditions that the manufacturers needed to
satisfy in order to receive FDA final approval to market and sell silicone
breast implants in the United
States. These letters came after an FDA
advisory panel hearing in April 2005, in which the panel heard more than 20
hours of data presentations from the manufacturers and public comment.
Approximately 300,000 women chose breast
augmentation in 2005, according to ASAPS and ASPS statistics. Nearly 58,000
women had breast reconstruction in 2005, according to ASPS. Both breast
augmentation and reconstruction have been proven in numerous studies to have
psychological and physical benefits for women who choose these procedures.
The ASPS and ASAPS will continue to offer
their assistance to the manufacturers for the conditions set forth by the FDA
related to physician and patient education. One comprehensive example of this
assistance is a joint Web site, breastimplantsafety.org, which offers objective
and science based information regarding saline and silicone breast implants.
The American Society for Aesthetic Plastic
Surgery (ASAPS) is the leading organization of board-certified plastic surgeons
specializing in cosmetic plastic surgery. ASAPS active-member plastic surgeons
are certified by the American Board of Plastic Surgery or the Royal College of
Physicians and Surgeons