Tag Archives: chest muscle

Ask the Plastic Surgeons

Q. I understand that the FDA recently approved a new silicone gel-filled breast implant by a company called Sientra.  what is a gel-filled implant and how is it used?

A. On March 9, 2012, the U.S. Food and Drug Administration (FDA) approved a silicone gel-filled breast implant manufactured by Sientra, inc. (based in Santa Barbara, CA) to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. as a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes. The FDA based its Sientra approval on three years of clinical data from 1,788 participants.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. they come in different sizes and have either smooth or textured shells.

Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. With this recent new approval, there are now three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and most recently, Sientra.

In our practice, we begin with a private, complimentary consultation that serves to determine desired results for breast augmentation. there are multiple options when it comes to breast implants and we encourage all patients who are seeking this procedure to discuss all alternatives thoroughly with their physician.  we see an increase in inquiries this time of year as women prepare for the upcoming summer swimsuit season. Spring is an opportune time for this procedure as patients are usually able to return to work within a week of breast augmentation, and can resume all other normal activities after two to four weeks. Scars will begin to fade after a few months. our patients find that shopping for clothes and participating in summer activities are far more pleasurable, and usually report an increased sense of self-confidence.

John Smoot, MD, is Chief of Plastic Surgery at Scripps Memorial Hospital-La Jolla and Wendell Smoot, MD, has been voted by his peers as Top Doctor in San Diego for five consecutive years.  Carol Hollan, MD, is San Diego’s first female board-certified plastic surgeon while Reza Sadrian, MD, is one of very few plastic surgeons dually certified in plastic and reconstructive surgery as well as oral and maxillofacial surgery.  The practice has over 20 years of tenure in the industry and each is individually board certified by the American Board of Plastic Surgery.  any of the physicians can provide consultations on plastic surgery procedures and/or laser and skincare treatments at their Laser and Skincare Center and can be reached at their offices on the campus of Scripps Memorial Hospital-La Jolla in the Ximed Medical Building by calling (858) 587-9850 or via the web at sandiegoplastiscurgeryclinic.com.

By Wendell Smoot, MD, Reza Sadrian, MD, Carol Hollan, MD and John Smoot, MD

Short URL: http://www.ranchosantafereview.com/?p=9377

Ask the Plastic Surgeons

FDA OKs 3rd Silicone-Gel Breast Implant – MedicineNet

By Steven Reinberg and Lisa EspositoHealthDay Reporters Latest Womens Health News

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.

MedicalNewsCopyright © 2012 HealthDay. All rights reserved.

SOURCES: March 9, 2012, news release, U.S. Food and Drug Administration; John Oeltjen, M.D., assistant professor of plastic surgery, University of Miami School of Medicine; Jeffrey C. Salomon, M.D. clinical professor of plastic surgery, Yale University School of Medicine, New Haven, Conn.

FDA OKs 3rd Silicone-Gel Breast Implant – MedicineNet

Philippine Plastic Surgeon Blog » Blog Archive » Facts on Breast Augmentation

Breast Augmentation, also known as, augmentation mammoplasty is the type of plastic surgery that involves placing of silicone or saline breast implants either behind the breast tissue or beneath the chest muscle to add size, shape, and fullness to the breast. Breast augmentation can be performed to make smaller breasts appear larger, balance breasts that are asymmetrical, or restore fullness that has diminished with age or as a result of pregnancy. this procedure to enhance and increase the size of a woman’s breast is one of the most popular cosmetic surgery procedures.

The surgery consists of making an incision, lifting the breast tissue, creating a pocket in the chest/breast area, and placing an envelope containing a soft, natural feeling implant material underneath. although several implants are available at the present time, the implant which is used nearly universally for augmentation purposes is made of a silicone rubber sack, which is filled with a saline solution. under certain conditions, silicone gel implants can be used. there are a variety of implant designs, all of which have advantages and disadvantages. Your surgeon will discuss the choice of implant, reasons for the selection, and will review with you the size changes that are possible with the operation. the surgical time for a breast augmentation is dependent upon many factors including the surgical approach used, location of the breast implants, the patient’s anatomy, and type of anesthetic used. Generally, the procedure requires a range of 1-3 hours.

Selecting a breast surgeon is undoubtedly the most important decision a patient can make about her breast augmentation. in addition to being board certified and experienced in breast enhancement surgery, the surgeon should be someone the patient feels comfortable with. Good credentials provide a reasonable indication of a doctor’s qualification to perform cosmetic surgery, and should serve as the basic starting point. Patients should then ask the surgeon about his experience. How long has he been in practice and how many times has he done the procedure you are considering? the broader your surgeon’s experience are, the greater your chances for a successful surgery.

Breast augmentation is fairly safe, but no procedure is completely risk free. some of the more common possible complications include postoperative infection, hematoma (a blood clot in the breast tissue requiring evacuation of the blood clot during a subsequent surgical procedure), implant rupture, deflation or leakage, capsular contracture, calcium deposits, changes in nipple or breast sensation, interference with mammogram readings, shifting of the implant.

Tags: breast augmentation, breast augmentation surgery, breast surgery, cosmetic surgeon, facts on breast augmentation, philippine cosmetic surgeon, philippine plastic surgeon, plastic surgeon, surgeon, surgery

this entry was posted on Wednesday, June 16th, 2010 at 4:22 pm and is filed under Cosmetic Surgery Facts. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

Philippine Plastic Surgeon Blog » Blog Archive » Facts on Breast Augmentation