Thursday, March 14th, 2013
Here is my latest article in the Huffington Post:
The statistics are in. 2012 is officially the year of the silicone breast implant.
Every year the American Society for Aesthetic Plastic Surgery (ASAPS) publishes annual cosmetic surgery statistics from the year before. The numbers released on Tuesday, March 12th reveal that breast augmentation is the most popular cosmetic surgery in the United States. In 2012, 0ver 330,000 women underwent this procedure. Of these patients, 72% chose silicone gel breast implants and 28% selected saline-filled implants. The number of women choosing silicone has skyrocketed since the FDA lifted the moratorium on these implants in November, 2006.
So what will 2013 bring?
This February the FDA approved the Allergan 410 form-stable, shaped breast implant for general cosmetic use. This implant, also known as the “Gummy Bear Implant,” is considered by many plastic surgeons to be superior due to its firm composition. It literally feels like a gummy bear. Plastic surgeons and patients have been waiting over ten years for this implant to be approved. I suspect that the number of women undergoing surgery with these implants will boom in 2013.
What else is on the horizon?
To read the rest of the article, visit Huffington Post HERE.
Thursday, February 21st, 2013
This is a very big deal in the field of plastic surgery. Today the FDA approved the Natrelle (Allergan) Style 410 “Gummy Bear” silicone breast implant. This is a true “form-stable” implant, with silicone that literally feels like a gummy bear, hence the name. Plastic surgeons have been predicting the FDA approval of these devices for over ten years, so it’s a long-awaited announcement. From the FDA webpage:
The U.S. Food and Drug Administration today approved the Natrelle 410 Highly
Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase
breast size (augmentation) in women at least 22 years old and to rebuild breast
tissue (reconstruction) 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), re-operation, 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 recognize
that long-term monitoring is essential,” said Jeffrey Shuren, M.D., 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
The silicone gel in the Natrelle 410 implant contains more cross-linking
compared to the silicone gel used in Allergan’s previously approved Natrelle
implant. This increased cross-linking results in a silicone gel that’s firmer.
Cross-linking refers to the bonds that link one silicone chain to another. The
clinical significance of this type of silicone gel is not known.
These implants are completely different from the silicone gel implants otherwise on the market. They are much firmer and hold their shape, unlike the current silicone implants in use. Time will tell just how popular these implants will get. Some things to consider with the Natrelle Style 410 silicone gel implant:
1. The textured surface and teardrop shape mean that these implants are made to stay in place. Unlike the smooth-walled silicone implants currently used by most plastic surgeons, these implants are not made to move. For some, the fact that these implants stay in their position might be construed as looking and feeling less natural.
2. They are FIRM.
3. The incision necessary to insert these implants is much longer than a traditional incision, since these implants can not be squeezed into a smaller opening.
4. The plastic surgeon who inserts these implants must be very accurate in the creation of the breast pocket. You DO NOT want some careless doctor ripping open a breast pocket and trying to stuff one of these in you. Make sure to see a reputable plastic surgeon who’s a member of the American Society of Plastic Surgeons and/or the American Society for Aesthetic Plastic Surgery.
5. The gummy bear implants can’t be inserted through the belly button or the armpit. They are too stiff.
6. These implants can be useful in reconstruction, revision breast surgery, and in people with really thin tissues and a risk of bottoming out.
To read the FDA announcement about the Natrelle Style 410 “Gummy Bear” Implant approval, click HERE.
Saturday, December 8th, 2012
This a recent segment I did with Fox News. We discuss the current types of breast implants, including silicone, saline, and the new, FDA approved ‘gummy bear’ breast implants. I also compare two vastly different sizes, and discuss who has what!
Thursday, November 1st, 2012
Wednesday, September 19th, 2012
A new study on an investigational breast implant shows that it could have some considerable benefits compared to the currently utilized breast implants. According to a study published in the Aesthetic Surgery Journal, the Ideal Implant (a double-lumen, saline-filled breast implant) has a high rate of patient and surgeon satisfaction, low rate of wrinkling, and a surprisingly low rate of capsular contracture when compared to the single lumen saline implants used today. Here are the results:
Two-year follow-up visits were completed by 472 of the 502 women (94.0%) enrolled at 35 private practices, 378 of whom had undergone primary breast augmentation and 94 of whom had received replacement augmentation. Patient-reported satisfaction with the outcome was 94.3% for primary augmentations and 92.3% for replacement augmentations; surgeon-reported satisfaction was also high (96.5% and 93.4%, respectively). The incidence of moderate-to-severe wrinkling was 3.8% (primary) and 12.0% (replacement). Baker Grade III and IV capsular contracture rates were 3.8% (primary) and 8.2% (replacement). These two-year rates are lower than those reported for current single-lumen saline implants at one year. Deflations, none of which were caused by a shell fold flaw, occurred in 4.8% of primary augmentations and 3.3% of replacement augmentations.
I’ve had the privilege of examining the Ideal Implant and talking with its developer, and so far I’m impressed. The implant feels more natural than traditional saline implants, but without the controversy of silicone implants. Unfortunately, it’s not FDA approved yet. When it does achieve FDA approval, however, I will announce it on this site!
For more information on the Ideal Implant, click HERE to visit their website.
Tuesday, April 10th, 2012
A recent study printed in the Cosmetic Surgery Times revealed that over half of 800 women surveyed are willing to wait for the FDA to approve form-stable “gummy bear” breast implants. Gummy bear breast implants have been hailed world-wide as the only ones that simply don’t leak. The devices, already approved in Europe and Canada, have yet to receive FDA approval here in the United States.
Or have they?
Recently the FDA approved the silicone breast implants of a company called Sientra, the third company to have approval of breast implants in the U.S. (along with Allergan and Mentor). Among the Sientra implants approved are, yes, their version of the gummy bears. Sientra has yet to distribute their implants to doctors, but have plans to do so in the near future. This is an exciting development in the field of plastic surgery, and an event plastic surgeons and patients have been waiting years for.
I suspect that FDA approval of Mentor’s gummy bear implants aren’t far behind.
Saturday, March 10th, 2012
The FDA has approved the silicone breast implant from the manufacturer Sientra. From the FDA website:
FDA approves new silicone gel-filled breast
Approval conditioned on post-approval safety studies
Today, the U.S. Food and Drug Administration approved a silicone gel-filled
breast implant manufactured by Sientra Inc. 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.
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
With today’s approval, there are now three FDA-approved silicone gel-filled
breast implants in the U.S. manufactured by Allergan, Mentor and Sientra.
“Data on these and other approved silicone gel-filled breast implants
continue to demonstrate a reasonable assurance of safety and effectiveness,”
said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s
Center for Devices and Radiological Health.
“It’s important to remember that breast implants are not lifetime devices.
Women should fully understand risks associated with breast implants before
considering augmentation or reconstruction surgery, and recognize that long-term
monitoring is essential.” said Maisel.
The FDA based its Sientra approval on three years of clinical data from 1,788
participants. Complications and outcomes reflected those found in previous
studies of other breast implants and included tightening of the area around the
implant (capsular contracture), re-operation, implant removal, an uneven
appearance (asymmetry), and infection.
In June 2011, the FDA released a report that included preliminary safety data
from post-approval studies from earlier breast implant approvals. The experience
collecting and analyzing data from these studies informed the design and
structure of post-approval studies for Sientra breast implants.
In addition to other post-approval conditions, Sientra will:
“The design of these post-approval studies will require Sientra to collect
valuable safety information with adequate enrollment and follow-up,” said
Maisel. “The FDA is committed to working with breast implant manufacturers to
collect useful post-market data on long-term safety and effectiveness.”
My comment: This is a big deal in the plastic surgery field. Mentor and Allergan (aka McGhan) have been the only real players in the breast implant market for 20 years. Although Sientra’s implants are now approved for use, their products remain unknown to the vast majority of plastic surgeons. Study results have not been publicly released (to my knowledge), and therefore how Sientra’s implants stack up to Mentor and Allergan’s is still in question.
Breast augmentation is the number one cosmetic plastic surgery in the country, with over 300,000 women undergoing the surgery each year according to the American Society of Plastic Surgeons. If Sientra’s implants test as well as the other two companies AND have a lower price, then we may see more and more women being able to afford breast augmentation. I’ll report on the new Sientra silicone breast implant as information is released.
Thursday, March 1st, 2012
Last month 30,000 French women were urged by their government to have their PIP breast implants removed. The French Ministry of Health fears that the implants’ industrial-strength silicone filler, originally made for mattresses, could leak and cause serious health problems.
So what should American women with breast implants do?
Thank the Food and Drug Administration.
Breast implants are big business. According to the American Society of Plastic Surgeons, last year nearly 300,000 women underwent breast augmentation in the United States. I currently perform over 150 breast implant surgeries per year, by far my most popular procedure.
So what went wrong in France that hasn’t gone wrong here?
The implants under scrutiny were manufactured by the now-defunct Poly Implant Prosthese (PIP), at one time the world’s third largest supplier of breast implants. The company, which went bankrupt and liquidated in 2010, fitted approximately 300,000 women around the world with these devices.
The advice given to women regarding their PIP implants has varied from country to country. France and Venezuela have urged their affected citizens to have the implants removed as soon as possible, while Britain has stated there is no evidence to recommend routine removal in all patients. Women with PIP implants around the world are furious that their government’s health ministries have allowed these unsafe implants to be used in so many people.
Here in the U.S., two companies manufacture the bulk of breast implants, Allergan and Mentor. The saline and silicone implants from both companies have stood up to the rigorous testing standards of the FDA.
Interestingly, PIP submitted their saline breast implants for FDA approval, but was rejected in March 2000. Specific reasons behind the FDA denial are unclear, but a study published in Plastic and Reconstructive Surgery by Stevens, et al., may provide a big clue. They discovered PIP saline implants had 3.5 times the rupture rate of Mentor saline implants. When an unacceptably high rupture rate is combined with contaminated silicone many complications can occur, including infection, inflammation, scar tissue, and possibly even cancer.
PIP silicone breast implants were never really used in the United States. If you had your breast augmentation in the U.S., it’s highly unlikely that you have these defective devices.
However, if you had your surgery overseas, then it’s a good idea to obtain your breast implant information from your surgeon. If your implants were manufactured by PIP, it may be a wise decision to switch them out for Mentor or Allergan implants.
If you’re thinking about undergoing a breast augmentation, don’t be afraid of silicone. Silicone breast implants are quite possibly the most studied medical device in the history of the world, and the FDA has deemed them safe for use.
Make sure you consult with a surgeon certified by the American Board of Plastic Surgery and a member of the American Society of Plastic Surgeons. Discuss the pros and cons of saline versus silicone. Recent surveys have found that, while silicone breast implants account for 60% of sales, a significant number of patients are still undergoing augmentation with saline. Silicone implants look and feel more natural than saline, but a broken silicone implant is harder to detect than a broken saline implant.
Studies show that over 90% of women with breast implants are satisfied with their outcomes. Still, I turn down one out of every five women who consult for breast augmentation, usually because I believe it’s not right for them.
Breast implants aren’t for everyone.
But the implants used in the United States are safe.
Thursday, December 29th, 2011
Interesting and scary story out of France. A breast implant manufacturer, Poly Implant Prosthese, has been accused of using non-medical silicone (made “for mattresses”) in their breast implants. Approximately 30,000 women in France have these implants, which have an unacceptably high rupture rate. According to an article in CNN.com:
This shows the importance of the FDA regulatory process, as long and drawn-out as it may sometimes be. PIP saline implants were rejected by the FDA in 2000, a very appropriate move. If you are in the United States, make sure your breast implants are made by either Mentor or Allergan. A new implant, The Ideal Implant, may be on the horizon, but isn’t FDA approved… yet.
To read the CNN.com article, click HERE.
Tuesday, September 20th, 2011
Friday, September 2nd, 2011
Silicone breast implants are back under the FDA’s microscope. Silicone implants were under original widespread use in the 1980′s and early 1990′s. Fears of silicone implants causing various diseases like lupus and arthritis prompted the FDA to ban the use of them in 1992. After analyzing studies by the two major breast implant manufacturers (Mentor and Allergan), the FDA lifted the moratorium on silicone breast implants in 2006, ruling them safe and effective, on the condition that 10 year post-approval studies were performed.
An FDA Panel recently met with patients, plastic surgeons, and representatives of Allergan and Mentor to discuss the results from the post-approval studies. CNN.com has an excellent article about their findings, summarized below:
To read the rest of the CNN.com article, click here.
Wednesday, January 26th, 2011
The FDA has issued a statement alerting physicians and patients to a possible link between breast implants and a rare type of cancer. Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing the condition.
ALCL in the presence of breast implants has been noted in sporadic case reports over the past 25 years. To date, ALCL has only been identified in 34 cases out of an estimated 5 to 10 million women with implants worldwide. As opposed to systemic ALCL which can occur anywhere in the body, this condition appears in the scar tissue that forms around the implant. It is encouraging that when this condition occurs in the presence of breast implants the patients have responded to a variety of treatments, including simple removal of the implant and surrounding scar capsule.
ASAPS (American Society for Aesthetic Plastic Surgery) recommends that all women including those with breast implants should follow their normal routine in medical care and follow-up, specifically regular self examination and mammography when appropriate. Any woman should watch for changes in her breasts such as pain and swelling and contact her physician if she has any questions.
For my patients with breast implants, I don’t recommend that they lose any sleep over this. The disease is very rare and a connection between ALCL and breast implants has not been conclusively proven. There is some thought that the salt-texturing of the shell of a textured breast implant may be the connection between breast implants and ALCL. Joan Kron’s excellent article in Allure (which can be found here) touches on this hypothesis.
Here are the recommendations from the American Society of Plastic Surgeons (ASPS):
For the FDA press release, click here.
For the ASPS website, click here.
Wednesday, April 29th, 2009
Thanks for reading.
Michigan-based Plastic Surgeon
Anthony Youn, M.D.
Saturday, September 27th, 2008
October is National Breast Cancer Awareness Month. Each year over 175,000 women (and 2000 men!) are diagnosed with breast cancer. Approximately 1 in 9 women will be diagnosed with breast cancer in their lifetime. Aside from skin cancer, it is the most common cancer in women. So how does this affect you if you have breast implants?
It’s estimated that over 5 million women have breast implants today. If you have breast implants, how do you screen yourself for breast cancer, and how is this different from someone without implants?
The major rule is that you should follow the American Cancer Society guidelines for the early detection of breast cancer. Here they are:
Women ages 20-39: Monthly breast self-exam, clinical exam by your physician every three years.
Women ages 40 and up: Monthly breast self-exam, clinical exam by your physician every year, mammogram yearly.
Women at high risk (close family history of breast cancer, etc.) should discuss with their physician whether a yearly MRI may be indicated. – When the FDA lifted the ban on silicone gel breast implants in November 2006, they recommended that anyone who undergoes silicone gel breast augmentation undergo an MRI three years after surgery, and every other year thereafter.
If you have breast implants, here are some other things to consider:
For more information on breast cancer and screening, visit http://www.cancer.org/.
Thanks for reading!
Anthony Youn, M.D.
Thursday, September 20th, 2007
I was recently featured on a the local Fox affiliate here in Detroit in a segment about the rising popularity of silicone gel implants. They follow one of my patients through her breast augmentation surgery with Memory Gel implants. Check it out here if you have a minute and are interested.
Thanks to Lila Lazarus and Sean Lee of Fox 2 Detroit for the nice story!
Thanks for reading.
Michigan-based Plastic Surgeon
Anthony Youn, M.D.
Friday, November 17th, 2006
The FDA has just lifted the 14 year ban on silicone gel breast implants. The moratorium was placed on these implants after numerous women came forward with what were believed to be arthritis and other diseases from gel implants. Subsequent large scale studies have not proven any connection between silicone gel implants and these “connective tissue diseases.”
What’s the difference between gel implants and saline implants? A lot. Prior to today, the U.S. was the only major industrialized country to ban the use of these implants. Gel implants feel and look much more realistic than saline implants. There is no comparison between the two cosmetically.
MEDIA: If you would like to speak with me about the subject of silicone gel breast implants, feel free to email me at email@example.com or call my office at 248-650-1900 and have me paged if it is after hours.
Thanks for reading.
Michigan-based Plastic Surgeon
Anthony Youn, M.D.
Tuesday, October 3rd, 2006
In Touch Magazine is reporting that Kimberly Stewart appears to have had her breast implants removed. I seem to remember her having them removed some time before??
Wednesday, September 13th, 2006
Has Beyonce had a breast augmentation? The photo linked below shows what might be evidence of a breast augmentation through the armpit. Breast implants can be placed most commonly through the armpit, underneath the breast, and around the areola. The implants are often placed through the armpit in people with darker skin, as this area is known to be resistant to keloid formation. Unfortunately, some people can develop a band of scar tissue which extends between the armpit scar and the breast implant pocket. It can even create a pulling sensation, and resemble a band such as may be seen here.
Photo credit: prphotos.com
Friday, August 18th, 2006
This has nothing to do with celebrities, but I thought it was a great story to tell. A 24 year old Isreali woman was recently struck with shrapnel during the Hizbullah/Israeli conflict. Pieces of the shrapnel were found imbedded in her silicone breast implants, just inches from her heart. A hospital spokesman announced that the implants “saved” her “from death.”
Who says plastic surgery can’t save a life?
Story credit: plasticsurgery101.blogspot.com