Celebs and their plastic surgery

Articles about Breast Implants

Women Waiting For Gummy Bear Breast Implants

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.

 

FDA Approves New Silicone Gel Breast Implant

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
implant
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
shells.

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:

  • continue to follow the 1,788 clinical trial participants in their pre-market
    study for an additional 7 years;
  • conduct a 10-year study of 4,782 women receiving Sientra silicone gel-filled
    breast implants to collect information on long-term local complications such as
    capsular contracture, as well as less common disease outcomes, such as
    rheumatoid arthritis and breast and lung cancer; and
  • conduct five case-control studies that will evaluate the association between
    Sientra’s silicone gel-filled breast implants and five rare diseases: rare
    connective tissue disease, neurological disease, brain cancer, cervical/vulvar
    cancer, and lymphoma.

“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.

 

Thank The FDA For Your Breast Implants

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.

 

France To Pay To Remove Breast Implants Made Of Silicone “For Mattresses”

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:

  • - The French Health ministry is concerned over a possible cancer link
  • - About 30,000 French women have implants made by PIP
  • - PIP implants are not approved for use in the United States
  • - British officials advise women concerned about implants to talk to their doctor

    • 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.

     

    FDA Affirms Safety of Breast Implants

    Tuesday, September 20th, 2011

    From the New York Times:

    After two days of discussion and testimony about silicone breast implants, a top government health official said he had heard nothing to shake his faith in the safety of the widely used implants. The official, Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices, said silicone breast implants were safe.

    “We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days,” Dr. Maisel said.

    There are risks to the implants, however, Dr. Maisel said, including ruptures, a hardening of the area around the implants, the need to remove the implants, scarring, pain, infection and asymmetry. “Women should feel assured that the F.D.A. continues to believe that currently marketed silicone breast implants are safe,” he said.

    The committee also agreed that patients should no longer be told that they should get a magnetic resonance imaging test three years after getting implants and every two years following. The reason for telling patients to get M.R.I.’s is that silicone breast implants sometimes rupture without women being aware, and an M.R.I. can reveal this unseen problem. But many patients ignore the requirements because M.R.I.’s are expensive and it is not clear what they should do when an unseen rupture is discovered; the risks associated with ruptured implants may not be greater than the risks of the operation needed to take them out.

    “F.D.A. continues to believe, as does the panel, that M.R.I. is the gold standard for evaluating breast implants for silent rupture,” Dr. Maisel said. “But there was consensus among the panel that the requirements for ongoing M.R.I.’s should be removed.”

    For the complete New York Times article, click here.

     

    FDA Panels Put Silicone Implants Under Microscope

    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:

  • Mentor, Allergan admit they’ve lost track of many patients
  • Manufacturers had promised to do major 10-year studies
  • Panel hears from both doctors, patients that are highly concerned, quite pleased
  • FDA says it has much to consider

    • To read the rest of the CNN.com article, click here.

     

    FDA Issues Communication Regarding a Possible Link Between Breast Implants and Anaplastic Large Cell Lymphoma (ALCL)

    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):

    What You Should Know

    • ALCL is extremely rare - of the estimated 10 million breast implants worldwide, only 34 cases of ALCL have been reported since 1989.
    • The FDA believes that any potential risk that women with breast implants will develop ALCL is extremely low.
    • A woman is more likely to be struck by lightning than get this condition.
    • Both the FDA and ASPS are confident that breast implants remain safe and effective.

    What You Should Do

    • If you have implants, continue your normal routine in medical care.
    • Watch for changes – if you notice unusual pain or swelling, contact an ASPS Member Surgeon.
    • As always, those considering breast implant surgery should discuss any potential benefits or risks with an ASPS Member Surgeon.

    For the FDA press release, click here.

    For the ASPS website, click here.

     

    Saline or Silicone Gel? The Results May Surprise You…

    Wednesday, April 29th, 2009

    A recent survey published in the Aesthetic Surgery Journal shows what the current preferences are for breast augmentation surgery. According to a survey of 1746 board-certified plastic surgeons and members of the ASAPS:

    - Sixty percent of surgeons are still using saline implants, and the vast majority of them are using them 75-100% of the time.
    - The majority of surgeons (64%) preferred an incision near the breast crease, while 25% preferred an incision around the bottom half of the areola.
    - The average implant size reported by 81% of surgeons was 300 to 400 cc (which is approximately a small to a full “C” cup bra).
    - Smooth implants, rather than implants with a textured surface, were most often preferred by 92% of respondents because it was the surgeon’s preference, less wrinkling, or overall better results for the patient.
    - Ninety-six percent of surgeons used round, rather than anatomically-shaped, implants.
    - The most common position for implant placement was under the muscle (62% of surgeons).

    With the exception of the majority use of saline implants, these statistics reflect what I see in my practice. I estimate that I use saline implants only 25% of the time, since most patients seem to prefer gel. I utilize three incisions (underneath the breast, around the areola, and the armpit), with the most common being underneath the breast. My average size implant is probably 350-375cc, and I usually use smooth round implants placed under the muscle. I find that these choices usually minimize any complications and revisions.
    To view a breast augmentation I performed on Fox News, click here.

    Statistics source

    Thanks for reading.
    Michigan-based Plastic Surgeon
    Anthony Youn, M.D.

     

    National Breast Cancer Awareness Month

    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:

    1. Breast implants can limit the amount of breast tissue that can be seen on a mammogram. If you have implants, then make sure your mammogram center takes extra pictures (called the Ecklund technique) to allow the radiologist to see as much of your breast tissue as possible.
    2. Some physicians believe breast implants can actually facilitate (or improve) the ability to detect a breast mass on examination.
    3. Studies show that breast implants do not increase your risk of breast cancer, delay your diagnosis of breast cancer, or worsen your prognosis once breast cancer is diagnosed.
    4. If you are unsure how to perform a breast self-exam on implanted breasts, be sure to ask your plastic surgeon.

    For more information on breast cancer and screening, visit http://www.cancer.org/.

    Thanks for reading!

    Michigan-based Plastic Surgeon

    Anthony Youn, M.D.

     

    Breast Augmentation News Story on Fox 2 Detroit

    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.

     

    Gel Implants Are Back

    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 miplasticsurgeon@yahoo.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.

     

    Kimberly Stewart – plastic surgery

    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??

     

    Beyonce Knowles – plastic surgery

    Wednesday, September 13th, 2006

    Has Beyonce had a breast augmentation? This photo 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: perezhilton.com

    To view a video of a breast augmentation I performed for Fox News, click here.

     

    Breast implant saves a life

    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