Silicone gel filled breast implants were introduced to the US in 1962, and after 50 years of use, they remain among the most scrutinized medical devices currently available in the US. In June, 2011, the FDA released their Update on the Safety of Silicone Gel-Filled Breast Implants.
A Brief History of Breast Implants
1962 – Silicone gel-filled breast implants were introduced in the US. Prior to 1962, breast augmentation was performed with fat grafting or polyvinyl sponges.
1976 – US Congress passes the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Breast implants are classified as moderate risk (Class II) devices and required to comply with general controls and performance standards. The FDA reviews new breast implants through the 510(k) premarket notification process.
1980′s – Concerns are raised about associations between breast implants, particularly the silicone gel filled breast implants, and serious health issues such as breast cancer and systemic connective tissue disorders such as lupus, scleroderma and rheumatoid arthritis. The FDA reclassifies breast implants into Class III, higher-risk products needing premarket approval (PMA), and called for manufacturers to provide data demonstrating the devices were safe and effective.
1992 – The FDA decides that the manufacturers had not adequately addressed public concerns about certain complications. Rather than selecting the devices with a poor record, the FDA removes all silicone gel filled breast implants from the market, but only for elective cosmetic breast augmentation. The FDA continues to allow manufacturers to provide silicone gel filled implants for reconstruction after mastectomy, correction of congenital deformities, replacement of existing implants and for breast augmentation performed in conjunction with a breast lift. The Breast Implant Adjunct Studies were created, so that data could be collected about device performance and safety in these groups of women. In order to make breast implants again available for elective cosmetic breast augmentation, the FDA requires manufacturers to submit premarket approval applications that contained data on safety and effectiveness – like a new product. Europe follows the lead, but removes restrictions after 6 months, after reviewing the available literature and finding no links to serious systemic health issues.
1993 – The next generation of breast implants (Allergan Style 410 and Mentor Contour Profile Gel), textured, anatomic, highly cohesive (nearly form stable), silicone gel filled breast implants are complete, tested, and ready for submission for FDA studies in the United States and Europe … and Europe takes the lead.
1999 – The Institute of Medicine (IOM) releases a comprehensive report of the published literature and ongoing studies on breast implants, entitled Safety of Silicone Breast Implants. The study concludes that there is no evidence that silicone breast implants cause systemic health effects, such as cancer or autoimmune disease. Local complications (infection, bleeding, pain, deflation, capsular contracture, additional surgery) remain the primary safety issue with silicone breast implants.
2006 – The FDA approves Allergan’s Natrelle Silicone Gel Filled Breast Implants and Mentor’s MemoryGel Silicone Gel Filled Breast Implants. The FDA based its approvals on the manufacturers’ Core Studies. These clinical PMA studies followed hundreds of women with silicone gel filled breast implants for 4 years (Allergan) or 3 years (Mentor). The FDA determines that silicone filled breast implants are safe and effective and that the benefits and risks of breast implants were sufficiently well understood for women to make informed decisions about their use. As conditions of approval, the FDA requires both manufacturers to conduct six post-approval studies to investigate the long-term performance and safety of their silicone gel filled breast implants. From the FDA’s site these studies are:
Core Post-Approval Studies (Core Studies) – To assess long-term clinical performance of breast implants in women that enrolled in studies to support premarket approval applications. These studies were designed to follow women for 10 years after initial implantation.
Large Post-Approval Studies (Large Studies) – To assess long-term outcomes and identify rare adverse events by enrolling more than 40,000 silicone gel-filled breast implant patients and following them for 10-years.
Device Failure Studies (Failure Studies) – To further characterize the modes and causes of failure of explanted devices over a 10-year period.
Focus Group Studies – To improve the format and content of the patient labeling.
Annual Physician Informed Decision Survey (Informed Decision Study) – To monitor the process of how patient labeling is distributed to women considering silicone gel-filled breast implants.
Adjunct Studies – To provide performance and safety information about silicone gel-filled breast implants provided to U.S. women from 1992-2006, prior to approval, when implants could only be used for reconstruction and replacement of existing implants.
2011 – The FDA releases the Update on the Safety of Silicone Gel-Filled Breast Implants. The conclusion: breast implants, while not perfect, remain safe and effective. The most common problems associated with breast implants remain: capsular contracture, reoperation and implant removal (with or without replacement). Other frequent complications include: implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval, and there remains no apparent association between silicone gel filled breast implants and connective tissue disease, breast cancer, or reproductive problems.
What’s Next in US Breast Implants
A “new” breast implant has been available in Europe since 1993, and despite many years of experience, it continues to await US approval by the FDA. These from stable breast implants also are not perfect; however, they have a lower local complication rate than any breast implant currently available on the US market. San Francisco Bay Area Breast Augmentation patients and Plastic Surgeons alike, want to know, when will “gummi-bear” breast implants finally be approved? The date of approval remains anybody’s guess.
What follows is a video segment from my recent television appearance on the Bay Area’s Local News Station, KRON4. I was originally scheduled to talk about Tummy Tucks (Abdominoplasty), but we kicked off the show with this important late breaking news update for women with breast implants. The (415) phone number in the video was for the live broadcast only. If you have questions about abdominoplasty, feel free to call my office directly at (925) 943-6353, or use the contact format the bottom of the column to the left.
This ALCL (Anaplastic Large Cell Lymphoma) update video includes:
Information from the January 2011 FDA White Paper
Why is it called a lymphoma?
Why ALCL is not breast cancer?
What are the symptoms of ALCL?
How is the diagnosis of ALCL made?
How rare is ALCL (34 cases in 10 million breast augmentation patients)
How is ALCL treated?
Do my implants need to be removed?
The important points to keep in mind:
ALCL is very rare.
ALCL presents with symptoms.
increasing size
swelling
discomfort
fluid around the implant.
ALCL is not breast cancer.
ALCL treatment is available.
If you have concerns with your breast implants, seek advise from a Board Certified Plastic Surgeon in your area. If you have the symptoms above, don’t panic, it is still unlikely that ALCL is the cause, and your local Board Certified Plastic Surgeon can help.
I will get the rest of the show up shortly for all of you interested San Francisco Bay Area Tummy Tuck patients. Once the tummy tuck videos are uploaded, I will place links below. In the interim, if you have have questions, or would like to schedule a consultation, please give me a call at (925) 943-6353 or use the contact form on the left.
Yesterday, the FDA released a White Paper and Advisory Statement on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants. It is important that all patients and plastic surgeons understand the current state of knowledge surrounding this condition.
What Are My Chances of Getting ALCL if I Get Breast Implants?
This condition is incredibly rare. In fact, the known ALCL cases are too few to say conclusively that breast implants cause the disease. Efforts over the past 25 years by all the worlds major plastic surgery societies to raise awareness among members and to identify patients with ALCL have identified 34 unique cases worldwide among an estimated 10 million+ implanted devices. That’s about 1 in 300,000. To put this in perspective: the chance that you will get hit by lightning at some time during your lifetime is 1 in 6250. The chances are the same of you knowing 50 people who have been hit by lightning or one person with breast implant associated ALCL. On the other hand, the chance a developing a “real” breast cancer is 1 in 9.
So it’s Rare … but What if it Happens to Me?
As opposed to the systemic, nodal pattern of ALCL, in published reports, ALCL seen in the presence of breast implants has demonstrated an indolent course. In other words, it doesn’t spread. The women who developed ALCL, were cured with treatment. While ALCL seen in the presence of breast implants does fulfill the current WHO classification for ALCL, a form of Non-Hodgkins Lymphoma, the type of ALCL associated with breast implants potentially represents a distinct clinical entity. This condition is clearly NOT breast cancer.
Because of the extreme rarity of this condition, at this point no standard treatment has been determined. ALCL has been treated with everything from simple explantation (removal of the breast implant) and capsulectomy (removal of the scar around the breast implant) to aggressive systemic therapy. With either treatment, the condition was resolved.
Where Does the FDA Stand?
The FDA has not changed the status or availability of breast implants and has reaffirmed that the devices are safe and effective. In order to better understand this rare condition, the FDA has entered into an agreement with the American Society of Plastic Surgeons (ASPS) to create a registry for ALCL cases in the presence of breast implants. Until this registry is up and running, any clinical case will be reported directly to FDA. The FDA documents provide instructions for how to report any clinical cases to FDA. The American Society for Aesthetic Plastic Surgery fully supports the FDA and ASPS in this endeavor.
It’s Rare … But What Should I Look For?
Despite what you may have heard on the nightly news, the vast majority of breast implant patients will never have this problem. Moreover, most plastic surgeons will never see a single case in a lifetime of practice. The occurrence of ALCL with implants is so rare that routine screening of asymptomatic patients is not indicated; however, we all need to know what signs to look for.
The Presentation of ALCL with Breast Implants
This unusual tumor presents in two main ways:
A collection of fluid (a seroma) that develops well after breast implant placement
A mass involving the scar around a breast implant (the capsule)
Non specific findings: pain, lumps, swelling, or asymmetry, have also been associated with the above findings, and some cases have been associated with capsular contracture (firmness of the breast). If you think there is a problem, contact your Board Certified Plastic Surgeon today for follow-up.
ALCL Does Not Act Like Breast Cancer and There is More Good News
Knowledge is power. Raising awareness should be empowering and not frightening. Recent news reports on ALCL and breast implants seem a bit overblown; however, they do serve as a reminder that all women, with and without breast implants, need to be concerned about breast health. While ALCL is unlikely, the incidence of breast cancer is one in nine, and the vast majority of women who develop breast cancer do not have a family history of the disease.
The good news it that breast health is being discussed openly. I encourage you to do monthly breast exams, and to obtain routine mammography. The sooner a breast cancer is found, the easier it is to treat, and the better the quality of the life saved. Routine screening may seem a bother, but the life you save, will be yours to enjoy.
The ASAPS, the ASPS and Board Certified Plastic Surgeons around the world are all working together on this and other issues to keep cosmetic plastic surgery safe and predictable for everyone. For more information on ALCL and breast implants follow these links:
Cosmetic surgery of the breast encompasses many varied procedures. Breasts can be enlarged with breast implants via breast augmentation, or reduced in size with breast reduction or a reduction mammoplasty. If you are happy with the volume, but not the shape of your breast, a breast lift, or mastopexy, may help by lifting and firming the breast. Even problems with the size and shape of the nipple and areola can be addressed via breast enhancement surgery.
I recently had the opportunity to discuss the many aspects of cosmetic breast surgery, on KRON’s Body Beautiful. A portion of the show is dedicated to viewer questions, which are answered live on the air. Below is an excerpt from my interview with the Bay Area’s News Station’s Vicki Liviakis, which includes several interesting viewer questions. Please note, the 800 number in the video was used exclusively as part of the live show. If you have questions, or would like to schedule a consultation appointment, please call (925) 943-6353, or use the contact form on the left side of this page.
This breast augmentation video includes answers to viewers questions about:
When is it safe to replace breast implants to change size?
What problems can occur with breast augmentation to sizes larger than a D-cup?
Can breast size be matched to maintain proportions?
Is it safe have elective cosmetic surgery with diabetes or other medical illnesses?
Can breast implants really lift the breasts? (Click for additional information about Breast Augmentation Lift)
Finding the Right Breast Augmentation Surgeon
If you are considering breast augmentation, be certain to review the benefits, and the risks, with a Board Certified Plastic Surgeon like myself, as part of your breast augmentation consultation appointment. If you have developed problems with your breast implants, a consultation with a Board Certified Plastic Surgeon is the best first step toward finding relief.
Additional Information on Cosmetic Breast Enhancement
If you were peaking ahead, the preview screen on the video shows a side-by-side comparison of before and after pictures for breast reduction (reduction mammoplasty). I perform many different aesthetic breast enhancement surgeries. Sometimes reducing the volume and lifting the breasts is the best course of action. For patients with large breast and symptoms like lower neck and upper back pain, shoulder rutting from the bra straps and even recurrent rashes beneath the breasts, breast reduction surgery can provide an improved quality of life. It goes beyond being able to find clothes (and bras) that fit, but my patients are happy about that too.
Breast Reduction, Breast Augmentation and Breast Implant Revision Before and After Pictures
The 800 number in the video was used as part of the live show to allow viewers to have their questions answered by me, live, during the original broadcast. If you have questions, or would like to schedule a consultation appointment, please call (925) 943-6353, or use the contact form on the left side of this page.
Bay Area Breast Implants – Part 2 or 4
This cosmetic breast enhancement video includes information about:
Cosmetic breast enhancement including before and after pictures
I cannot emphasize this enough. If you are considering breast augmentation, be certain to review the benefits, and the risks, with a qualified Board Certified Plastic Surgeon, like myself. This is an important part of any breast augmentation consultation appointment. This is equally important if you have developed problems with your breast implants. A consultation with a Board Certified Plastic Surgeon is the best first step toward finding relief.
Additional Information on Cosmetic Breast Enhancement
Cosmetic breast surgery is an important facet of my Walnut Creek Cosmetic Plastic Surgery practice. San Francisco Bay Area Breast Augmentation patients, in particular, have come to expect a caring and professional approach to breast augmentation before, during and after surgery. I had the opportunity to discuss Breast Augmentation, and other aspects of cosmetic breast surgery, on KRON’s Body Beautiful earlier this month. Below is an excerpt from my interview with the Bay Area’s News Station’s Vicki Liviakis. The 800 number in the video was used as part of the live show. If you have questions, or would like to schedule a consultation appointment, please call (925) 943-6353, or use the contact form on the left side of this page.
This breast augmentation video includes information about:
Some common, and uncommon, questions about breast augmentation
Breast implant deflation and the treatment
Other topics listed in more detail below
Bay Area Breast Augmentation
When considering Breast Augmentation, it is important to consider breast implant selection, breast augmentation surgery and breast augmentation revision.
Bay Area Breast Implant Selection
Today’s breast implants now come with options. The size, shape and filler can all be varied. It is important to have a good idea of what you want out of your breast augmentation, so that the best options can be selected for you. The most important decision, is your desired size. The size of your breast implants will depend on the size you currently are, your body type and your desired goal size. More information is available in the San Francisco Plastic Surgery Blog regarding Breast Implant Options.
Bay Area Breast Augmentation Surgery
Options also exist regarding how to insert breast implants.
Incision placement
Periareolar – Around the lower border of the areola below the nipple
InfraMammary – In or just above the natural crease beneath the breasts
Axillary – in the armpit
Umbilical – TransUmbilcal Breast Augmentation (TUBA)
At some time in the future, your breast augmentation may require a tune-up. Breast augmentation revision surgery is one of my specialties. A common reason to revise breast augmentation is to change sizes. Most commonly, this is done to increase the size of the breast implants, but occasionally the implant volumes are reduced.
Breast implants can sometimes deflate, and may require replacement. Replacing a deflated breast implant is another common breast augmentation revision surgery. It also gives us the opportunity to make adjustments to the size, or other issues that may have been present before the deflation.
Breast implants tend to stay soft, but if capsular contracture occurs, the breast may become firm. Breast Augmentation Revision Surgery, like a capsulectomy or capsulotomy, can restore the softness to the breast. These types of procedures modify the scar that makes up the wall of the implants’ pocket. This scar serves an important roll in keeping the implant in its proper position. If the scar becomes tight, it can cause asymmetry.
Finding the Right Breast Augmentation Surgeon
If you are considering breast augmentation, be certain to review the benefits, and the risks, with a Board Certified Plastic Surgeon like myself, as part of your breast augmentation consultation appointment. If you have developed problems with your breast implants, a consultation with a Board Certified Plastic Surgeon is the best first step toward finding relief.
Additional Information on Cosmetic Breast Enhancement
Dr. Joseph Mele appears on KRON4's Body Beautiful.
To celebrate the debut of the new San Francisco Breast dot com (SanFranciscoBreast.com), a site dedicated to cosmetic breast surgery for the San Francisco Bay Area, I will be dedicating my appearance on Monday’s Body Beautiful on KRON4 to the breast. Breast augmentation, breast lifts, breast reductions, breast implant revisions, everything related to enhancing the breasts is open for discussion.
Body Beautiful is broadcast live at 11:00 AM on KRON4, so tune in and phone in with your breast questions. Whether you have had breast surgery, or are considering it, the show will cover a variety of topics. For a preview of what’s in store visit SanFranciscoBreast.com.
What’s new in Breast Enhancement Surgery?
The new web site is a comprehensive and authoritative review of the latest techniques in aesthetic breast surgery. Located in the San Francisco East Bay Area city of Walnut Creek, Plastic Surgeon, Joseph Mele, has lent his years of experience, and breast expertise, to this free patient education resource. The site is illustrated with graphics, videos and before and after pictures, and there is more to come. The list of topics covered is long and includes:
I look forward to hearing from you on Monday. If you will not be able to watch KRON4 at 11 AM on Monday, December 13, 2010, and you have a question you want answered, you can send your question via the contact form to the left. I will send you a personal response, and perhaps your question will be answered live during Body Beautiful.
San Francisco plastic surgery patients have an extensive new local resource encompassing all aspects of cosmetic breast enhancement surgery. I have consolidated my years of experience, and the common questions that my patients ask, to create a site that is both informative and understandable. If you are considering cosmetic breast surgery, SanFranciscoBreast.com is a comprehensive collection of consumer information.
The web site is illustrated with videos and before and after pictures. The list of topics covered is long and includes:
SanFranciscoBreast.com is a specialty site dedicated to all aspects cosmetic breast surgery. Since the site is focused only on the breast, it gives me the opportunity to describe each procedure in detail, and to provide you with specific information to help you make an informed decision.
What happens when a breast implant leaks, depends on the type of breast implant. When the breast implants are saline filled, the saline is water with 0.9% salt (NaCl). A small defect in the shell, or leak at the valve, will allow the saline to quickly escape. Since saline has the same saltiness as our body, the fluid causes no harm. There is no reaction to the leaking saline, and it is quickly absorbed. The leaking saline breast implant will deflate, and it becomes quickly obvious that there is a problem. No additional tests are usually necessary, and under most circumstances, arrangements are made to replace the defective breast implant; the sooner the better. Did you know that breast implants come with warranties?
Silicone gel filled breast implants give a different result. Silicone gel is cohesive (sticky) and tends to stay together. Because of this, it is possible to have a “silent leak” with silicone breast implants. A silent leak is when the implant has leaked, but there is no evidence of the problem on physical examination. The silicone gel can leak out of the implant, but continues to be contained by the capsule, the thin scar that forms around the implant that helps keep the implant from moving. Saline is absorbed by the scar, so a silent leak is not possible with saline implants.
If the silicone gel gets outside the scar, the body will try to contain it by forming additional scar. This can lead to lumps in the breast. To avoid this complication, the FDA has recommended that women with silicone gel filled breast implants get an MRI three years after surgery, and then every two years thereafter. The hope is that a leak can be detected in the silent stage, and treated (replaced) before the gel escapes the capsule and begins to form more scar tissue in the breast.
In addition to breast augmentation mastopexy, this video discusses breast implant leaks and breast implant replacement surgery. Combining breast augmentation with other surgeries is also reviewed. The two most common combinations breast lift with breast implants and breast augmentation and tummy tuck (the mommy makeover) are mentioned.
This is segment three of four from a recent airing of KRON’s Body Beautiful with Vicki Liviakis. The 800 number shown was for the live broadcast, so if you have questions please call my office directly at (925) 943-6353, or use the contact form to the left. Additional information can also be obtained from the links at the end of this article.
This episode includes:
Breast Augmentation vs. Breast Lift or the combination Augmentation Mastopexy.
How soon should a Breast Implant deflation be treated?
What is the recovery after Breast Implant replacement for deflation or size change?
Is leaking saline dangerous?
Is it a good idea to bring my friend, boyfriend or husband to the consultation appointment?
Why would I need a Breast Lift with my Breast Augmentation?
Can Breast Augmentation be safely combined with other surgery? Mommy makeover?
What are the indications for Breast Reduction surgery?
If you are interested in learning what specific treatment will work best for you, a personal consultation appointment is the way to find out. A Board Certified Plastic Surgeon can help define your goals and tailor the treatment to best achieve the results you desire. To schedule your consultation, please call (925) 943-6353.
Additional information on Breast Augmentation and Breast Lifts can be found here:
Breast implant warranties vary by manufacturer and by implant. In the United States, Allergan and Mentor are the two FDA approved breast implant manufacturers. Their implants are essentially the same, and they have been known to match each others warranties when changes are made. Below are the details of the warranties for 2010.
Allergan’s Natrelle® Breast Implant Warranty
Allergan markets their breast implants under the brand Natrelle®
Allergan’s breast implants are sold under the brand name Natrelle®. Every implant, saline or silicone gel, comes with the ConfidencePlus® warranty, and there is the option to buy the enhanced ConfidencePlus® Premier warranty.
The ConfidencePlus® warranty is free with the purchase of your Natrelle® breast implants, and it includes:
Free lifetime product replacement
Financial assistance of $1200 to defray the costs of surgery to replace the implant for 10 years after surgery
Non-cancelable terms
Enrollment Fee = Free
The ConfidencePlus® Premier warranty is $100 with the purchase of your Natrelle® breast implants, and it includes:
Free lifetime product replacement
Financial assistance of $2400 to defray the costs of surgery to replace the implant for 10 years after surgery
Non-cancelable terms
Implant replacement on the opposite (non-deflated) side for 10 years after surgery
Enrollment Fee = $100
Through 2010 (EDIT – extended through 12/312011), breast augmentation patients receiving Natrelle Silicone Gel implants will get the ConfidencePlus® Premier warranty for free. As an added bonus, the financial assistance of $2400 to defray the costs of surgery, will also be increased to $3500 for 10 years after surgery.
Warranties are changed frequently, so be certain to get the latest information direct from Allergan (<-click here).
Mentor’s Saline and Memory Gel Warranty
Mentor markets their silicone gel implants under the name MemoryGel®
Like Allergan, Mentor too has different warranties for different implants. Here are the Mentor Breast Implant Warranty details:
The Mentor Standard Advantage warranty is free with the purchase of your Mentor breast implants, and it includes:
Free lifetime product replacement
Financial assistance of $1200 to defray the costs of surgery to replace the implant for 10 years after surgery
Non-cancelable terms
Implant replacement on the opposite (non-deflated) side for 10 years after surgery
Enrollment Fee = Free
The Optional Mentor Enhanced Advantage warranty is $100 with the purchase of your Mentor breast implants, and it includes:
Free lifetime product replacement
Financial assistance of $2400 to defray the costs of surgery to replace the implant for 10 years after surgery
Non-cancelable terms
Implant replacement on the opposite (non-deflated) side for 10 years after surgery
Enrollment Fee = Free
Through 2010, breast augmentation patients receiving Mentor Memory Gel implants will get the Premier Advantage Limited Warranty for free. Like Allergan financial assistance of $2400 to defray the costs of surgery, will also be increased to $3500 for 10 years after surgery.
Since the warranty details do change, be certain to check for the latest directly from Mentor (<- click here).
