Earlier this year, the San Francisco Plastic Surgery Blog reported an extremely unusual, but possible association between breast implants and a rare form of Non-Hodgkin’s Lymphoma named Anaplastic Large Cell Lymphoma or ALCL. The tumor is extremely rare. Of the 5-10 million women with breast implants, fewer than 100 cases have been identified. Literature reviews have identified 34 unique cases, and as many as 75 cases may have been identified worldwide. Because of the rare nature of the tumor, it is not clear what the association between ALCL and breast implant is.
Anaplastic Large Cell Lymphoma
Demographics of all Known Reported Cases
Demographics of the cases are as follows:
Age: Median 51 years old, Range 28-87 years old
Implant Type: Silicone 24, Saline 7, Not specified 3
Time from implant to ALCL diagnosis: Median 8 years, Range 1-23 years
Reason for Breast Implant: Reconstruction 11, Cosmetic 19, Not Specified 4
The American Society of Plastic Surgery (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) have partnered with other international plastic surgery societies like the International Society for Aesthetic Plastic Surgery (ISAPS), to provide an organized way to report, and characterize the diagnosis and treatment of ALCL since its discovery.
ALCL is Not Breast Cancer
Breast cancer dwarfs ALCL in both numbers of cases and lethality. Breast cancer has an incidence of 1 in 9 women. This means for a group of nine randomly selected women, one woman would be expected to develop breast cancer in her lifetime. The actual breast cancer rate is a little higher, and this is why routine mammograms after age 40 are so important for early detection. The risk of getting breast cancer is about 700 times higher than the risk of getting struck by lightning.
No Increased Rate of Breast Cancer for Women with Breast Implants
While the association between ALCL and breast implants is still being worked out, there is no increased risk of breast cancer in women with breast implants. In fact, the results of more than seven long-term follow-up studies show that women with implants have a lower rate of breast cancer than is expected in the general population, and higher survival rates, perhaps due to enhanced breast awareness and early detection.
Looks Like ALCL, but Doesn’t Act Like ALCL
ALCL associated with breast implants is not as aggressive as other types of ALCL. It acts more like cutaneous lymphomas than the more systemic form of ALCL. ALCL associated with breast implants has been characterized as a rarely occurring, low-grade lymphoma, that seems to grow slowly and locally. While the risk of breast cancer is 1 in 9, the risk of ALCL is less than 1 in 300,000, and most resources quote ranges of 1 in 500,000 to 1 in a million. The risk of getting ALCL associated with breast implants is 50 to 150 times lower than the risk of getting stuck by lightning.
Last week, news of the first reported death from ALCL associated with breast implants hit the French news. The details are not known at this time, and unfortunately, the case is further complicated by the use of fraudulent breast implants that were filled with industrial grade silicone instead of the required medical grade silicone. The implants were manufactured by Poly Implant Prothèses (PIP) at La Seybe-sur-Mer in the Var. The company was forced to close in March of 2010, after it was determined that the implants were filled with non-medical grade silicone gel. These implants have more gel bleed, and are ten times more likely to break. Even though the company was forced to withdraw its products from the market when the discovery was made, thousands of French women are known to still have the defective implants. These implants have never been FDA approved in the US. Only Allergan’s Natrelle and Mentor’s Memory Gel breast implants are currently FDA approved.
The Latest ALCL News
The best information currently available on the topic is a review of opinions by a panel of experts from RAND Health, UCLA’s department of medicine’s division of hematology-oncology, the University of Michigan Health System’s department of surgery’s division of plastic surgery and others. The article has been accepted by ASPS’s Plastic and Reconstructive Surgery Journal, but has not yet been published. The results are based on the small number of cases known to exist, represent the opinions of the seven panel members and are not based on prospective randomized evidence. A copy of the article can be found here. The article’s disclaimer reads: Support for this study was provided by the Plastic Surgery Educational Foundation (PSEF) and the Aesthetic Surgery Education and Research Foundation (ASERF) through unrestricted grants from Allergan, L.L.C.; Mentor Worldwide, L.L.C.; and Sientra, Inc. Neither the study sponsors nor the listed companies had roles in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
As more information becomes available, I will post more updates. It is important to remember that this is an extremely rare problem. It is a sensational story though, so it is sure to hit the mainstream media soon. The ASPS, ASAPS and ISAPS are actively seeking all known cases of ALCL found around breast implants to determine what, if any association exists, if there is a causal relationship and how best to treat the disease when discovered. If you have, or know someone who has, ALCL associated with breast implants, please contact one of these plastic surgery societies and the FDA.
More Information About ALCL
A current summery of ALCL cases appeared in the June issue of Plastic and Reconstructive Surgery. The abstract can be read here.
The FDA has an ALCL and breast implants FAQ page here. Moreover, all confirmed cases of ALCL in women with breast implants should be reported to Medwatch, the FDA’s safety information and adverse event reporting program. Report online here or by calling 1-800-332-1088.
How to Detect ALCL Associated with Breast Implants
The chances of getting breast implant associated ALCL are extremely remote. I have thousands of patients with breast implants, and chances are that I will go my entire career without seeing one case. This, however, will not keep me from looking for it.
Most cases of ALCL in patients with breast implants have presented with a seroma (fluid collection) around the breast implant more than six months after the initial surgery. To try and detect ALCL as soon as possible, experts are recommending aspirating (draining) seromas around breast implants when they occur later than six months after breast augmentation or breast augmentation revision surgery, and also sending the fluid for cytologic analysis to check for abnormal cells. If you feel you have a problem with your breast implants, do not delay; seek the advice of a Board Certified Plastic Surgeon in your area.
On April 12, 1961, Soviet cosmonaut, Yuri Gagarin, used a space capsule like this to become the first human in orbit. That same year, the first breast implant was developed by American plastic surgeons Thomas Cronin and Frank Gerow.
Breast implant capsules have a bad reputation. Normally, they are only discussed when they are causing problems like capsular contracture or breast implant malposition. However, like a space capsule, the breast implant capsule provides protection, and without breast implant capsules, there would be no breast augmentation.
What is a breast implant capsule?
Whenever a breast implant is used for breast augmentation, your body makes an encapsulating sheet of scar that lines the breast implant’s pocket. This normally thin, soft scar is called the “capsule”, and it is incredibly important in maintaining your breasts’ enhancement.
Have you ever wondered how breast implants stay in place?
The capsule is responsible for keeping the breast implants in the proper position beneath the breasts. It forms in just a few weeks after breast augmentation surgery and keeps the breast implants from freely sliding around. Optimal breast implant position is a combination of careful placement during surgery and a proper capsule. The capsule will quickly line the surgical pocket and provide a smooth, strong interface between the breast implant and the soft tissues of the chest. By reinforcing the pocket, the capsule helps to maintain optimal breast implant placement.
The capsule protects the breast implant.
Not only does the capsule help keep the breast implant in position, it also protects the implant. The interior of the capsule is smooth and allows for nearly frictionless movement within its boundaries. The outer layers of the capsule provide enhanced vascular circulation and helps protect the breast implant from infection.
When good capsules go bad.
So what can go wrong with breast implant capsules? The perfect capsule is firm enough to maintain proper breast implant positioning, but soft enough to not be felt. Problems occur at the extremes, so like Goldilocks the capsule needs to be just right, not too hard and not too soft.
Too soft
When the Breast Implant Capsule is too soft, it does not provide enough support for the implant. Gravity pulls the implants down when standing or to the side when laying down. The larger the breast implants, the greater the force. Stomach sleeping also pushes the implants apart. A healthy capsule can resist the tendency toward Breast Implant Malposition, but a good bra helps too.
Treatment for implant malposition can include a capsulorrhaphy, to tighten the capsule, and close off the areas where the implant should not be going. If an overly large breast implant in compounding the problem, a smaller implant can help reduce recurrence. The use of an acellular dermal matrix (ADM) has also become more popular as a way to line, reinforce and thicken the capsule.
Too hard
When the Breast Implant Capsule is too hard, it can compress the implants, and cause Capsular Contracture. Capsular contracture can also result in breast implant malposition. If the capsule is tight only on one side, it will push the breast implant toward the soft side. If the capsule is tight all the way around, it can make the implant feel hard.
Treatment for capsular contracture includes capsulectomy, removing the thickened capsule, and capsulotomy, incising the capsule to allow it to expand. Both these techniques are performed in the operating room. An older, non-operative technique called closed capsulotomy was a way to split the capsule without surgery by forcefully compressing the implant. This has been largely abandoned as it has less predictable results, may lead to uncontrolled bleeding or implant rupture, and violates most breast implant warranties.
Just Right
The most common types of capsules are grade I followed by grade II. Grade I capsules are soft on not detectable from the outside, Grade II capsules feel firmer, but are not tight enough to cause visual changes. Both usually provide adequate support to allow the breast to age naturally, securely on the chest. If you are considering breast augmentation, or you have breast implants and are considering breast implant revision surgery, give me a call at (925) 943-6353 or contact my Walnut Creek Plastic Surgery Office using the contact form in the left column.
Breast Implant Revision Surgery is performed to improve the results of Breast Augmentation. While Breast Augmentation is both safe and effective, our bodies continue to change as we age. Breasts naturally change size and shape over time. This occurs with or without breast augmentation. While most changes are gradual, changes can happen relatively quickly with pregnancy and changes in weight.
Breast Implant Replacement
Breast implants can wear out too, requiring a new implant to be placed. The major US breast implant companies, Allegan and Mentor, do provide Breast Implant Warranties.
What Are the Common Reasons for Breast Augmentation Revision Surgery?
The most common reasons for Breast Implant Revision Surgery are a desire for a change in size, deflation of the breast implant, capsular contracture and breast implant malposition. It is important to clearly identify what problem(s) are bothersome, and to seek a consultation with a Board Certified Plastic Surgeon.
Below is number four of four of my latest Breast Implant Revision Videos. They appeared on KRON4′s Body Beautiful. The series covers Breast Augmentation, Breast Implants and Breast Augmentation Maintenance. The television show was broadcast live, so viewers could call in during the broadcast to have their questions answered. The (415) number shown in the video was only for the show; however, if you have Breast Augmentation or Breast Implant Revision questions, please call our San Francisco Bay Area Plastic Surgery Office directly at (925) 943-6353. If you prefer, you may also use the contact form on the left.
San Francisco Bay Area Breast Implant & Breast Augmentation Revision Video
San Francisco Bay Area Breast Implant Revision Questions
This Breast Augmentation and Breast Implant Revision Surgery video includes:
The type of trauma most likely to cause breast implant deflation
Common reasons for breast implant revision surgery
Changing breast implant size
Breast implant leaks
Capsular Contracture
Breast Implant Malposition
Breast Augmentation and Breast Implants Revision Resources
You are viewing number three of four Breast Implants Revision Video segments from Dr. Mele’s recent Body Beautiful television appearance. Here are links to the other segments:
Breast Augmentation remains one of the procedures that I perform most frequently. Whether you’ve always had small breast and want them larger, or you had larger breast and want them back, Breast Augmentation can help you achieve your goals.
Breast Implant Revision Surgery is performed to improve the results of Breast Augmentation. While Breast Augmentation is both safe and effective, our bodies change as we age. Breasts naturally change size and shape over time, and this happens even after breast augmentation. Changes can certainly be exacerbate by pregnancy and changes in weight, but most of the time the changes are gradual and sneak-up on us.
What’s New in Breast Implants and Breast Augmentation?
If you are considering Breast Augmentation or Breast Implant Revision surgery, you should know that new breast implants are available and more are on the horizon. New techniques are also being developed to help make your Breast Enhancement simpler, safer, more predictable and easier overall. Be certain to seek a Board Certified Plastic Surgeon for all your Cosmetic Breast Surgery needs.
Below is part three of four of my Breast Implant Revision Video that appeared on KRON4′s Body Beautiful. Options in Breast Augmentation, Breast Implants and Breast Augmentation Maintenance are reviewed. The television show was broadcast live, so viewers could call in during the broadcast to have their questions answered. The (415) number shown in the video was only for the show; however, if you have Breast Augmentation or Breast Implant Revision questions, please call our San Francisco Bay Area Plastic Surgery Office directly at (925) 943-6353. If you prefer, you may also use the contact form on the left.
San Francisco Bay Area Breast Implant & Breast Augmentation Revision Video
San Francisco Bay Area Breast Implant Revision Questions
This Breast Augmentation, Breast Implant Revision Surgery video includes:
The Breast Implants currently available
Saline Breast Implants – Natrelle (Allergan) and Mentor (J&J)
Silicone Gel Breast Implants (Natrelle and Memory-Gel)
Soft-Solid Silicone Breast Implants (GummiBear Implants)
Natrelle 410′s*
Mentor Contour Profile Gel (CPG)*
*The 3 yr and 5 yr data for the 410′s and CPG breast implants surpasses that of the breast implants that are already approved in this country. Why are they not approved? Only your FDA knows for sure.
Breast implant deflation
What are the signs and symptoms associated with a leaking breast implant?
How to check for a breast implant leak
How long do Breast implants last?
How are breast augmentation and breast lifts combined?
Breast Augmentation and Breast Implants Revision Resources
You are viewing number three of four Breast Implants Revision Video segments from Dr. Mele’s recent Body Beautiful television appearance. Here are links to the other segments:
Breast Implant Revision Surgery is performed to improve the results of Breast Augmentation. Breast Augmentation Revision can help with Breast Implants are the wrong size, in the wrong position, have developed capsular contracture or when other cosmetic deformities require correction. Specific techniques have evolved for the correction of the most common problems that can occur with Breast Implants. Some recently developed new techniques have significantly improved the results of breast implant revision for problems that have been difficult in the recent past.
San Francisco Bay Area Breast Augmentation
This segment of Body Beautiful focuses on before and after results. Breast Augmentation is reviewed, as well as the correction of specific breast implant problems like capsular contracture and implant malposition (bottoming out and symmastia). The following Breast Implant Revision Video was broadcast on KRON4′s live Medical Monday show, Body Beautiful. The television show allows viewers to call in during the broadcast and have their questions answered. The (415) number shown in the video was only for the show, so if you have Breast Augmentation or Breast Implant Revision questions, please call our San Francisco Bay Area Plastic Surgery office directly at (925) 943-6353, or use the contact form on the left.
San Francisco Bay Area Breast Augmentation & Breast Implant Revision Video
San Francisco Bay Area Breast Implant Revision Questions
This Breast Augmentation, Breast Augmentation Revision Surgery video includes:
Before and After Pictures of Breast Augmentation
Before and After Pictures of Breast Augmentation Revision including:
Before and After Pictures of Breast Augmentation Revision for a Breast Implant that is too low and a poorly formed inframammary fold (IMF)
Before and After Pictures of Breast Augmentation Revision for Grade III Capsular Contracture causing the Breast Implant to be too high (Capsulotomy/Capsulectomy)
Before and After Pictures of Breast Augmentation Revision for Grade IV Capsular Contracture causing the implant to ride up and appear significantly smaller
Before and After Pictures of Breast Augmentation Revision for Breast Implants that are too close (as seen in symmastia) and too far from the midline (often causing a large gap between the breast implants) and rippling on the inside of the breast (medial rippling)
Before and After Pictures of Breast Augmentation Revision for severe bottoming out with internal capsulorrhaphy (though a breast lift is the most frequently selected option)
Breast Augmentation and Breast Implants Revision Resources
You are viewing part two of four Breast Implants Revision Video segments from Dr. Mele’s recent Body Beautiful television appearance. Here are links to the additional segments:
Breast Augmentation remains one of the most popular cosmetic plastic surgery procedures. While often the procedure lasts a lifetime, breast augmentation revision is quite common. Breast Implant Revision has emerged as a specialty unto itself. While many of the tenants that lead to excellent Breast Augmentation results will also apply to Breast Augmentation Revision, new and specific techniques have evolved for the correction of the common problems that can occur with Breast Implants.
The most frequent reasons for Breast Augmentation Revision Surgery include the desire to change the size of the breast, breast implant deflation, problems with the position of the breast implants and tightening of the scar that normally forms around the breast. The last listed is called capsular contracture.
San Francisco Bay Area Breast Augmentation
What follows is a Breast Implant Revision Video segment from KRON4′s live Medical Monday show, Body Beautiful. The television broadcast allows viewers to call in and have their questions answered live. The (415) number shown in the video was only for the show, so if you have Breast Augmentation or Breast Implant Revision questions, please call our San Francisco Bay Area Plastic Surgery office directly at (925) 943-6353, or use the contact form on the left.
San Francisco Bay Area Breast Augmentation & Breast Implant Revision Video
San Francisco Bay Area Breast Implant Questions
This Breast Augmentation, Breast Augmentation Revision Surgery video includes:
What to consider before having Breast Augmentation
Is “routine maintenance” for Breast Implants required?
If my Breast Implants are too high, can they be lowered?
If my Breast Implants are too low, can they be raised?
If my Breast Implants are too wide, can they be moved towards the middle?
If my Breast Implants are too close together, can they be separated?
What causes Breast Implants to fail?
Can I maintain my body proportions and have Breast Augmentation?
What are the problems associated with Breast Implants which are too big?
Breast Augmentation and Breast Implants Revision Resources
You are viewing one of four Breast Implants Revision Video segments from Dr. Mele’s recent Body Beautiful television appearance. Here are links to the additional segments:
Breast Augmentation and Breast Implant Revision San Francisco Bay Area – 1 of 4 (You Are Here)
This patient had breast augmentation prior to becoming pregnant. Left: After pregnancy, the breast implant position remains unchanged; however, the breasts have dropped. Right: After breast augmentation revision, the breasts have been lifted and the breast implants exchanged, dramatically improving the breasts' shape and profile.
Pregnancy and Breast Augmentation
Pregnancy can change the volume and shape of breasts, and the result isn’t always positive. If you have been pregnant, you know firsthand. For the lucky few the changes are subtle, or even enhancing, but usually they are not. Many patients opt for breast augmentation after having children to restore what was lost. If you are trying to get pregnant, it is worth delaying your breast augmentation; however, if childbearing is not imminent, waiting may not be desirable.
Breast Implant Problems After Pregnancy
The breast augmentation revision before and after pictures above are of a woman who had breast augmentation at a young age, and enjoyed her breast implants for many years. After childbearing, her breast implants remained in a perky position, but the natural breast tissue sagged. Her breasts would have sagged and deflated whether she had breast implants or not, but with implants the result was normal elongated, deflated breasts, with the addition of disproportionate upper pole fullness from her breast implants.
The Breast Implant Revision Solution
The solution was a breast lift with breast implant exchange. The natural breast tissue was lifted to reduce the length of the breast and firm the natural breast tissue. The breast implant was exchanged to help with both shape and the post-partum changes in breast volume. Larger breast implants can be used to replace lost breast volume. Smaller implants, removal of the breast implants, or even breast reduction can help when the breast remain too large after lactation.
A desire to change breast implant size (larger or smaller)
Deflation of the breast implant
Firmness due to tightening on the breast implant capsule (capsular contracture)
Breast implant asymmetry or malposition like bottoming out, double bubble or symmastia (uniboob)
If you have one of these problems, a Board Certified Plastic Surgeon, like Walnut Creek Breast Implant Specialist Joseph Mele, MD, FACS, can help.
Tomorrow, Dr. Mele will be appearing on Body Beautiful. The show airs live on KRON, channel 4, September 12, 2011, at 11:00 AM. Breast augmentation and breast augmentation revision surgery will be discussed. If you have questions, call in to the KRON studios on Monday at 11:00AM, or send us your question through the contact form on the left. Every effort will be made to answer your questions during the show.
Breast Implant Revision Videos
Below are links to previous television appearances on KRON4 featuring Breast Augmentation Revision Videos and Breast Augmentation Revision Before and After Photos:
Breast Augmentation Scar Revision Before and After Pictures
Breast Augmentation Scar revision is another reason for Breast Implant Revision Surgery. Follow the link for a case presentation of breast augmentation scar revision for a wide-spread periareolar scar : Hypertrophic Breast Scar Revision
Capsular Contracture occurs when the scar that normally forms around a breast implant becomes too much scar. It is normal and desirable that a scar forms around the breast implant. The scar forms a pocket called the capsule. The capsule secures the breast implant and keeps it from migrating around under the skin. The capsule is very important to prevent malposition and bottoming-out of the breast implants. A normal capsule is soft and cannot usually be felt.
What is Capsular Contracture?
Capsular Contracture occurs when the capsule is too tight or too thick. While Wikipedia defines capsular contracture as an abnormal response of the immune system, it is more likely an exaggerated normal response. If the capsule is tight all around the breast implant, it can make the breasts feel hard and immobile. If the capsule is tight on just one side, it can push the implant. For example, when the scar is tight on the bottom, it moves the implant up. The result is the opposite of bottoming out.
Baker’s Grades of Capsular Contracture
Capsular Contracture is graded (Baker grades) as follows:
Grade I – Naturally soft. Not palpable
Grade II – Increased firmness. Scar is palpable. No visual distortion.
Grade III – Firm to touch. Immobile causing visual distortion.
Grade IV – Same as Grade III and painful.
Grades I and II are the most frequently seen capsular contractures and are not normally treated. Grades III and IV are less frequent, and are often treated with a Breast Augmentation Revision Surgery.
Capsular Contracture Treatment
Many non-operative treatments exist and none have been proven to be clinically effective. Massage, ultrasound, vitamin-E, antibiotics, steroids and the latest leukotriene inhibitors (Accolate) have been tried with occasional anecdotal improvement, but there are no large studies proving any of these techniques safe and effective for treating capsular contracture. They are frequently employed with grade II and early grade III capsular contracture in an attempt to reverse the progression to a tighter scar capsule.
The best method of treatment remains breast implant revision surgery. For grade III and IV capsular contractures, capsulotomy and capsulectomy are the mainstay of treatment. Capsulotomy is a surgical technique during which the capsule is incised to allow for expansion. This is most effective when the scar is thin and soft. Capsulectomy is the surgical removal of the scar. This is used when the scar is thick. There is a slightly greater risk of bleeding with the capsulectomy.
More Information about Capsular Contracture is Available Here
Additional articles about Capsular Contracture are available here on the San Francisco Plastic Surgery Blog. Just click these links:
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.
