November 30th, 2013 Miguel A. Delgado Jr, MD
San Francisco, CA-Silicone breast implants were reintroduced in 2006 after a moratorium by the FDA removed them from the market in 1992. It was believed that silicone implants may have been causing autoimmune diseases. After many years of clinical trials, it was determined that silicone implants were safe, and once again manufacturers made them available for breast augmentation surgery to women 22 years of age and older. The FDA recommends that women have an MRI periodically to check for a possible “silent leak”.
Allergan’s Natrelle, which is a cohesive implant, was approved in February 2013, and Sientra has a cohesive implant that was approved in March 2012. Mentor is the only breast implant company that manufactures their implants in the United States, but the other companies follow the same strict guidelines.
Mentor is the manufacturer of “MemoryShape” a highly cohesive breast implant, also known as the “gummy bear” implant. The implants firmness and gel consistency are similar to the “gummy bear “candy. Even though it has been available for 10 years in 70 countries, it has only just been approved by the FDA as of June 2013 and now is available in the United States. It has been in great demand, and Dr. Delgado is happy to announce that it is now being offered to his patients.
MemoryShape implants have a natural teardrop shape, which are thinner at the top and gently slope to a fuller projection at the bottom. The implants have a textured design which helps keep the implants in position.
Some of the advantages of these new implants that are appealing to women are; the firmer, perkier look plus the implants are less likely to ripple, leak through the breast tissue or rupture. The downside is that some more mature women do not want the firmer implants, preferring the softer more natural feel and look that the standard gel implants give.
All of the cohesive gel implants vary in shape, firmness and dimensions. Due to their anatomical shape, all manufacturers have used textured shells to help keep the implants from rotating. Breast implant companies have their own specifications as to how cohesive their implants are and how much gel is placed in them, so there is varying degrees to the firmness.
Predicting that the FDA would approve silicone implants once again, manufacturers began clinical trials with different types of silicone implants, in particular the cohesive gel implants in 2001. Clinical trials are still ongoing today, but getting needed feedback from patients and surgeons is extremely challenging as many woman who are satisfied with their surgery do not return for their follow up visits.
Breast augmentation remains the number one cosmetic procedure for women in the United States, with over 286,000 performed in 2012 according to the American Society of Plastic Surgeons. It is unknown how many breast enhancement procedures are done around the world, but the popularity is such that manufacturers are extremely competitive in trying to grab the majority of the market share. Each company has its own philosophy regarding the amount of cohesiveness, anatomical shape, dimensions, and design of the shell. It is recommended that women seek out a Board Certified Plastic Surgeon that specializes in breast surgery to help them make a decision as to which breast implant is best. For a woman to try to make this decision on her own would be daunting.
In addition to the new implants, Dr. Delgado continues to bring the latest innovative cosmetic treatments to his patients which includes CoolSculpting, a non-invasive treatment for reducing pockets of fat mainly for the abdomen, waist and hips. For men an additional area could be for their chest if they suffer from pseudo-gynecomastia which is man boobs caused by fat. The other new treatment available at the “Non-surgical Center of Excellence” is Ultherapy an exciting non-surgical tightening of skin for the face and neck. Schedule a consultation with Dr. Delgado to find out what options may be of benefit to you by calling (415) 898-4161 or email.
July 31st, 2013 Miguel A. Delgado Jr, MD
Marin, California – This is a 55-year-old, female resident of Marin, California who presented to the Novato office for evaluation for revisional breast surgery. She underwent bilateral silicone breast implants in 1975. She developed bilateral ruptures of both implants and severe capsular contractures. She underwent removal of silicone material with subpectoral placement of 300 cc, Mentor silicone- gel breast implants. Her procedure was performed at Marin Cosmetic Surgery Center in Marin County, California.
San Francisco, CA-Manufacturers of breast implants all state that implants are not lifetime devices, however, most companies including Mentor give free replacement of qualifying devices that have failed, for the lifetime of the patient. Most companies offer additional monetary compensation to help defer the cost of breast revision surgery for up to ten years.
Statistics show that the percentage for failure of an implant is approximately 1% per year. At 10% probable failure rate at 10 years, the manufacturers no longer offer to help with cost of surgery for replacement. This statistic has caused confusion for many (see the previous blog dated July 15, 2013). This does not mean that implants must be replaced at the 10 year point. Some women will have issues with their implants much earlier and some much later and for a lucky few maybe never. You should assume that you will need a revision at least once in your life and very possibly within the first ten years. If you are not having any issues with your implants, you do not need to have them replaced, but you should keep current with your breast exams with your doctor. See breast implant pictures before and after revision of some of Dr. Delgado’s patients here.
It is interesting to note that many people use the terms rupture and deflation interchangeably. Some say rupture refers only to silicone implants, and deflation refers only to saline implants. The FDA states that the term rupture can refer to any type of breast implant, but deflation will only be used to describe saline breast implants.
Saline implants are filled after insertion during surgery by a valve that can fail at some point or leak. Silicone gel implants are pre- filled by the manufacturer, requiring a somewhat larger incision for insertion, but they have less probability of rupture.
Saline breast implants can deflate very quickly or slowly over a period of a few days. The deflation will be very evident to the patient as the breast will have lost volume looking like a flat tire or a deflated balloon. The saline that leaks into the body is harmless and will come out in your urine. It is not a medical emergency requiring replacement surgery immediately, but the sooner the better as the pocket will start to shrink, and scar tissue may set in making revision surgery more difficult.
Silicone gel implants prior to 1992 were filled with a gel that was more of the consistency of thick honey. If an implant were to rupture, the gooey gel could migrate to other parts of the body, making the removal of the implants a challenging and tedious procedure for breast revision specialists. Suspicious health problems were surfacing, and the FDA placed a moratorium on silicone implants until major improvements and studies were conducted. After many years of trials, in 2006 the FDA approved the new silicone implants that are made of a more cohesive gel.
With the approval of the new gel implants came a warning from the FDA. Besides only being available to women 22 years of age and older, the FDA recommends that women have a magnetic resonance imaging (MRI) of their breasts after 3 years of their original surgery, and then every 2 years after that, to monitor for “silent leaks”. Due to the costs involved for this test, which can range from $1,000 to $2,000 depending on what part of the country you are in, many women choose have a MRI only if they have issues. Keep in mind that a MRI is not a perfect science; false positives have been known to occur. Any concerns that you may have with your breasts should be brought to the attention of your plastic surgeon who will help you determine the best course of action.
Some causes for deflation of breast implants are:
• Capsular contracture, (the constricting formation of scar tissue around the implant)
• Mammogram, (be sure to inform your technician that you have implants)
• Implant age
• Overfilling/under filling of saline implants(beyond what the manufacturer recommends)
• Breast trauma (car accident, closed Capsulotomy)
• Non-FDA approved incision site (the belly button)
• Surgical instruments during surgery
• Defective valve of the saline implant
Even with the possibilities of future breast revision surgeries, breast augmentation for women in the United States was the most sought after of all cosmetic procedures in 2012, according to the American Society of Aesthetic Plastic Surgeons (ASAPS). ASAPS reported that there were over 330,000 breast augmentation procedures performed with 72% of women choosing silicone implants over saline.
July 15th, 2013 Miguel A. Delgado Jr, MD
San Francisco, Mentor Implants
San Francisco, CA-Breast augmentation has been the number one cosmetic surgical procedure since 2006, according to the American Society of Plastic Surgeons. The evolution of the breast implant has changed dramatically since it was first introduced about 50 years ago in the 1960’s.
The first generation of breast implants introduced was a Cronin-Gerow implant in 1963. It was a tear drop shaped implant filling a silicone rubber envelope with a viscous silicone gel.
The 1970’s brought the second generation of breast implants, which had a thinner shell and low cohesion silicone gel filler, improving the size, look and feel of the implant. The second generation implants proved to be fragile with high rates of rupture and “gel bleed” where the silicone actually leaked through the shell, causing increased incidents of medical complications.
In the second technological stage, a polyurethane foam coating was used on the implant to reduce the incidence of capsular contracture. The third technological development was the double lumen implant which as a silicone implant inside a saline implant but the complex design proved to have a greater failure rate than the single lumen implant.
The 1980’s brought the third and 4th generation of implants with continued advances in technology that further reduced gel bleed and increased the cohesive gel.
The mid 1990’s brought the fifth generation of silicone breast implants that were made of a semi-solid gel practically eliminating filler leakage, with improved safety and lower rates of capsular contracture and device shell rupture.
In 1992, the FDA placed a moratorium on silicone implants allowing only women needing breast reconstruction or breast revision surgery to have them until further studies could prove their safety.
The breast implant manufacturers conducted many clinical trials, and in 2006, the FDA lifted its restrictions on silicone implants for women 22 years of age and older. The FDA does recommend that women have periodic MRI screenings to rule out “silent leaks”.
The manufacturers give a lifetime warranty on their implants should they deflate or rupture due to a malfunction of the implant. If this should happen within 10 years of the implantation, the manufacturers also give some monetary compensation to the patient to help offset the breast implant costs of surgery. This warranty has caused some confusion for women as to the life of their implants. Some believe that, after 10 years, they must have their implants replaced. This is not the case.
Napa, California – A 35-year-old resident of Napa, California who presents to the Novato office in Marin County for breast revision surgery. Her initial breast augmentation was with 300cc normal saline implants and developed early breast contracture and mal-position on her.
It is true that breast implants are not lifetime devices and most women will have to have them replaced once and maybe more in their lifetime. As a general rule of thumb, 10 years is the average that women may need to have some type of revision surgery.
There are several different scenarios where a woman may need to have breast revision surgery, most commonly it may be a deflation or a rupture or capsular contracture. Sometimes revision is needed if the implant has shifted its position or a woman may desire to change the size of her implants. In addition, a need for revision could be the development of a “double bubble” where the implants rests below the natural crease of the breast or the implant has “bottomed out” where the nipple is sitting too high on the breast. Women’s breasts change after pregnancy and childbirth and/or with weight fluctuations causing many to need a breast lift. See before and after pictures of breast implant revision surgery cases of Dr. Delgado’s here.
Women who are not having complications do not need to have their implants replaced, and for some lucky women this may never happen. Women who are planning on having breast augmentation need to assume that they will need revision surgery at least once in their life. It is strongly recommended that women have periodic visits with their plastic surgeon to maintain the health of their breasts.
February 7th, 2011 Miguel A. Delgado Jr, MD
The Food and Drug Administration (FDA) released what they call a “white paper” on January 26, 2011. This is an advisory statement on Anaplastic Large Cell Lymphoma (ALCL) and a possible link for women with breast implants. ALCL is a non-Hodgkin lymphoma which is a rare cancer that can occur anywhere in the body, and even more rare to be found in the breasts.
The FDA identified 34 unique cases of ALCL in women with breast implants, in scientific literature from January 1, 1997 through May 21, 2010. This is out of about 10 million implanted devices. It is believed that the vast majority of California Bay Area plastic surgeons and plastic surgeons world wide, will never see a single case in a lifetime of practice. Most cases were discovered when women sought medical attention for; capsular contracture, lumps, pain or seromas around their breast implants. The cancer is usually inside the scar tissue of the capsule and is not considered breast cancer.
Recently there have been articles in several publications regarding a possible link between ALCL and breast implants, and there may be more articles to come. While it is important for women to be aware of the situation, there is no need for alarm. The FDA emphasizes this is not breast cancer. The FDA has published a safety communication so that health care providers and the public are informed of the possible association. They are not recommending that women that do not have symptoms or other abnormalities have their implants removed. They have not changed the availability or status of breast implants and have reaffirmed the safety and effectiveness of the devices when used as labeled.
The American Society of Plastic Surgeons (ASPS) and the FDA are establishing a registry to gather more information about ALCL for women with breast implants. Hopefully this information will put San Francisco and Bay area women’s minds at ease, however any questions or concerns, should be directed to their plastic surgeon.
December 6th, 2010 Miguel A. Delgado Jr, MD
The evolution of breast implants has changed significantly, for the better. Now plastic surgeons have more choices than ever before. One aspect in particular that I would like to discuss in this blog is the different round shape that we use for breast augmentation. The different shapes allow us to create a more natural looking breast and an implant that fits better within the breast pocket.
There are three round implants; a moderate profile breast implant, moderate plus breast implant, and a high profile breast implant. All three of these implants are round implants they come in both smooth and contour. As one goes from the moderate to the high profile implant, we take one size let’s say 300 cc’s, the look of each implant differs in its diameter. So the moderate silicone implant is flatter, the high density or high profile implant is higher with the same 300 cc volume. Please look at the illistration and you will see that these are the exact same volume but different projections with the implant. This allows us to sit the implant into the breast pocket for a snugger fit much like a foot is being fit into a shoe.
I have found great patient satisfaction with these breast implants. The ones I use for my San Francisco and Marin offices are Mentor implants, they come in both normal saline and silicone gel implants.