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.
March 30th, 2013 Miguel A. Delgado Jr, MD
Dr. Delgado has been using the Keller Funnel for his San Francisco Bay Area patients for quite some time now. Always wanting the best possible results for all of his cosmetic surgery patients, he is on top of all new procedures and devices.
The Keller Funnel was brought to market in August 2009. It is a device designed for easier insertion of silicone breast implants for cosmetic plastic surgeons performing breast augmentation surgery. Patients seem to heal faster and adjust to their implants easier.
The funnel is a nylon pouch shaped like an icing bag with an interior coating of a special lubricant, allowing any style or size implant up to 800cc’s to be inserted. The narrow end is placed into the incision, and the surgeon squeezes the implant into the breast. The traditional delivery system for augmentation mammoplasty, the surgeon uses his finger tip to guide the implant through the incision into the pocket.
The Keller funnel is a one use “no touch” disposable device. It allows the surgeon to make a smaller incision with less stress on the implant; in fact an independent study claims the method reduces force applied on an implant by 95%.
Another advantage of a “no touch” technique is that it greatly reduces possible contamination. The breast is not a sterile organ; there is colonized bacteria living in the nipple ducts. Even with proper surgical preparation there is no guarantee of a completely sterile surgical field. Bacterial contamination is believed to be one of the leading causes of capsular contracture.
December 27th, 2012 Miguel A. Delgado Jr, MD
Before and After Breast Revision Surgery
Any foreign material implanted in the body will develop a tissue capsule around it. This includes breast implants, artificial joints and pacemakers. This is a normal part of the healing process and usually does not cause a problem. For 15% to 20% of women who have breast augmentation, the capsule can thicken which will constrict the implant and make it feel hard requiring breast implant revision.
San Francisco Bay Area women ask what can be done if a capsular contracture should form causing discomfort and distortion of one or both breasts. There are two different techniques used to release the capsule.
The Capsulotomy is the least aggressive procedure. The surgeon makes several incisions usually at the base of the breast capsule. The capsule is not removed, just cut in several places allowing the capsule to expand.
The Capsulectomy is a more involved procedure, where the surgeon removes the entire capsule; the Capsulectomy generally has a higher success rate.
The cause of capsular contracture is still being studied. According to an abstract in the Aesthetic Surgery Journal, (published by the American Society for Aesthetic Plastic Surgeons), states: “A growing body of evidence implicates subclinical (biofilm) infection around breast implants as an important cause of capsular contracture”.