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.
April 30th, 2013 Miguel A. Delgado Jr, MD
San Francisco, California-Dr. Delgado was selected by Haute MD to join their prestigious directory of top physicians. Haute MD is an upscale internet publication with informative stories on the latest health and beauty trends. The online publication offers readers access to premiere cosmetic specialists around the country.
Due to his exceptional reputation and skills, Haute MD has featured Dr. Delgado as their newest member as a specialist in plastic surgery for the body, including such procedures as; breast augmentation, breast revision, tummy tuck, mommy makeover and gynecomastia or male breast reduction.
Besides having a directory for top physicians, Haute MD also gives the readers a detailed profile of the doctor’s with before and after pictures of actual patients, videos the doctors may have produced and patient testimonials.
The exclusive website delivers San Francisco Bay Area men and women intriguing articles like:
• “Auriculotherapy Beads for Celebrity Wellness”
• “Cupping Celebrity Health Fad: Groundbreaking or Totally Useless?”
• “Benefits of Dead Sea Salt”
• “Power Juice and How it Helps You”
“Haute MD connects the most trusted doctors and specialists with the country’s most discerning affluent audience. The network is an exclusive, invite only membership circle with only one representative per market for each of the nine medical specialties.”
July 25th, 2012 Miguel A. Delgado Jr, MD
Increasing Implant Size
One of the main reasons Sonoma County and Marin County women have a breast revision surgery is to increase the size of their implants. A common complaint among many women is that they wish they had gone larger when they had their initial breast augmentation surgery. It is very important to have clear communication with your surgeon when determining the size.
There are a variety of techniques that are used to assist in determining breast size. One of the most common breast size test is the rice test: another is the Mentor Volume Sizing System.
Women who wish to have very large breast implants need to understand that the size is limited by their body dimension and frame. As the size of the breast implant increase, the width increases and can “out-pace” the size of your chest. Your surgeon will take measurements and advise you of your options.
July 6th, 2012 Miguel A. Delgado Jr, MD
Silicone breast implant
There are different situations that require breast revision surgery for San Francisco patients. One is called the “double bubble”. The double bubble is the result of a secondary crease caused by the breast implant resting below the natural crease, also known as the inframammary fold.
If the surgeon is aware of this during breast augmentation surgery, there are steps that can be taken to correct it. However, if the double bubble occurs after surgery and after the implant has settled, it will require revision surgery by an experienced Board Certified Plastic Surgeon such as Dr. Delgado who serves patients in Marin and Sonoma counties.
February 21st, 2012 Miguel A. Delgado Jr, MD
PIP BREAST IMPLANT
In a Press Release dated January 17, 2012, Dr. Delgado explains the dangers of the French made Poly Implant Prosthese(PIP) breast implants. Starting in 2001 the manufacturer was using industrial grade silicone instead of medical grade for their gel breast implants. Use of industrial grade silicone makes them more prone to rupture and leakage.
The news media carried many stories starting in December 2011 warning women of the potential danger. Many countries recommended women to have the PIP implants removed, but some countries only recommend that women seek the advice of their doctor. Dr. Delgado points out that the American Society for Aesthetic Plastic Surgery (ASAPS) recommends that women with PIP implants have them removed.
For women in the United States, silicone implants were not available from 1992 to 2006 due to possible health issues but when they were proved safe, the FDA once again approved them. However PIP silicone implants were never approved for sale in the United States and therefore would not have been implanted in any American women unless they had breast augmentation surgery outside of the U.S. Dr. Delgado recommends that all women know; the size, manufacturer and if their implants are saline or silicone.
It is believed there are at least 40,000 women in the U.K. that have PIP silicone implants. Britain set up an expert committee to examine specific risks associated with the implants and to date they have concluded that if a woman is not having any symptoms that there is not enough evidence to recommend early removal. However the government is offering for women to have removal and replacement if they have PIP implants at no charge if the patient had the surgery by the National Health Service (NHS) ¸who routinely does reconstruction after mastectomy with implants. The government thinks that private clinics will follow suit. In the meantime, the NHS is warning women to watch for symptoms such as:
• lumpiness of the breast
• lumpiness or swelling in the area around the breast
• change in shape of the breast
• deflation of the breast
• tenderness of the breast
• swelling of the breast
• pain or sensitivity
Recently in a BBC news report dated February 15, 2012, a woman from Edinburgh, Scotland went in for a breast scan after hearing the warnings in the news. She was horrified to discover that one of her implants had indeed ruptured and silicone had gone into her lymph nodes. A further disturbing fact is that she had no symptoms, no pain and no change in the shape of her breast. She was totally unaware that she had a rupture.
Meanwhile, the Paris based International Master Course on Aging Skin (IMCAS) which represents plastic surgeons and dermatologists had their annual conference in Paris, January 27, 2012 and according to IMCAS the PIP affair seems to be having a short term impact. Beauty procedures including liposuction, breast augmentation, and Botox injections grew globally in 2011, up 10.1%, and set to grow 11.12% in 2012. It is believed that approximately 20 million women worldwide have breast implants, and PIP only represents 1.5% with about 400,000 women using the product.
If you think you may have PIP implants or Rofil M-Implants (rebranded PIP implants by a Dutch company) Dr. Delgado recommends that you get an evaluation by a Board Certified Plastic Surgeon.
November 18th, 2010 Miguel A. Delgado Jr, MD
Revisional breast surgery or breast augmentation redo, is one of the most common procedures performed after breast augmentation. Almost 100% of women undergoing breast augmentation will require a revisional breast surgery during some point in their life. This may take the form of replacement due to breast contraction or hardening, deflation or slow leakage; mound position of the breast implant or a change in shape of the breast after pregnancy.
The art of revisional surgery requires much breast surgery experience since this is a corrective procedure. Due to the amount of scarred tissue that is present and the issues that require revision breast surgery, choosing a surgeon initially with great experience and confidence is critical.
Breast revisional surgery may entail; excision of scarring and replacement of implants which may be with larger or smaller implants. Or it may be replacing the implants and doing a Mastoplasty or breast lift to reposition the skin and tissue or possibly to remove the implant with the leakage of silicone and replacement of the implant. Regardless of which issue exists, a customized surgical plan must be created to accomplish the goals that you may have. Dr. Delgado has over twenty years of experience working with breasts performing breast surgery. This takes the form of breast augmentation, breast lifts, breast reduction, and breast reconstruction. Dr. Delgado has many photographs to share regarding these procedures. You may view more by going to his website at www.dr-delgado.com