March 15th, 2014 Miguel A. Delgado Jr, MD
San Francisco, California-The American Society of Plastic Surgeons (ASPS) has reported their statistics for cosmetic and reconstructive surgery for 2013. Each year the report comes out around the end of February after the numbers have been tabulated from the Board Certified Members. It is interesting to see which procedures are the most popular and how they compare to previous years.
This is a 35-year-old resident of Sonoma County, California. She is the mother of two children. She presented to the Novato office in Marin County for an evaluation for breast enhancement. She is 5 feet 2 inches tall and weighs 115 pounds. She underwent bilateral breast enlargement using 300 cc, Mentor High Profile, silicone gel breast implants. The procedure was performed at the Marin Cosmetic Surgery Center in Marin County, California. The approach was a peri-areolar incision with sub-muscular placement for the breast implants. She went from a size A cup to a C cup.
ASPS reported that breast augmentation is once again the number one cosmetic plastic surgery procedure; it even increased over 2012. It is interesting to note that there has been a 37% increase for breast augmentation surgery since the year 2000, and the number one procedure since 2006 when it surpassed liposuction. It is not known why there was an increase for 2013, but it is believed that it may be due to new technology and approval by the FDA of form stable breast implants. Form stable implants are teardrop shaped silicone implants, also known as the “gummy bear” implant.
Taking a look at surgery trends over the last seven years (after breast augmentation), the number two procedure has been nose reshaping every year, except 2007 when it was liposuction. The third and fourth positions are fairly equal between liposuction and eyelid surgery. Fifth position had been tummy tuck surgery for six years and then for the last two years facelift surgery surpassed tummy tuck surgery taking the number five spot.
Patients have an increasing desire to look and feel their best, many come to their plastic surgeons complaining how they appear on Skype and Face Time on their phone. It is believed that competition in the work force is also a factor that has lead to an increase in all facial procedures.
In addition to cosmetic surgical procedures, the minimally invasive procedures have seen quite an increase for 2013. Botox remains in the number one position with an increase of 3% over 2012, with an amazing overall increase of 700% since 2000. The soft tissue fillers have seen an increase of 13% over 2012.
ASPS predicts that cosmetic surgical procedures will continue to see steady growth in the coming years, and especially the newer non-invasive body sculpting, (such as CoolSculpting), will see a dramatic increase.
Dr. Delgado is an expert in his field of cosmetic plastic surgery and has been since 1988, serving the greater San Francisco Bay Area, including San Jose and Sacramento.
July 1st, 2013 Miguel A. Delgado Jr, MD
San Francisco, CA-When the FDA called a moratorium on silicone breast implants in 1992, the road back to approval for these implants was very slow. The scare that the implants might be causing autoimmune diseases and various other complications made the implants unavailable to all except patients undergoing breast reconstruction surgery or breast augmentation revision surgery. That left women who wanted breast augmentation, saline breast implants as their only choice.
Mentor’s MemoryShape Implant
After many clinical trials, silicone breast implants were deemed safe and returned to market in 2006 for women 22 years of age and older. The approval comes with the understanding that the FDA recommends (not requires) that women have an MRI after three years of implantation and then every two years after that. The MRI is to watch for what is referred to as “a silent leak”. Within just a few years, the popularity of silicone breast implants surpassed saline implants by 80%.
Conducting trials for breast implants is very challenging for manufacturers, surgeons, patients and the surgeon’s staff. Once the excitement of the surgery has worn off, it is difficult to keep patients that are not having any issues to come in for their yearly visits, even with incentives offered by the manufacturer. In many cases, the patient may have moved out of the area, or there may have been staff turnover in the surgeon’s office and compliance starts falling through the cracks, making consistent follow up for 5 to 10 years daunting.
In anticipation of future FDA approval for silicone breast implants, manufacturers continued to develop new types of implants and started to conduct clinical trials. The “gummy bear” which is a colloquial term to describe the firmer anatomical cohesive gel implant, had trials beginning in 2001.
The highly cohesive implant made by Mentor is called “MemoryShape” and has been available for the past 10 years in 70 countries but not in the United States, until now. The “MemoryShape” implant has a tapered “teardrop” shape. It is thinner at the top and gently slopes to a fuller projection at the bottom. The shell has a subtle imprint; “Siltex Texture” designed to keep the implant in place.
The appeal of the anatomical shaped cohesive breast implant for most women is for a more natural look, youthful firmness and due to the high cohesiveness, they are less likely to ripple, rupture or leak throughout the breast tissue. For the downside, many women do not like the firmness or the risk of rotation of a teardrop shaped implant leaving them looking deformed. Also, it is very difficult to insert the implant through an incision around the areola, the recommended approach is the inframammary fold which requires a longer incision. The breast implant cost goes up by approximately $1000. The anatomical shaped implant does not work well with breast revision surgeries or for the woman who desires larger and/or softer implants and for the woman having a breast reduction with a lift and implant, will most likely be happier with the standard gel implants.
Allergan got FDA approval for their “gummy bear” implant, Natrelle 410 in February 2013, and Sientra got approval for their anatomical cohesive gel implant in March 2012. Mentor is the only company that manufactures their implants in the United States, but all implants available in the United States are manufactured with the same strict guidelines.
The anatomical cohesive gel breast implants vary in; their firmness, their shape and dimensions. They all have a textured shell to help the implant from moving out of place or rotating. The different manufacturers made their implants with different degrees of cohesiveness and they vary on how much gel they put into the shell. The more cohesive the gel is and the more they fill the shell, the better it will hold its shape, and is more resistant to shell folds, but will not feel as soft.
Since FDA approval of silicone gel breast implants in 2006, women have many more choices. There is fierce competition amongst breast implant manufacturers. Each manufacturer has its own philosophy for advantages and disadvantages for the different possible aspects of breast implants.
In deciding to have breast augmentation surgery, the patient needs to review all risks and possible complications with her surgeon and understand that implants are not lifetime devices. It is important to be aware of the fact that revision surgery will most likely be necessary at least once in a patient’s lifetime, and maybe more.
Surgeons have their own preferences and experiences with different implants. It is more important to find a Board Certified Plastic Surgeon that you trust, to help you determine what type of implant is best for you. Be sure to request to see many pictures, before and after breast implants.
April 15th, 2013 Miguel A. Delgado Jr, MD
36 year old mother of 1 child, at 5’3″ tall and 120 pounds, had a bilateral breast augmentation using Mentor normal-saline breast implants with a base size of 300 ccs inflated up to 325 ccs. bilaterally.
San Francisco, California-The cosmetic plastic surgery procedure breast augmentation or augmentation mammoplasty, remains the number one procedure and has been since 2006, according to the American Society of Plastic Surgeons (ASPS).
In 2006 when the FDA allowed silicone implants to return to market, 81% of women still chose saline implants. Today that has almost reversed, for 2012 72% of women chose silicone implants over saline according to the American Society of Aesthetic Plastic Surgeons (ASAPS). Most women prefer the more natural feel of silicone over saline. At the time of the initial consultation, Dr. Delgado reviews all the pros and cons of each breast implant, helping the patient decide which is best for her.
The cost for breast enhancement like any other surgery is affected by geographical area and the experience of the surgeon. In determining the surgical fee, besides the surgeon’s fee, is the fee for the implants, facility where the surgery is to be performed, garments, supplies, Keller Funnel if applicable and the anesthesiologist’s fee.
For Dr. Delgado, the fee for breast enlargement surgery with saline implants is $3000, with silicone implants it is $3500. The cost of saline implants is $1300, and the cost for silicone is $2000, plus $135 for the Keller funnel. The garment is $50, supplies $100. The surgery generally takes 2.5 hours at a cost of $1750 for Marin Cosmetic Surgery Center, and $750 for the anesthesiologist. The total then is $6950.00 or $8285.00 respectively.
Be sure to choose your plastic surgeon carefully, make sure he/she is Board Certified in Plastic Surgery as one or more revisions are likely through a woman’s lifetime. Revision surgery is more complicated than the initial surgery. Dr. Delgado has done hundreds of primary and revisional breast surgeries. About a third of his breast surgeries are revisional and in many cases he was not the initial surgeon.
July 6th, 2012 Miguel A. Delgado Jr, MD
Saline breast implant deflation
When contemplating breast augmentation surgery, many Marin County women ask how long breast implants will last. There is no way to know how, as it is different for everyone. There isn’t an expiration date on them. If you are not having a problem, they do not need to be replaced. You should be prepared to have breast revision surgery at least once in your life.
Basically all breast implants have the same design. They are made up of a silicone envelope and filled with either saline or silicone gel. Breast implants can develop a tear or hole. Ruptures or deflations can happen if there is a severe blow to the chest or aging of the implant. If implants are old, it is possible that they can rupture during a mammogram. Saline implants have a valve. If the valve is defective, or breaks, it will deflate.
Recent advancements for breast implants have made them safer and longer lasting than ever. Breast implant manufacturers stand behind their products and give them a lifetime replacement warranty. They also extend a ten year warranty for reimbursement of some of the surgical costs, if breast revision surgery becomes necessary.
January 20th, 2012 Miguel A. Delgado Jr, MD
There have been a lot of reports in the news lately about a French manufacturer of defective breast implants used for breast augmentation surgery. It was discovered that Poly Implant Prothese (PIP) a now defunct company had been using industrial grade silicone instead of the more expensive medical grade for their silicone implants. According to Wikipedia, industrial grade is only 10% of the cost of medical grade.
In 1996, PIP was selling their saline implants in the United States including the San Francisco Bay Area, but saline and silicone implants were distributed to many countries worldwide. All silicone implants were banned in the United States from 1992-2006 due to health concerns but reintroduced after extensive testing proved them to be safe. Only two breast implant companies are approved by the FDA, Mentor and Allergan.
PIP became the third largest breast implant company in the world before being shut down in 2010 when the discovery was made. A Dutch company rebranded the implants with the name Rofil M-implants, and is also at risk as the contents are the same. In 2000 the FDA sent an inspector to the PIP manufacturing company and found many substandard practices thereby banning all PIP implants for the United States.
The American Society for Aesthetic Plastic Surgery (ASAPS) recommends women have the implants removed due to the high rupture rate and also due to the fact that the adverse effects of the impurities used in industrial grade silicone are unknown. The International Society of Aesthetic Plastic Surgery (ISAPS) supports this recommendation. Different countries have different recommendations. Several countries recommending removal besides the United States are; France, Germany, Venezuela and the Czech Republic. Some countries are setting up registries and hotlines but not recommending removal at this time.
Dr. Delgado recommends that women who have had breast augmentation surgery outside of the United States to get in touch with their surgeon to verify what type of implants they have. Dr. Delgado also stresses the importance of all women to know the brand, size of their implants and if they are saline or silicone.
For a limited time, Dr. Delgado is offering a reduction in surgical fees to San Francisco Bay Area women who wish to have their PIP implants removed. For more information please contact the office.
November 7th, 2011 Miguel A. Delgado Jr, MD
The Food and Drug Administration advisory panel has recommended setting up a nationwide registry to track safety problems for women with silicone breast implants for ten years.
It is not believed that the implants might not be safe; in fact in 2006 the FDA broke a 14 year moratorium on silicone implants by approving two new implants, one made by Allergan and one made by Mentor. But critics of the approval wanted more evidence for long term use.
The FDA required the two manufacturers to have follow-up studies of 40,000 patients each, ending in 2016. But the manufacturers have had a hard time complying. Allergan so far has about 60% follow-up and Mentor about one in four patients of their original 40,000. The manufacturers need to get the doctors to comply who in turn need to get the patients to comply. It is difficult to get women to continure to come in for yearly follow-up visits and filling out long questionnaires when they aren’t haven’t any issues. The idea of the breast registry is still in its beginning stages and the idea of having incentives for doctors and their patients is being considered.
The panel also discussed the current recommendation that women have an MRI (to look for a silent leak) three years after implantation and then every two years thereafter. They pointed out that most insurance companies don’t cover an MRI if there isn’t a problem, and most women are reluctant to pay out of pocket. Therefore the panel recommended not requiring future post-approval studies to mandate women who are not having issues undergo an MRI.
February 6th, 2011 Miguel A. Delgado Jr, MD
Several articles have been recently published on the possibility of a link between a rare cancer called anaplastic large-cell lymphoma (ALCL)and breast implants. Articles have appeared in Cosmetic Surgery Times, Modern Medicine and Medscape, to name a few.
ALCL is a non-Hodgkin’s lymphoma, a rare cancer of the immune system that can occur anywhere in the body. 1 out of 500,000 women per year are diagnosed with ALCL in the United States. Even more rare is ALCL of the breast, 3 out of 100 million annually for women without breast implants.The FDA says that the risk is so small that they continue to support a “reasonable assurance” that FDA approved implants are safe.
According to the American Society for Aesthetic Plastic Surgery, Inc. (ASAPS), the condition is incredibly rare with only 34 cases worldwide in the past 25 years among an estimated 10 million implanted devices. It is believed that the vast majority of plastic surgeons will never see a single case in a lifetime of practice. To put the odds into perspective, according to the National Weather Service, the chances of being struck by lightning in any given year are 1 in 700,000.
In most cases the cancer was discovered when women were seeking treatment for implant related symptoms such as; pain, swelling, lumps or asymmetry, after healing from breast augmentation. For women with implants the cancer is usually inside the scar tissue of the capsule and is not considered breast cancer.
Hopefully this information will put San Francisco and Bay Area women’s mind at ease, however anyone with questions or concerns should have a discussion with their plastic surgeon.