Posted by Padraig O Connell on Mon, Feb 27, 2012 @ 06:40 AM
Many of my
Cosmetic Breast Surgery patients continue to ask me if I believe that Fat Grafting for Breast Augmentation is a safe procedure. Although I have written a previous Blog on this topic, I have recently re-reviewed the medical literature on this topic. Three important Journal Articles on this topic were published in the primary Plastic Surgery Journal,
Plastic and Reconstructive Surgery, in the last 10 months.
All three (3) articles compared the results of mammograms taken of breasts after fat transfer looking for clustered microcalcifications to the breast tissue. Microcalcifications of the breast are considered to be diagnostic of Breast Cancer unless proven to be non-Cancerous by breast biopsy.
One of the three studies (48 patients) determined that 17% of patients developed microcalcifications following fat grafting to the breast that could not be distinguished from breast cancer and required biopsy. This study was a prospective study that followed patients over a 10 years. A second study reviewed the charts and mammograms of 20 patients over 8 years (retrospective) and concluded that although they though the procedure was safe...more patients should be studied. Finally, a third study compared the mammograms of patients who underwent breast reduction surgery (in the US) to those who underwent cosmetic fat grafting in Japan. They concluded that the mammograms of the American breast reduction patients had more microcalcifications that the Japanese patients who underwent cosmetic fat grafting and as a result, that fat grafting was a safe procedure. The conclusion of this study has been subject to considerable debate.
In summary, I am still not convinced that fat grafting to the breast for
cosmetic breast augmentation is a safe procedure over time. Between 15% and 20% of patients who undergo this treatment will develop an abnormal mammogram that will require multiple breast biopsies to be certain that the microcalcifications are not breast cancer. I am hopeful that a new breast imaging study will be developed that will replace the mammogram as the primary breast cancer screening procedure for women. When that new breast imaging study is available, then fat grafting of the breast can be re-evaluated regarding its long term safety.
Christopher D Prevel, MD, FACS
Posted by Padraig O Connell on Mon, Jan 16, 2012 @ 02:09 PM
As the Human Medical Tragedy of the PIP Silicone Breast Implants unfolds, additional information has been released by the American Society of Aesthetic Plastic Surgeons (ASAPS), the primary Aesthetic (Cosmetic) Plastic Surgery Society in the US. According to a recent White Paper from the ASAPS released on 01/12/12 to its members, like myself, all patients who have had the PIP Silicone Breast Implants placed at any time should have them removed even if the implants are not ruptured. In addition to PIP, a Dutch Company, Rolfi Medical, used a similar inferior industrial grade silicone gel in their breast implants. The problems associated with this silicone gel includes a much higher incidence of implant rupture (over 3.5 times higher when PIP ( FDA approved) Saline implants were compared to Mentor (FDA approved) implants) and the unknown risks of the impurities contained in the industrial grade silicone. These risks could include an increased risk of cancer and/or auto-immune disorders.
These implants include all PIP Silicone Gel Breast Implants since 2001 as well as those sold by Rolfi Medical in the Netherlands and Rolfi Medro in Germany. The ASAPS also states that it is believed that the Silicone Breast Implants made by both companies before 2001 are also defective. In addition, No PIP or Rolfi Silicone Breast Implants were ever FDA approved although PIP Saline Breast Implants were FDA approved for sale in the US in the first half of the last decade. PIP and/or Rolfi Silicone Breast Implants were available for sale in the following countries: United Kingdom, France, Germany, Czech Republic, Argentina, Brazil, and Venezuela.
Although the FDA is often critiqued for delaying the introduction of new medical devices from around the globe, in this case, FDA oversight prevented American women from being exposed to this health hazard. All Allergan and Mentor Breast Implants that have been available for sale in the US have always been subject to FDA evaluation/approval and are deemed to be safe.
Posted by Padraig O Connell on Mon, Jan 09, 2012 @ 04:23 PM
Over the last several weeks, a tragic story of greed and arrogance has unfolded across the EU and South America. A French Breast Implant Company, Poly Implant Prosthese (PIP) has been charged with selling an unsafe silicone breast implant containing an additive, Baysilone, used in the industrial fuel and rubber industries. This additive along with Silopren and Rhodorsil were found in the silicone gel of PIP Breast Implants recently analyzed by a French Toxicologist hired by the French Network RTL. These additives combined with the industrial grade silicone gel are attributed to cause the high rate of rupture of these implants compared to those produced by the US FDA approved silicone gel breast implants sold by Allergan,Inc. and Mentor Corporation. In fact, PIP Saline Breast Implants have not been FDA approved for sale in the USA since 2000, and PIP Silicone Gel Breast Implants have never received FDA approval.
The former President of PIP, Jean-Claude Mas, is in hiding from French Authorities who are seeking to arrest him over charges of manslaughter and fraud. In the recent past he was quoted as saying that his customers are "psychologically frail' women who are only trying "to make money" from him.
According to his Attorney, Yves Haddad, PIP produced a more expensive silicone breast implant using FDA approved medical grade silicone sold by Nusil. However, the company was facing bankruptcy and as a result, created a second silicone breast implant that contained a internally fabricated industrial grade silicone gel that was at least 80% cheaper to produce. This silicone was never intended for human use and would have never been approved by any of the EU Health Ministries.
Thus, Mr. Mas could be considered to have begun his own clinical trial studying industrial grade silicone gel Breast Implants using European and South American women as his test subjects...More to follow...
Posted by Dr. Chris Prevel on Tue, Oct 25, 2011 @ 08:06 PM
A recent article in the Wall Street Journal by Katherine Hobson indicates that women in their forties and fifties who receive a yearly screening Mammogram over a 10 year period have a 7% to 9% chance of a false positive mammogram study. That means that 7 to 9 women out of 100 received an unnecessary breast biopsy due to a falsely positive mammogram study. Women who chose to receive bi-annual mammograms have a 1/3 lower risk of a false positive biopsy and do not have a statistically higher risk of a diagnosis of late stage breast cancer.
The important message of this study is that women without a positive family history of breast cancer or other significant risk factors for breast cancer may be better off receiving a bi-annual instead of an annual mammogram after the age of 40. However, this decision must be made only after a long and detailed consultation with your gynecologist.
Posted by Padraig O Connell on Wed, Oct 19, 2011 @ 03:55 PM
Over the last several years, Plastic Surgeons have utilized Fat Transfer/Fat Grafting to aid in the Reconstruction of the Breast following Mastectomy/Breast Tumor surgery. When used for this purpose, the procedure is a safe and effective method for Reconstruction of the Breast. However, over the last 2 years, Wall Street Investors have funded several companies that promote the use of Fat Transfer for Cosmetic Breast Augmentation instead of Breast Implants to increase Breast Size. This is despite several significant disadvantages:
1. Fat Grafting will only reliable increase the size of the breast by 1/2 Cup.
2. Fat Grafting to the Breast can result in calcifications to the Breast that can be confused with early Breast Cancer. (Reference: ASAPS Patient Safety: Fat Grafting for Breast Augmentation – What Women should know)
3. Fat Grafting can result in Breast Cysts and Lumps due to Fat Cell necrosis/death with resultant scarring that requires additional surgery for removal.
4. "The American Society of Aesthetic Plastic Surgeons and the American Society of Plastic Surgeons, in the interest of Patient Safety, do not recommend fat grafting for breast enhancement at this time. Because there is little clinical evidence available to document safety and efficacy, we urge patients to consider the procedure as one undergoing continued evaluation." (Reference: ASAPS Patient Safety: Fat Grafting for Breast Augmentation – What Women should know)
Be certain that Fat Grafting is the procedure that is best to achieve your cosmetic breast goals. Fat Grafting is a widely accepted technique for Reconstruction of the Breast following Breast Cancer surgery, but is still a highly debated procedure for elective cosmetic breast augmentation surgery.
Posted by Dr. Chris Prevel on Sun, Apr 03, 2011 @ 05:47 PM
After Breast Implant surgery, I always discuss with my patients the topic of future dental or other surgical procedures and how they can affect their implants. This is an issue that does not have one opinion or recommended treatment. As a result, I will share the recommendations that I offer my patients. Another Plastic Surgeon, Richard Dowden, MD, FACS, has offered his opinion regarding this topic on his web site blog, http://dr-dowden.com/faqs/impldent.html
Breast Implants are a semi-permanent (since they do not last the life of the patient and can be removed without creating a life threating condition) body implant. Like all similar implants, they can become contaminated through a systemic (whole body) infection or through a transient (momentary) bacteremia (bacteria in the blood stream). Infection in certain body implants (heart valves, heart pacemakers) can cause a life threatening condition and as a result, it is routine for specific antibiotics to be given to patients with those devices before dental work, Stomach-Colonic Endoscopy GI-GU surgery, Sinus surgery and Lung procedures. In addition, patients with a specific heart valve condition are also required to take antibiotics to reduce the risk of a blood infection.
Infections in Breast Implants usually cause a condition called "Capsular Contraction," (CC) or hardening of the breast tissue around the implant. This condition results in a breast that is misshaped and painful. Thus, the use of Prophylactic Antibiotics prior to the surgical procedures listed above is to reduce the chance that this condition will occur. If CC does occur, a reoperation in necessary and the chance that CC can return can be greater than 50% in some patients. However, since CC is not life-threatening and the risk of this condition occurring is low (see Dr. Dowden's Blog) many Dentists and Surgeons do not consider the risks of side effects from the antibiotics worth the low risk of CC occurring without taking the antibiotics.
I agree with Dr. Dowden that although the risk for CC to occur is low, I recommend my Breast Augmentation patients to take Prophylactic Antibiotics 1 (one) hour prior to dental cleaning/surgery/implants or any of the above invasive surgical procedures. No other doses are necessary unless they are recommended by the Dentist/Oral Surgeon/Surgeon for prevention of infections related to the dental or other surgical procedure you are being treated. The specific antibiotic and the dosage should be discussed with your Plastic Surgeon and will be based upon your specific condition, medication allergies and any other medications that you may be taking.
In summary, it is important to have a discussion with your Plastic Surgeon before and after your Breast Implant surgery to review the benefits and risks of Prophylactic Antibiotics related to Dental/Invasive Surgical procedures to reduce your risk of Capsular Contracture.
Posted by Dr. Chris Prevel on Fri, Mar 18, 2011 @ 04:39 AM
Large breasts or "Macromastia" is a common condition that afflicts many women around the globe. A combination of genetic composition and an elevated Body Mass Index (BMI) results in breasts that cause symptoms that include: neck pain, back pain, shoulder pain, headaches, bra strap grooving, and chronic rashes. Despite the use of padded bras, anti-inflammatory medications, powders-creams to the skin, back-shoulder therapy and anti-inflammatory medications these symptoms persist. In many cases, where the bra cup size is a DD cup and larger, Breast Reduction Surgery is the treatment of choice (please refer to www.drprevel.com under Breast Reduction Surgery for additional information).
For those women who have health insurance coverage, a challenge can be obtaining prior approval from their health insurance carrier (HIC) for the surgery. In addition, each carrier has criteria that are specific for that company. Getting approval at the first submission is important, since the "appeals process" is long, painful and often unsuccessful.
From my experience over the last 20 years, although the criteria for approval change annually, I have found the following process to increase the likelihood of approval:
1. Visit your Internist/Family Physician/Gynecologist and begin a treatment program that consists of supportive measures (padded shoulder strap bra, anti-inflammatory medications, physical therapy, and powders to the skin) for at least 3 months. Have copies of office notes from your doctor that these measures have not been successful in relieving your symptoms (neck pain, back pain, shoulder pain, headaches, and skin rashes) and ask your doctor to write a letter confirming that these treatments have not been successful. The letter must state that she/he recommends Breast Reduction Surgery for treatment of these symptoms. Both the letter and copies of the office notes are needed by your Plastic Surgeon.
2. Obtain X-Rays of the neck (C-spine films). If these films indicate a herniated disk or other spine disorder, you must obtain a consultation from a Neurosurgeon or Orthopaedic Spine surgeon before visiting your Plastic Surgeon to determine if this disorder requires any treatment before your Breast Reduction surgery. A copy of the X-Ray report and any office notes from this consultation are needed by your Plastic Surgeon.
3. Provide documentation that your symptoms have lasted for at least 12 continuous months.
4. If 35 or older, have a bilateral breast mammogram and bring a copy of the report to your Plastic Surgery consultation.
5. Go to your health insurance carrier's (HIC) web site and search for their criteria (Clinical Policy Bulletin) for application for prior approval for Breast Reduction Surgery. Before visiting your Plastic Surgeon for your consultation for Breast Reduction Surgery, print up a copy of the approval criteria and bring it to the consultation to review with your Plastic Surgeon. If she/he believes that you are a good candidate for surgery, they will obtain photographs of the breasts and submit these along with a letter from their office, a copy of all of the documentation from your Physician including any X-ray reports.
6. Ask your Plastic Surgeon to submit all of this documentation to your HIC for prior approval for your Breast Reduction Surgery. You and your Plastic Surgeon will usually be informed simultaneously regarding the status of your request for prior approval.
Proper documentation of the requested information from your HIC as listed on their web site is essential for approval for your Breast Reduction Surgery from your Health Insurance carrier.
Good Luck!
Dr Christopher Prevel
Posted by Dr. Chris Prevel on Tue, Feb 08, 2011 @ 05:21 PM
A new analysis of information used by the US Government to cut back breast cancer screening reports that the Government ignored evidence that more frequent mammograms save more lives. A recent article in the American Journal of Roentgenology used some of the same data used by the U.S. Preventive Services Task Force (USPSTF) to issue their controversial breast screening guidelines in 2009.
Those guidelines recommended against routine mammograms for women in their 40s and said women in their 50s should get mammograms every other year instead of every year.
In the new analysis, the team from the University of Michigan Medical Center (M GO BLUE) found that annual mammograms starting at age 40 save 65,000 more women from breast cancer than mammograms done every other year in women 50 and older.
The new research team calculated that a woman who gets a yearly mammogram starting at age 40 cuts her risk of dying from breast cancer by 71 percent compared to a 23 percent reduction in risk if a woman followed the task force recommendations.
The researchers wrote that "the USPSTF chose to ignore the science available to them and overemphasized the potential harms of screening mammography, to the serious detriment of U.S. women who follow their flawed recommendations."
Many groups, including the American Cancer Society, have continued to recommend a yearly breast exam for women starting at age 40, stressing that the breast mammograms have been proven to save lives by spotting tumors early, when they are most easily treated.
Breast cancer is the second-leading cause of cancer death among U.S. women. Around the globe, 500,000 women die every year from breast cancer and it is diagnosed in close to 1.3 million women.
Just as a yearly Pap Smear is an important screening test for the early diagnosis and treatment of Cervical Cancer, a baseline mammogram at age 35 and yearly at 40 and beyond is an important screening test for the early diagnosis and treatment of breast cancer.
Posted by Dr. Chris Prevel on Mon, Jan 10, 2011 @ 10:29 AM
One of the most difficult decisions that my breast augmentation patients face is choosing the size of their breast implants. It is a time consuming process that is filled with uncertainty. The preparation for breast augmentation surgery should be an exciting time, not one filled with dread.Over the last several years, we have used a system in my office to help women size their breast implants in the comfort of their home. As a result, very few patients are now "surprised" at the size of their breasts after surgery. A few "supplies" are necessary to create your "sizer implants."Supplies: 1. One clear glass 2 Cup measuring cup with red lettering (Pyrex® brand) that has both ounces and cc/ml on the sides. 2. One box of Zip Lock® sandwich bags or the bottoms (ankle/foot) of a pair of old panty hose.3. Bird seed (preferred)/small grain rice. 4. Buy a new non-padded bra or "sports bra" in the size that you want to "fill" after your surgery. Cut any under wire out of the bra. Choose a department store with a large lingerie department such a Macy's or JC Penny. I recommend using Victoria Secret for your bra purchase AFTER surgery, NOT BEFORE, for your "sizer" bra. This is due to the inconsistency of their bras for sizing purposes. Measure the amount of the filler for your "sizer" implant using the metric (cc/ml) side of the measuring cup to create the size that you want to use. Pour the birdseed from the measuring cup into the Zip Lock® bag or the panty hose legs. You can use tape to "form" a better shape of the "sizer" after you have filled the bag. Create several different "pairs" of "sizer" implants using 25 cc increments, such as 225cc, 250cc, 275cc, etc. Remember that for most patients a volume of 200 ml to 250 ml is needed to increase the size of the breast by 1 (one) bra cup size. Thus, to increase from an "A" cup to a "B" cup will take an implant of at least 200ml.Then look in your closet or dresser drawers for your favorite dress, blouse, camisole or T-shirt. Place the sizers into your new bra that you want to fill after surgery followed by your choice of clothing and model in front a mirror. Also, ask your trusted friends, significant other, and/or family members how the different sizes look.With this new information, your office consultation for sizing your breast implants will be an enjoyable experience and the first step for your new look that you have dreamed about.