February 9th, 2011 Dr. Mele
Screening mammography, an important part of breast cancer diagnosis.
Remember when the revised US Preventative Service Task Force (USPSTF) recommendations for breast cancer screening were released in November 2009? Like the recent FDA White Paper and Advisory Statement on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants, the USPSTF caused quite a stir. A the heart of the controversy was the USPSTF’s advice against the long time recommendation for routine screening mammograms for women beginning at age 40. The USPSTF recommended delaying routine screening until age 50.
Immediately, cash strapped county health organizations and large HMO organizations alike, debated cutting dollars to fund screening mammograms for women under 50. Meanwhile, a large number of US health care organizations, including the American Society of Plastic Surgeons (ASPS), the American Cancer Society (ACS), the American College of Radiology (ACR), and the American College of Obstetricians and Gynecologists (ACOG), recommended that physicians and patients continue to follow earlier guidelines. They recommended to continue screening mammography for patients aged 40 to 49, despite the government committee’s recommendation to start at age 50. The recommendation to continue screening at 40 was based on all previous studies showing a benefit to finding early breast cancer.
40 is Still the Right Age for a Screening Mammogram
Two years later, the advice to continue screening mammograms at age 40 seems to have been right on the mark. I don’t think this comes as a surprise to anyone who cares for women with breast cancer; however, a study published in the American Journal of Radiology, which analyzed the same data as the USPSTF concurs with the earlier guidelines. According to the analysis, women who receive annual mammograms starting at age 40 can significantly reduce the risk of dying from breast cancer by 71 percent. This is in stark contrast to women who follow the USPSTF recommendations, who had only a 23.2-percent reduction in mortality.
What Have We Learned?
The lesson here is not that government is bad, but that science is good. The practice of medicine is based on the odds of something helping more than it hurts. While studies may at times seem to offer conflicting advice, carefully analyzing the details can often resolve the issue. In this case, the data used in the USPSTF study was used to prove the point. So ladies, if you are 40, it is time to get your mammogram.
How Does Science Work?
The best scientific tool we have is the prospective, randomized, controlled, blinded study. But what does that mean?
- Prospective: the study is planned before the data is collected. In this way, data known to be conflicting can be accounted for, and will be less likely to distort the results. The opposite of a prospective study is a retrospective study, where data from the past, often not collected in the best way possible, is used to evaluate a treatment plan.
- Randomized: patients are randomly selected to enter the treatment groups. This is very important. This allows for equity in the treated and untreated groups. For example, patients with a family history of breast cancer tend to have a higher incidence of breast cancer. If all patients with a family history of breast cancer elected to have early mammograms, as one would expect them to, the incidence of breast cancer would be higher in the group that received early mammograms. Without additional information, it would be assumed that mammograms caused more breast cancer. This would not be true, but the data would support it, because of the way the study was designed.
If patients are randomly assigned to the early and late mammogram groups, patients with a family history would be randomly (evenly) distributed between the two groups. The net effect would be the same expected incidence of breast cancer in both groups. In a randomized study, if the group with early mammograms had more breast cancer, it would indicate that the mammograms may be causing the problem. This is not what randomized studies show. We know that mammograms require radiation, and radiation can cause cancer; however, for all studies done, mammograms find and cure more breast cancer than they cause for women over 40.
- Controlled: A control group is a group that is compared to treatment under study. If you have a new treatment, and you want to prove that is provides a benefit, you need to compare a group of patients receiving the new treatment to a group receiving the current treatment. The current treatment group serves as the control group. Comparing a new treatment to no treatment, may show that the new treatment is better than nothing, but it will not prove that is better than the currently accepted treatment without the head-to-head comparison.
- Blinded: Blinded studies are designed so that the patients do not know which treatment they are receiving. Sometimes the doctors and health professional conducting the study are kept in the dark too. This is to prevent investigator bias, and to help randomize the placebo effect.
The Ideal Study for Screening Mammograms at Age 40
The mammogram on left is of normal glandular breast tissue. The white circle in the mammogram on the right is breast cancer.
So, the ideal test to prove the benefit of mammograms to screen for breast cancer between ages 40 to 49 would need the following under each of the categories described above:
- Prospective: Before the study is started, protocol is established. This would include who would be studied (women age 40) and what conditions would be excluded (men, women who already have breast cancer, women with other severe health problems). The number of women needed to prove statistical significance. Reasons for dropping out, and how to handle the data collected for those dropping out. It might be good to estimate the number expected to drop out, so that the remaining groups could still show statistical significance.
- Randomized: How women are selected to be in each group. Toss of a coin, even or odd days of birth, anything unrelated to the mammograms or breast cancer, so that the two groups will be as equal as possible in all the variables that are not being controlled.
- Controlled: A definition of the control group is established. In this case, the control group needs to be matched for age, family history of breast cancer, smoking, weight and all other variables known to contribute to breast cancer. This way the study group receiving the mammograms, and the control group not receiving the mammograms, will be as equal as humanly possible.
- Blinded: While not likely in this type of study, the best control group would do everything the study group does except get mammograms. A clever sham for the control group, would be to use mammogram machine, have it make a noise like a mammogram was done, but not use any radiation. No mammogram would be taken, but it would not be possible for the patient, and in some cases, even the mammogram technologist to know if a real mammogram was done. This way, if there was some other factor in the mammogram room that caused breast cancer, like the paint on the wall, that increased the risk of breast cancer, the exposure would be the same. Blinding can also prevent investigator bias. For example, if an investigator was truly convinced that there was a benefit to treatment, they would be less likely to allow someone with a family history of breast cancer to go into the control group and not receive treatment.
So the above study would have to run ten years to provide mammograms for the women from age 40 to 49, and to provide no mammograms for the control group. Then data will need to continue to be collected throughout every participants life to see if there was a benefit. Were tumors found sooner? Smaller? Once the diagnosis was made was the treatment for breast cancer easier? More effective? How many had recurrences? Were recurrences local, or were the recurrences to other organs like the lungs, liver, brain or bone? Did patients live longer in the screened group? The main question is, did fewer women in the screened group die of breast cancer?
Unfortunately, Compromise is Necessary
It might take 50 or 60 years to get the final results, and it would be very expensive to run this test. As a result, this type of testing, even though ideal, is never done. Often, new treatment protocols are unblinded early for ethical reasons. A separate group of investigators may be asked to review the unblinded results. This prevents bad treatments from doing more harm, and prevents good treatments from being withheld from the control group.
It is very important to keep the above principles in mind when reviewing data. Unblinded results can be dangerous if the investigator has a bias. Recent developments in the vaccine and autism controversy come to mind. It is important to remember that risk is always relative. Risks that occur often, but cause small problems may be acceptable. A cream that causes temporary burning, but clears a rash is acceptable. Even terrible consequences may be acceptable if they are very rare. An antibiotic that clears a particularly difficult and dangerous infection 99% of the time, but can lead to liver failure and death in 1 in a million treated with it, would be acceptable if they had a better chance of dying without the antibiotic.
Medicine and the Evening News
The evening news is not the best place to get medical information. While many reports are fair, most are sensationalized. Increased drama equals increased viewership, and that leads to more advertising dollars. The motivation to inform is in all reporters and producers, but if the story is not interesting, it will never air.
So in 2011, doctors are still recommending screening mammograms, beginning at age 40. For women with a family history of breast cancer developing at a young age, earlier screening may be recommended. The study by the American College of Radiology (ACR), is much more thoughtful, and certainly more objective, than the US Preventative Service Task Force (USPSTF) recommendations. But you won’t see the same prime time news coverage tonight for the ACR paper that we did in 2009 when the USPSTF made their announcement. The results are not as … interesting.
Posted in Home, Patient Safety | No Comments »
January 27th, 2011 Dr. Mele
Saline filled breast implants.
Yesterday, the FDA released a White Paper and Advisory Statement on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants. It is important that all patients and plastic surgeons understand the current state of knowledge surrounding this condition.
What Are My Chances of Getting ALCL if I Get Breast Implants?
This condition is incredibly rare. In fact, the known ALCL cases are too few to say conclusively that breast implants cause the disease. Efforts over the past 25 years by all the worlds major plastic surgery societies to raise awareness among members and to identify patients with ALCL have identified 34 unique cases worldwide among an estimated 10 million+ implanted devices. That’s about 1 in 300,000. To put this in perspective: the chance that you will get hit by lightning at some time during your lifetime is 1 in 6250. The chances are the same of you knowing 50 people who have been hit by lightning or one person with breast implant associated ALCL. On the other hand, the chance a developing a “real” breast cancer is 1 in 9.
So it’s Rare … but What if it Happens to Me?
As opposed to the systemic, nodal pattern of ALCL, in published reports, ALCL seen in the presence of breast implants has demonstrated an indolent course. In other words, it doesn’t spread. The women who developed ALCL, were cured with treatment. While ALCL seen in the presence of breast implants does fulfill the current WHO classification for ALCL, a form of Non-Hodgkins Lymphoma, the type of ALCL associated with breast implants potentially represents a distinct clinical entity. This condition is clearly NOT breast cancer.
Because of the extreme rarity of this condition, at this point no standard treatment has been determined. ALCL has been treated with everything from simple explantation (removal of the breast implant) and capsulectomy (removal of the scar around the breast implant) to aggressive systemic therapy. With either treatment, the condition was resolved.
Where Does the FDA Stand?
The FDA has not changed the status or availability of breast implants and has reaffirmed that the devices are safe and effective. In order to better understand this rare condition, the FDA has entered into an agreement with the American Society of Plastic Surgeons (ASPS) to create a registry for ALCL cases in the presence of breast implants. Until this registry is up and running, any clinical case will be reported directly to FDA. The FDA documents provide instructions for how to report any clinical cases to FDA. The American Society for Aesthetic Plastic Surgery fully supports the FDA and ASPS in this endeavor.
It’s Rare … But What Should I Look For?
Despite what you may have heard on the nightly news, the vast majority of breast implant patients will never have this problem. Moreover, most plastic surgeons will never see a single case in a lifetime of practice. The occurrence of ALCL with implants is so rare that routine screening of asymptomatic patients is not indicated; however, we all need to know what signs to look for.
The Presentation of ALCL with Breast Implants
This unusual tumor presents in two main ways:
- A collection of fluid (a seroma) that develops well after breast implant placement
- A mass involving the scar around a breast implant (the capsule)
Non specific findings: pain, lumps, swelling, or asymmetry, have also been associated with the above findings, and some cases have been associated with capsular contracture (firmness of the breast). If you think there is a problem, contact your Board Certified Plastic Surgeon today for follow-up.
ALCL Does Not Act Like Breast Cancer and There is More Good News
Knowledge is power. Raising awareness should be empowering and not frightening. Recent news reports on ALCL and breast implants seem a bit overblown; however, they do serve as a reminder that all women, with and without breast implants, need to be concerned about breast health. While ALCL is unlikely, the incidence of breast cancer is one in nine, and the vast majority of women who develop breast cancer do not have a family history of the disease.
The good news it that breast health is being discussed openly. I encourage you to do monthly breast exams, and to obtain routine mammography. The sooner a breast cancer is found, the easier it is to treat, and the better the quality of the life saved. Routine screening may seem a bother, but the life you save, will be yours to enjoy.
The ASAPS, the ASPS and Board Certified Plastic Surgeons around the world are all working together on this and other issues to keep cosmetic plastic surgery safe and predictable for everyone. For more information on ALCL and breast implants follow these links:
Posted in Breast Augmentation, Home, Patient Safety | 4 Comments »
September 5th, 2010 Dr. Mele
Every now and then, a State Bill comes along that just makes sense. AB 583 is such a bill. It has no hidden agenda, it is easy for health care practitioners to comply with and it provides meaningful objective information for patients.
AB 583 (Hayashi) requires health care practitioners to disclose their name, license type (RN, MD, DO, etc), highest level of academic degree received and for physicians, their board certification. This information must be placed on the health care practitioner’s website, and is also required to be given to the patient in writing at the initial patient encounter or must be prominently displayed in their office.
As simple as this sounds, it has taken over three years of work by many members of the California Medical Association and the California Society of Plastic Surgeons to get this bill on Governor Arnold Schwarzenegger‘s desk.
AB 583 is not yet a law. There is some debate, mostly from practitioners who are not Board Certified, to withhold any type of disclosure requirement. As a Board Certified Plastic Surgeon, I fully support this disclosure. As a Walnut Creek Plastic Surgeon, I have many well educated patients. I have had to care for patients who have seen less qualified practitioners, and who have received questionable treatment and results. Often they are surprised and embarrassed to find out the “Plastic Surgeon” they had entrusted with their health, was not a Board Certified Plastic Surgeon, and in some cases, was not even a doctor.
Critics will say that even the best Board Certified Plastic Surgeons can have poor results. While this is true, when the correct approach is instituted from the start, the chances of a poor result are significantly decreased, and the chances of recovery from a poor result are significantly enhanced.
The more you know as a patient, the safer you can be. In California, anyone with a Physicians and Surgeons License can perform plastic surgery. Non-MD oral surgeons are allowed to do facial plastic surgery. AB 583 helps patients by requiring your health care provider to inform you about the type and duration of training they have received. This will not protect you from the truly unscrupulous, but it will help you to know the type of training any ethical health care practitioner has received.
I encourage you to support passage of AB 583. Letters can be sent to the Governor here:
The Honorable Arnold Schwarzenegger
Governor of California
State Capitol Building
Sacramento, CA 95814
or you may fax your letter to 916 558-3160.
Your opinion is important. Please act before September 17th (the earlier the better) to let your viewpoint be heard.
Posted in Patient Safety | No Comments »
August 20th, 2010 Dr. Mele
Dr. Joseph Mele, guest author for ABoardCertifiedPlasticSurgeonResource.com
I was recently asked to contribute to A Board Certified Plastic Surgeon Resource, an online resource helping patients find Board Certified Plastic Surgeons. My article stresses the importance of Board Certification, and explains how to recognize a true Medical Board.
Most Medical Boards are self regulating. The long standing, traditional medical boards are also under the regulation of the American Board of Medical Specialties (ABMS). Under the ABMS the only Board specifically dedicated to Plastic Surgery is the American Board of Plastic Surgery. Other sound-alike boards, for example The American Board of Facial Plastic Surgery and the American Board of Cosmetic Surgery, have not been accepted as ABMS Boards, and thus fall outside the regulation of the ABMS.
Information about the American Board of Plastic Surgery can be found right here on the San Francisco Plastic Surgery Blog: Board Certified by the American Board of Plastic Surgery.
For the full version of the article, click the picture below.
Dr. Mele's article on Board Certification
Posted in About Dr. Mele, Patient Safety | No Comments »
August 16th, 2010 Dr. Mele
The International Society for Aesthetic Plastic Surgery (ISAPS) started its 40th anniversary meeting this weekend in San Francisco. While the majority of the meeting will be spent discussing the finer points of plastic surgery technique, Saturday was spent discussing patient safety on a global scale.
The ISAPS is leading the way in global guidelines for plastic surgery patient safety. Topics included:
- Uniform global plastic surgeon certification requirements
- Uniform global facility accreditation requirements
- Medical Procedures Abroad ™ i.e. Medical tourism
- Guidlines for patient safety
- Medical device guidelines and usage
Sunday was spent discussing Blepharoplasty (eyelid surgery) and Rhytidectomy (face lift surgery). Today was dedicated to Rhinoplasty (nasal surgery) and Mammoplasty (breast surgery: breast augmentation, breast implants, breast enhancement, breast reduction, beast reconstruction, congenital breast deformities and breast lift surgery).
Tomorrow Maria Siemionow, MD, the team leader of the first U.S. face transplantation surgery, will be making a special presentation. Tuesday will focus on aesthetic reconstructive surgery, as well as Abdominoplasty (tummy tuck) and Body Contouring (liposuction and body lifts).
The final day of the conference, Wednesday, will be spent on Cosmetic Medicine and finally Patient Safety and Complications. It’s been great so far. If you would like more information on any of these procedures, please click on any of the Categories to the left, or visit my main website: DrMele.com.
Posted in Patient Safety, Plastic Surgery Societies | 1 Comment »
August 11th, 2010 Dr. Mele
Body Art
Body art traditionally refers to tattoos and piercings, but some would say cosmetic plastic surgery is a form of body art. It is not scalpelling, but a scalpel is used. As body art becomes more main stream, questions regarding breast augmentation before and after nipple piercing come up more often than you might think.
 Preexisting Body and Nipple Piercing - Before Breast Augmentation |
 After Breast Augmentation - Body and Nipple Piercings Survived. |
Pre-Existing Nipple Piercing
If you have pierced nipples, and are considering breast implants, breast augmentation can be safely performed in the presence of pierced nipples. A few precautions need to be taken to maximize the safety and predictability of you surgery:
- The piercings need to be clean and without irritation. Irritated piercings are a set up for infection, and this could lead to an infection around the breast implants.
- The jewelry should be removed from the piercing immediately before surgery. Electrocautery is used routinely during surgery to prevent bleeding. An electric shock to your piercings would cause a burn.
- The jewelry should be replaced immediately after surgery. At the end of the breast augmentation I normally replace the jewelry to prevent the piercing from closing.
- If the piercing should become irritated or infected after surgery, it should be addressed immediately. Sometimes this means removing the jewelry from the piercing.
Nipple Piercing After Breast Augmentation
If you already have breast implants, and are considering getting your nipples pierced, I don’t recommend it. If you are still determined to get a nipple piercing, you need to be especially vigilant. Choose a reputable establishment, which uses sterile technique. Infections can occur with any piercing, and every infection has the potential to spread.
Nipple piercings can be especially problematic as the breast gland itself can become infected. This can put the both the breast tissue and the breast implants at risk, especially if your breast implants are in front of the pectoralis muscle. If there is any redness, swelling, discharge or increasing pain at the piercing site, call you plastic surgeon, and seek immediate treatment. The jewelry may need to be removed, but it is better to lose a piercing than to lose a breast implant.
Posted in Breast Augmentation, Patient Safety | No Comments »
July 8th, 2010 Dr. Mele
Dr. Mele is an Active Member of the California Medical Association (CMA)
The California Medical Association (CMA) was formed as the State Medical Society of California on March 12, 1856. The initial membership totaled 75 physicians who held their first meeting over 154 years ago at Pioneer Hall on J Street in what is now Old Town Sacramento. In 1923, the association was renamed the California Medical Association. At its 150th anniversary the membership totaled 35,000.
The CMA continues to support the people of California. It has studied the effects of lack of access to care for the poor since the 1930s, and tried to get legislation passed in the state and nation that would establish compulsory health insurance. They continue to advocate for health insurance for all, via voluntary participation, through legislation, policy and the courts.
I was privileged to see how the society works first-hand as the California Society of Plastic Surgeons Young Physician Representative to the CMA, dealing with issues such as access to care and the distribution of vaccines. The CMA continues to work closely with County Medical Societies to assist with local problems, with State Legislators for statewide medical issues, and with the American Medical Association for national health issues.
Posted in Home, Patient Safety, Plastic Surgery Societies | No Comments »
July 6th, 2010 Dr. Mele
Dr. Mele is a Lifetime Member of the American Medical Association (AMA)
The American Medical Association (AMA) was founded in 1847 at the Academy of Natural Sciences by Nathan Davis. With it, the first minimum standards for medical education were established. The original goals of the AMA where to:
- advance the science of medicine
- improve the standards for medical education
- develop a program of medical ethics
- improve the health of the public
The often quoted Journal of the American Medical Association (JAMA) was established in 1883. This was not the first journal created by the AMA. Indeed, the Archives of Ophthalmology, Archives of Otology and the Journal of Cutaneous Diseases (now Archives of Dermatology), all preceded the JAMA.
Through the 1900′s the AMA had a tremendous amount of influence over medicine in North America. In public health, it helped to craft national legislation for the control of tuberculosis (TB) and smallpox. In medical education, it inspected and accredited medical schools and curriculums, set standards for internship and specialty training, and encouraged the recognition of specialty boards. It formed many other more influential bodies, including:
There are over 814,000 doctors licensed in the United States of America. State medical societies used to require that their members were also AMA members. After several states dropped this requirement in 1971, the AMA lost over 11,000 members. Today approximately 15-20% of practicing physicians are members.
As the number of physician member decreases, so does funding that comes from dues. Increasingly, the association’s income comes from advertising, CPT and ICD-9 code licensing, and information technology. This has caused controversial decision making in the recent past. The Sunbeam scandal is one glaring example. Despite the controversies, the AMA remains a potent political force, with the ability to influence regulations locally and nationally.
Posted in Home, Patient Safety, Plastic Surgery Societies | 2 Comments »
July 4th, 2010 Dr. Mele
Dr. Mele is a Fellow of the American College of Surgeons (FACS)
Just the FACS Ma’am
Ever wonder why some doctors have FACS after their name? It means they are members of the American College of Surgeons (ACS). FACS stands for: Fellow of the American College of Surgeons. To be a member, a surgeon’s education, training, professional qualifications, surgical competence and ethical conduct have passed a rigorous evaluation, and have been found to be consistent with the high standards established and demanded by the College.
The American College of Surgeons
Established in Chicago, in 1913, the society has 73,000 American Surgeons and more than 4,000 surgeons from other countries. The college’s main activities include the:
- Annual Clinical Congress and other sponsored continuing medical activities
- Commission on Cancer to improve the care of cancer patients
- Committee on Trauma to improve the management and prevention of injuries
- Division of Advocacy and Health Policy monitors legislative and regulatory issues affecting the field of surgery
- Sponsoring of the Residency Review Committee for Surgery and the Surgical Specialties including Plastic Surgery
- Office of Public Information provides general information about surgeons and surgical care
- Surgical Education and Self-Assessment Program (SESAP) a resource for surgeons lifelong learning, and to prepare for Board Certification
- Publications:
So if you are a patient, the letters FACS after a surgeons name mean the American College of Surgeons has independently evaluated and accepted their qualifications.
Posted in Home, Patient Safety, Plastic Surgery Societies | 2 Comments »
June 22nd, 2010 Dr. Mele
Dr. Mele is a Active Member of the International Confederation for Plastic Reconstructiive and Aesthetic Surgery (IPRAS)
The International Confederation for Plastic, Reconstructive and Aesthetic Surgery (ICPRAS) is the largest plastic surgery society on Earth. Since 1955, meetings have been held around the world to foster the advancement of Plastic Surgery. Previous sites include:
- Stockholm (1955)
- London (1959)
- Washington (1963)
- Rome (1967)
- Melbourne (1971)
- Paris (1975)
- Rio de Janiero (1979)
- Montreal (1983)
- New Delhi (1987)
- Madrid (1992)
- Yokohama (1995)
- San Francisco (1999)
- Sydney (2003)
- Berlin (2007)
- Vancouver (2011)
I was fortunate to have attended the last Quadrennial congress held in San Francisco (1999). While it was 11 years ago, almost 90 National Societies were represented, more than twice the founding 39 National Societies.
The IPRAS has four Chapters, each with its own International Society.
- Reconstructive Microsurgery
- Hand Surgery
- Aesthetic Plastic Surgery
- Craniofacial Surgery
These cover the main areas of subspecialization in Plastic Surgery. Aesthetic Plastic Surgery is represented by the International Society for Aesthetic Plastic Surgery (ISAPS) which will be having its meeting here, in San Francisco, this August.
Practicing Plastic Surgery in the San Francisco Bay Area has advantages. San Francisco is a nice place to visit, so we attract many state, national and international plastic surgery meetings. This certainly makes it convenient to attend the best Plastic Surgery Conferences in the World.
As plastic surgery advances and expands, international societies like the IPRAS and the ISAPS will continue to provide a wide range of experience and perspective.
Posted in About Dr. Mele, Home, Patient Safety, Plastic Surgery Societies | 1 Comment »
