Allergan Natrelle 410 Breast Implants get FDA Approval

Allergan Natrelle 410 Breast Implants get FDA Approval.

Seven years and 941 women later, Allergan has received FDA approval for its newest cohesive silicone gel breast implant. The Natrelle 410 Breast Implants are teardrop shaped, highly cohesive (gummy bear) implants that are approved for the cosmetic enhancement of breast volume in women 22 years or older, and for breast reconstruction at any age. Since the gel in these new breast implants is firmer, it retains its teardrop shape, but still gives when touched.

New Breast Implants Approved with a Condition

The approval comes with a condition. A breast implant follow-up study must be completed including 3500 women followed for 5 years and 2000 women for 10 years. Follow-up studies have been an FDA recent requirement for the approval of implantable devices, including previously approved breast implants.

What is a PMA Study, and Why They are Important?

I have been an investigator for the post-market approval (PMA) studies for all three US Breast Implant Manufacturers: Allergan, Mentor and most recently, Sientra. PMA studies are very important. They assure us that the new breast implants are as good as the pre-market research proved. The PMA studies also provide objective data that can be used to compare one type of breast implant to another. Larger numbers of participants also allow for the identification of the very rare occurrences.

Join a PMA study – It’s Less Than Free

PMA studies for breast implants carry no additional risk, and often include a small financial incentive to encourage continued participation. The amount is not enough to cover a Breast Augmentation, so it shouldn’t encourage anyone to get breast implants who wasn’t already considering the idea. However, the small financial carrots may help with the biggest problem encountered in long-term studies — people dropping out and becoming “lost to follow-up.”

Who is Eligible to Join?

PMA studies are designed to learn what happens after implantation. Participants are enrolled prior to surgery, and need to meet certain minimal requirements. The studies are closed once enough participants are recruited, and these participants will continue to be followed for the duration of the study (5 to 10 years). For Breast Implant Follow-up Studies, a yearly survey is completed in the comfort of your own home, and periodic follow-up examinations are performed in the office. Typically these are at 1, 5 and 10 years, though there is some variation.

Current PMA Studies with Open Enrollment

Currently, Sientra is enrolling new Breast Augmentation patients for the Sientra PAS (Post-Approval Study). It is named OASIS (Online Annual Sientra Implant Study). The PMA Studies for Saline and round Cohesive Silicone Gel Implants for Allergan and Mentor are closed; however, with the release of the 410′s a new PMA should be opening up. The investigators have not yet been selected. Stay tuned to the San Francisco Plastic Surgery Blog for more details!

One of the first, if not the first, in the area to complete FDA mandated training on the use of Allergen’s Natrelle 410 Breast Implants.

Posted in Breast Augmentation, Breast Reconstruction, Home | 1 Comment »

Excellent Medicine

Every now and then I am reminded what is great about being a doctor. I came across a posting on the Internet entitled: This letter from my late mother’s doctor has changed my life. It’s short and sweet and reminds me how big an impact one person can have on another.

The redacted version is included here, and a copy of the letter is included at the end of this post. It says a lot in a few words:

• Dear Mr. (blacked out),

  I am the Emergency Medicine physician who treated your wife Mrs. (blacked out) last Sunday in the Emergency Department at the New York Presbyterian Hospital. I learned only yesterday about her passing away and wanted to write to you to express my sadness. In my twenty years as a doctor in the Emergency Room, I have never written to a patient or a family member, as our encounters are typically hurried and do not always allow for more personal interaction. However, in your case, I felt a special connection to your wife (blacked out), who was so engaging and cheerful in spite of her illness and trouble breathing. I was also touched by the fact that you seemed to be a very loving couple. You were highly supportive of her, asking the right questions with calm, care and concern. From my experience as a physician, I find that the love and support of a spouse or a family member is the most soothing gift, bringing peace and serenity to those critically ill.

  I am sorry for your loss and I hope you can find comfort in the memory of your wife’s great spirit and of your loving bond. My heartfelt condolences go out to you and your family.

  (blacked out), MD
  

These short paragraphs say it all. Taking care of patients, even in the waining hours of health and life, is a great responsibility and privilege. To be a doctor, is a choice I made early in life that I have never regretted. I can hear the cynics out there saying, “You’re a Plastic Surgeon, not a real doctor.” Heck, I’ve heard some of my colleges make the same comment, but that’s not how I feel about it. I do specialize in Cosmetic Plastic Surgery, but “Do no harm” means knowing a lot more than how to do liposuction. I do also practice Reconstructive Plastic Surgery, and I don’t always get to give good news.

My thanks goes out to the gentleman who publicly shared this handwritten note from his mother’s ER doctor, as well as the doctor for so simply and legibly, expressing the impact that patients can have on their doctors, even if it’s just one visit. Last, but not least, thank you to my pateints for your trust and kindness.

Here is a copy of the original letter:

Excellent Medicine – A thoughtful letter from an ER doctor to a grieving family.

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Who is Qualified to do Plastic Surgery?

Dr. Mele is Board Certified by the American Board of Plastic Surgery

Any licensed physician can call himself or herself a Cosmetic Surgeon, so the importance of finding a properly trained and certified provider is paramount. The goal of this post is help patients looking for a qualified Plastic Surgeon know what to ask and how to check on their prospective doctor. I encourage everyone considering cosmetic plastic surgery to spend as much time researching their doctor as their procedure.

For Plastic Surgery Think PS

If you are considering cosmetic surgery there are three main goals that are mandatory, and the first two letters of Plastic Surgery can help. The three goals are:

• Proper Surgery
• Proper Surgeon
• Proper Setting

You want the most appropriate procedure performed by a qualified and experienced surgeon in a setting that provides for your safety.

Underground Plastic Surgery

Underground Plastic Surgery has grown along with the Board Certified variety. As Cosmetic Plastic Surgery has gained acceptance and popularity so has the quest for a bargain. There are no exact numbers, because those practicing cosmetic surgery illegally do not track or report their procedures to a national society like the American Society of Plastic Surgeons (ASPS) or the American Society for Aesthetic Plastic Surgery(ASAPS), but more about them later.

The way we usually hear about illegal plastic surgery is when something goes horribly wrong. On January 3, 2013, a second person was arrested and charged in the death of a 37-year-old woman who died from pulmonary complications after receiving silicone-like injections to enlarge her buttocks. The patient was introduced to the unlicensed practitioner after paying $200 to an Internet referral source. The fact that the procedure was performed at home, rather than a medical facility, should have been a big red flag.

This unfortunate patient had the wrong procedure, performed by the wrong person in the wrong setting. While fat grafting has gained some traction as a viable way to provide buttock enlargement in selected cases, there are currently no FDA approved off-the-shelf injections available in the US for buttock enlargement. Anyone offering these types of injections, no matter how low the cost, is not doing you a favor, and is not practicing medicine within the current standard of care.

Licensed Plastic Surgery

As mentioned above, any licensed physician can call himself or herself a cosmetic surgeon. At one meeting. I met a doctor, not from the San Francisco Bay Area, who performs Breast Augmentation one day a week, and works as an Emergency Room doctor the rest of the week. The state of California finds this perfectly reasonable, because he is a licensed physician.

Plastic Surgery was born from a union of General and Head & Neck Surgeons, who had an interest in plastic and reconstructive surgery. There is a lot of overlap between Plastic Surgeons and other specialists like Otolaryngologists, Ophthalmologists and even Gynecologists. Each of these specialists receives specific surgical training in their discipline, but Emergency Medicine?

Trained Plastic Surgery

I knew early on that I wanted to be a Plastic Surgeon. As a result, I chose the most direct path available: Surgical Internship, General Surgery Residency and Plastic Surgery Fellowship. All along the way I had my eye on the prize, to become a Board Certified Plastic Surgeon. I did not start learning plastic surgery after completing some other discipline. My desire to be a plastic surgeon shaped my training from its inception. I was fortunate enough to be in a General Surgery training program that had Plastic Surgeons, but no plastic surgery residents. This gave me the opportunity to get a head-start on my Plastic Surgery Training well before my Plastic Surgery Fellowship.

After finishing my General Surgery Residency, I completed a three-year Plastic Surgery Fellowship. There I concentrated only on plastic surgery. I was fortunate to train in a program that not only provided a firm foundation in Reconstructive Plastic Surgery, but also was strong in Cosmetic Plastic Surgery. This depth and breadth of this training cannot be provided by a weekend course, or a few proctored cases. It’s the best way to learn plastic surgery, and it is why I chose to complete a Plastic Surgery fellowship as my path to becoming a Plastic Surgeon.

Board Certified Plastic Surgery

The San Francisco Bay Area is currently home to two Plastic Surgery Training programs: UCSF and Stanford, and for a long time was home to the oldest plastic surgery training program west of the Mississippi at Saint Francis Memorial Hospital. Additionally, the Bay Area is a nice place to live, so finding a well trained Plastic Surgeon in our area is pretty easy.

Board Certification is a process that occurs throughout the course of a Plastic Surgeons practice. Lifetime certificates where given out before I started my training, but currently certification requires continuous maintenance. The details for Plastic Surgery Board certification are available here: Certification by the American Board of Plastic Surgery.

The goal of Board Certification is to provide recognition for the most qualified practitioners in their discipline. It means they have the best training and have been vigorously evaluated by other Board Certified doctors to make sure their expertise is up to the standard of care.

The Three PS’s

PS #1 – Proper Surgery - Finding the proper procedure on the Internet can be difficult. While there are many sources of good information, there are a lot of claims that are too good to be true. While it is good to have an idea of what procedure will work, it is best to reserve final judgement until after an in-person consultation. A big part of my job is listening to what is bothering you, and finding the best way to fix it.

PS #2 – Proper Surgeon - Finding a Board Certified Plastic Surgeon is a good start in being certain you have the proper surgeon. For selected procedures, there is overlap with other specialties. Board Certified Ophthalmologist are well trained in Blepharoplasty and Board Certified Otolaryngologists are well trained in Rhinoplasty. What you will need is a well trained professional with experience. This helps assure that good skills are coupled with good judgement.

PS #3 – Proper Setting - Real surgery requires the correct setting. While Botox and Injectable Fillers, and minor surgical procedures can be safely done in an office setting, Breast Augmentation, for example, should be performed in an operating room. An operating room in an accredited facility is preferable. Placing a Breast Implant requires an FDA approved device and sterile technique; otherwise, you won’t be keeping it long.

Membership Counts

To be an ASPS Member Surgeon, a physician must meet these rigid requirements:

• Board certified in plastic surgery by the ABPS
• Graduate from an accredited medical school
• Complete a combination of at least five years of general surgery and plastic surgery residency training
• Pass comprehensive oral and written exams
• Operate only in accredited medical facilities
• Adhere to a strict code of ethics
• Fulfill continuing medical education requirements, including standards and innovations in patient safety

An easy way to be certain you have the PS’s covered is to seek an ASPS member. If you are considering cosmetic plastic surgery, a subset of the society, the ASAPS, are ASPS members dedicated to the cosmetic side of plastic surgery.

You Owe it to Yourself

It takes dedication, persistence and effort to maintain Board Certification, and so does being a Plastic Surgeon. You owe it to yourself to do the research and check your plastic surgeon before having any procedure. The Internet makes it easy. The following links, will make it even easier. Just click on what you want to do:

Check if your doctor is Board Certified by the American Board of Plastic Surgery.
Check if your doctor is Board Certified by another American Board of Medical Specialties board. You will need to register to use this site, but it is safe, free and fast.
Check if your doctor has an unrestricted California Medical License. Read the disclaimer and click “Continue to Search” at the bottom. If you are not in California, Google your local medical board for a link.

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It’s Not All Boobs – Plastic Surgery Contributions

Since the invention of Reality(less) TV, plastic surgery has received its share of exposure over the last decade. The best known prime time incarnation, ABC’s Extreme Makeover, debuted in 2002. Unlike most its spawn, the show did obtain approval from the American Society of Plastic Surgery, but the emphasis was on the extreme end of the makeover. Plastic Surgery Reality TV peaked in 2004 with shows like: E!’s Dr. 90210, Fox’s The Swan, MTV’s I Want a Famous Face and Bravo’s Miami Slice. But reality TV’s infatuation with the fringes of plastic surgery has not died. As if brides were not stressed-out enough, in 2010 E! offered up Bridalplasty. Just this week, Toddlers and Tiara’s spin-off, Here Comes Honey Boo Boo, was followed by Plastic Wives.

Yep, they are in there.

More shock than substance, the pilot featured a woman who keeps her labia in a jar, and a former Extra host who seems to be considering it. While intellectually we all know that Reality TV is unreal, these types of shows feature real people, expressing real emotions in their own words, although edited for effect. The fantasy of it is seductive, but while for those featured it’s the truth, it is not the whole truth. A link to the Plastic Wives Preview is supplied; however, parental guidance is suggested.

There’s More to the Plastic Surgery Story

Plastic surgery is not all Boob Jobs. Don’t get me wrong, breast augmentation is an excellent procedure that improves the lives of hundreds of thousands of women every year in the US alone. One of the main reasons I enjoy practicing Plastic Surgery in the San Francisco Bay Area is the ability to provide a wide range of what plastic surgery has to offer. The range covers cosmetic surgery to congenital anomalies, and botox to breast reconstruction.

What do Plastic Surgeons do?

The yin and yang of Plastic Surgery are innate in the profession. Fifty years ago, American plastic surgeons Thomas Cronin and Frank Gerow invented the breast implant, and plastic surgeon, Joseph E. Murray performed the first cadaveric renal transplant. Granted, most people outside of medicine associate breast implants with plastic surgery; however, not too many know that the 1990 Nobel Prize in Medicine went to a plastic surgeon, Dr. Murray, and hematologist, E. Donnall Thomas, a fellow engineering major.

The 1990 Nobel Prize in Medicine was awarded to a Plastic Surgeon.

The two met at the Peter Bent Brigham Hospital in Boston, and remained friends and colleagues over the years because of their common interests in transplantation.

1990 Nobel Prize in Medicine

Dr. Murray refined many of the transplantation techniques and performed the first successful human kidney transplant on identical twins Richard and Ronald Herrick on December 23, 1954. The 1990 Nobel Prize was awarded for “discoveries that have enabled the development of organ and cell transplantation into a method for the treatment of human disease.” Transplant surgery has blossomed into a profession currently limited by donors rather than demand. New research into human tissue growth may soon remove this road block. While stem cell research and tissue engineering remain controversial, controversy seems to be an important governor of plastic surgery that improves, rather than hinders its outcomes.

Two is Better Than None

Dr. Murray and Dr. Thomas demonstrated how much we can accomplish when we work together. Both men passed away last fall, and they will be missed. A month after their passing, transplant surgery reached a new milestone. Iraq War veteran, Brendan Marrocco, became the first recipient of a dual arm transplant. Plastic and Orthopaedic Surgeon, Dr. Wei-Ping Andrew Lee, is carrying the transplantation torch over new ground, and Mr. Marrocco, who thrice had no pulse after loosing both arms and legs, is making unbelievable progress, back at home after his extensive surgery. It will be two more years before we will know if injured nerves in his shoulders will be able to reestablish a nerve supply, sensation and motion to the donor arms.

Opposites Attract

While Reality TV tends to put the spotlight on many of the most superficial aspects of our existence, there is much more beneath the surface.

Kiss nightclub fire in Santa Maria, Brazil.

Last week, Brazil suffered one of the worst accidents in its history. More than 200 young people died in a night club fire in Santa Maria, a university city located in southern Brazil. Dr. Carlos Uebel, president of the International Society of Aesthetic Plastic Surgery (ISAPS), lives about 150 miles away from the tragedy. He sent a personal account of the aftermath to me and the other ISAPS members:

1,500 boys and girls were in the private club to commemorate their graduation when suddenly a pyrotechnic show started the fire that burned all the walls and the ceiling material. Very toxic smoke spread over the people who could not exit quickly enough through the front door. Many of them were trampled and crushed on the floor.  Only 10% suffered serious burns with about 16 patients being treated in ICU burn centers in Santa Maria and Porto Alegre; however, many more out patients are coming for treatment.

Our “gaucho” families are suffering the second largest burn catastrophe in our country after the circus fire tragedy that occurred in Rio in 1961, and the third one to occur in worldwide night clubs. From this horrific tragedy, we have learned again that pyrotechnics inside a night club cannot be allowed; that building materials should be atoxic; that emergency exits are mandatory; and that occupancy laws must be obeyed.  
 
Our plastic surgeon colleagues from South Brazil thank those who have sent so many messages of support and condolence from around the world in this moment of intense sorrow.

The Reality of Plastic Surgery

This too is the reality of Plastic Surgery. It’s not all boobs. There will always be a large gap between the extremes of what we need and what we want, or even where the line is drawn in the grey in-between. Plastic Surgery is a large tent, with more than its fair share of sideshows. Even we Plastic Surgeons bicker amongst ourselves about what a “real” plastic surgeon is, but the discussion remains healthy. The knowledge and creativity that drive the profession fuel the extremes, but also foster an environment that allows for explosive growth. There is a big difference between reality and reality TV, for plastic surgery there is no exception. Whether we are replacing arms or just tightening them up, we are still plastic surgeons. For better of for worse, it a profession that offers something for everyone. Whether it is a moment of need, or want, Dr. Gaspare Tagliacozzi summed it all up back in 1597:

We restore, repair and make whole, those parts which nature has given, but misfortune has taken away, not so much that they might delight the eyes of the beholder but that they may buoy up the spirit and help the mind of the afflicted.

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