PIP Implants: a problem in America, not just France

February 3rd, 2012  

Last week Jean-Claude Mas, the founder of now-defunct breast implant manufacturer PIP, was arrested by French authorities.  His company, Poly Implant Prothese (PIP), was closed in March 2010 amid controversy.  He is accused of manslaughter and involuntary injuries caused by ruptured silicone PIP implants, which were made from industrial-grade silicone (designed for use in mattresses), rather than medical grade silicone.

PIP silicone gel implants have been used in over 300,000 breast augmentations worldwide since 1999, and there are currently investigations pending in France, England, Venezuela, and Brazil.  French authorities are recommending and paying for removal of PIP silicone gel implants in French women due to the very high rate of rupture and unknown risks of exposure to industrial-grade silicone.

How is this relevant to us in America?  I was listening to a report about PIP implants on National Public Radio last week, and the commentator assured the radio audience that no PIP implants were ever placed in the United States.  This is simply FALSE.  The reality is that although PIP silicone gel implants were never used, lots of PIP saline implants have been used in the U.S.–over 35,000 by some estimates.

PIP began selling saline implants in the US in 1996.  In 2000, the Food and Drug Administration (FDA) rejected the devices due to high deflation rates, manufacturing process violations, and a failure to demonstrate device safety.  Despite the FDA ban, PIP continued to sell their saline implants through its distributors, MediCor/Heritage Worldwide, until late 2002 or early 2003.  The FDA has received over 1,800 reports of problems with the PIP saline implants.  Most of the complaints concern an abnormally high product failure (deflation) rate.

While the PIP saline implants are not nearly as worrisome as the PIP silicone gel implants, this should serve as a cautionary tale for plastic surgeons, patients, and U.S. regulators.  How did PIP “slip through the cracks” for years after it was banned?

The only saline and silicone gel breast implants approved by the FDA for use in the US are manufactured by Allergan and Mentor. In the nearly 2500 breast augmentations that I have performed in the past 16 years, I have ALWAYS used implants made by Allergan or Mentor.  And yes, there are still unapproved manufacturers marketing breast implants in the United States.  Before you undergo breast augmentation, always know exactly what you are putting in your body.

 

For more information about procedures performed, please visit www.plasticsurgerydallas.com

Ronald M. Friedman, M.D.

Director, West Plano Plastic Surgery Center

Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas

www.plasticsurgerydallas.com

 

Dr. Friedman Named Best Cosmetic Surgeon in Denton County

January 30th, 2012  

Ronald M. Friedman, M.D., has been voted the Best Cosmetic Surgeon in Denton County for 2011. This distinction was based on a poll of 30,000 readers in Flower Mound, Highland Village, Lantana, and Castle Hills conducted by Allen Publishing Company.

Dr. Friedman is a board-certified plastic surgeon who specializes in breast enlargement, breast lift, liposuction, tummy tuck, mommy makeovers, and facial rejuvenation.  With offices in Flower Mound (across from Presbyterian Hospital of Flower Mound) and Plano (at Presbyterian Hospital of Plano), he has served the residents of Lewisville, Highland Village, Irving, and Las Colinas since 1996.

Dr. Friedman, who is widely recognized for his attention to detail and natural-appearing results, has also been honored by his peer physicians as a D Magazine Best Doctor in Dallas (2008, 2009, 2010, 2011) and as a Texas Monthly SuperDoctor (four consecutive years).

For more information about Dr. Friedman, including before-and-after photos, please visit www.plasticsurgerydallas.com.

Why Does My Tummy Stick Out, and What Can I Do About It?

January 23rd, 2012  

There are three possible reasons for the abdomen to protrude:

1.   Excessive abdominal wall fat

    This is best addressed by dieting, exercise, and weight loss and/ or abdominal liposuction.

    2.   Excessive laxity of the abdominal wall

      Pregnancy, significant weight loss, and aging loosen the abdominal wall.  Full tummy tuck entails permanent sutures used to tighten the weak, protruding abdominal wall in the midline from the rib cage to the pubic region.  If a hernia (hole in the abdominal wall) is present, it may also be repaired.

      3.   Excessive intra-abdominal fat

        This is best addressed by dieting, exercise, and weight loss.  Plastic surgery will not help.

        How can I tell which one is causing my protrusion?

        It is best to be evaluated by a board-certified plastic surgeon, although you can certainly get an idea of what is causing your protrusion by answering a few questions and looking carefully at your abdomen.

        1. Have you lost a significant amount of weight?  If so, you probably have excessive laxity of the abdominal wall and may benefit from tummy tuck.
        2. How many children (if any) do you have?  In general, women with more children have more laxity of the abdominal wall.   In the absence of children and weight loss, you probably do not have major abdominal wall laxity.
        3. Can you “pinch more than an inch?”  If you can pinch more than an inch of abdominal fat, you may have excessive abdominal wall fat.  If you are unable to get rid of this with diet and exercise, then liposuction may be helpful.
        4. Do you have a hard, round abdomen (“beer gut”)?  If so, you probably have excessive intra-abdominal fat.  Since the fat is inside the abdominal cavity, plastic surgery will not help.

        There are many surgical options for excessive abdominal protrusion.  These include liposuction, mini-tummy tuck, extended mini-tummy tuck, and full tummy tuck.  Remember that you should be within 5 to 10 pounds of your desired weight before considering cosmetic surgery of the abdomen.  If diet and exercise aren’t helping, liposuction or tummy tuck may be worthwhile considerations.

         

        Side view of abdominal wall layers(fat inside tummy, abdominal wall muscle and fat)

        Lipo:

        Liposuction of abdomen, hips and flanks. Breast augmentation.

        Before                                                                After

        Full tummy:

        Full tummy-tuck and breast augmentation

        Before                                                               After

        Full tummy-tuck and breast augmentation

        Before                                                               After

         

        For more information, including before / after photos, please click here.

        To schedule an appointment, please call us at 469-467-0100 or email us at drfriedman@plasticsurgerydallas.com

        Ronald M. Friedman, M.D.

        Certified, American Board of Plastic Surgery

        Director, West Plano Plastic Surgery Center

        Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas, Texas

        www.plasticsurgerydallas.com

        Before and After Breast Augmentation with Lift Photos in Plano, Frisco, and Allen, Texas

        August 25th, 2011  

        Breast augmentation with simultaneous breastlift is a technically challenging procedure.  This is due to the fact that we are simultaneously expanding the breast size with a saline or silicone gel implant while contracting the amount of skin via mastopexy (breast lift).  Despite these challenges, in a woman who desires larger and perkier breasts, this combination of procedures achieves what neither procedure can do alone.

        The best way to evaluate a surgeon is to view his surgical results.  As a specialist in breast and body contouring, I strive to achieve natural and proportionate breast enlargement and mastopexy results.

        As you view the photos below, look for

        1. Increased breast size proportionate to the patient.
        2. Improved nipple-areolar position.
        3. Improved fullness of the upper and inner breasts.
        4. Improvement or resolution of  “sagging.”

         

        1. Breast Augmentation with lift, Saline Implants (Patient also had Full-Tummy tuck):

        Implant size: 300 cc implants; Incision: Vertical Mastopexy

        Estimated size change: 38D to 38 Full D; Height and Weight: 5’4″, 175 lbs

        2. Breast Augmentation with lift, Saline Implants:

        Implant size: 420 cc implants; Incision: Vertical Mastopexy

        Estimated size change: 36C to 36D; Height and Weight: 5’6″, 136 lbs

        3. Breast Augmentation with lift, Saline Implants:

        Implant size: 330 cc  implants; Incision: Periareolar mastopexy

        Estimated size change: 34A to Full C; Height and Weight: 5’4″, 125 lbs

        4. Breast Augmentation with lift, Silicone gel Implants (Patient also had Full-Tummy tuck):

        Implant size: 421 cc implants; Incision: Vertical mastopexy

        Estimated size change: 34 small C to 34 Full C; Height and Weight: 5’3″, 106 lbs

        5. Breast Augmentation with Silicone gel implants

        Implant size: 360 cc implants; Incision: Vertical mastopexy

        Estimated size change: 34B to 34 Full C; Height and Weight: 5’4″, 135 lbs

        Our breast augmentation with lift patients come from all over Texas (Dallas, Fort Worth, Lubbock, Denton, Wichita Falls, Austin), Oklahoma, Arkansas, and Louisiana.

        For blogs that I have written on specific breast enlargement topics, please see:

        1. Determining breast implant size
        2. Saline vs. silicone gel
        3. Safety of silicone gel
        4. Low, moderate, and high profile implants
        5. Smooth vs. textured implants
        6. Implant placement above vs. below muscle
        7. Capsular contracture

         

        For articles that I have written on specific breast enlargement topics, please see:

        1. Cost of breast augmentation
        2. Breast augmentation with vs. without breast lift

         

        For more information about breast augmentation–including more photos, please visit www.plasticsurgerydallas.com

        Ronald M. Friedman, M.D.

        Director, West Plano Plastic Surgery Center

        Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas

        www.plasticsurgerydallas.com

         

         

         

         

        Before and After Breast Augmentation Photos in Plano, Frisco, and Allen, Texas

        July 7th, 2011  

        The average plastic surgeon performs about 30 to 35 breast augmentations annually.  I performed 70 breast enlargements—in the first 6 months of 2011.  The best way to evaluate a surgeon is to look at his surgical results.  As a specialist in breast and body contouring, I strive to achieve natural and proportionate breast enlargement results.

        Remember that the single greatest factor determining the appearance of your breasts after augmentation is the appearance of your breasts before augmentation.  As you view the photos below, notice that a woman’s breast shape changes very little with augmentation.  The primary changes are increased breast size and increased fullness of the upper breasts.

        1. Breast Augmentation with Saline Implants:

        Implant size: 330 cc implants; Incision: Inframammary fold

        Estimated size change: 34B to 34C;  Height and Weight: 5’7″, 119 lbs

        Before (Front view)                 After (Front view)        Before  (Side view)  After (Side view)

        2.   Breast Augmentation with Saline Implants:

        Implants: 420 cc implants ; Incision: Inframammary fold

        Estimated size change: 36B to 36D  Height and Weight: 5’9″, 140 lbs

        Before (Front view)                 After (Front view)          Before  (Side view)  After (Side view)

        3. Breast Augmentation with Saline Implants:

        Implant size: 330 cc implants; Incision: Inframammary fold

        Estimated size change: 34c to 34D;  Height and Weight: 5’4″, 122 lbs

        Before (Front view)                 After (Front view)        Before  (Side view)  After (Side view)

        4. Breast Augmentation with Saline Implants

        Implant size: 360 cc implants; Incision: Inframammary fold

        Estimated size change: 34 small B to Full C;  Height and Weight: 5’4″, 130 lbs

        Before (Front view)               After (Front view)                 Before  (Side view) After (Side view)

        5. Breast Augmentation with Saline Implants

        Implant size: 360 cc implants; Incision: Inframammary fold

        Estimated size change: 34B to 34 Full C;  Height and Weight: 5’0″, 95 lbs

        Before (Front view)                 After (Front view)        Before  (Side view)  After (Side view)

        6. Breast Augmentation with Silicone gel implants

        Implant size: 421 cc implants; Incision: Inframammary fold

        Estimated size change: 32B to 32C;  Height and Weight: 5’5″, 120 lbs

        Before (Front view)                 After (Front view)        Before  (Side view)  After (Side view)

         

        Our breast augmentation patients come from all over Texas (Dallas, Fort Worth, Lubbock, Denton, Wichita Falls, Austin), Oklahoma, Arkansas, and Louisiana.

        For blogs that I have written on specific breast enlargement topics, please see:

        1. Determining breast implant size
        2. Saline vs. silicone gel
        3. Safety of silicone gel
        4. Low, moderate, and high profile implants
        5. Smooth vs. textured implants
        6. Implant placement above vs. below muscle
        7. Capsular contracture

         

        For articles that I have written on specific breast enlargement topics, please see:

        1. Cost of breast augmentation
        2. Breast augmentation with vs. without breast lift

         

        For more information about breast augmentation–including more photos, please visit www.plasticsurgerydallas.com

        Ronald M. Friedman, M.D.

        Director, West Plano Plastic Surgery Center

        Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas

        www.plasticsurgerydallas.com

         

         

        Plastic surgery reality check: cosmetic surgery is just not that much fun (Dallas, Plano, Frisco, Richardson, McKinney, Carrollton, Irving, Southlake, and Lewisville)

        June 8th, 2011  

        Although television shows such as The Swan and Extreme Makeovers make cosmetic plastic surgery look exciting and glamorous, this so-called “reality” couldn’t be farther from the truth.

        Cosmetic surgery remains popular because it makes people look and feel better.  But make no mistake: it is real surgery with real risks and downsides.   In my 15 years operating on patients from Dallas, Plano, Frisco, Richardson, McKinney, Carrollton, Irving, Southlake, and Lewisville, I have learned the realities of cosmetic surgery firsthand.

        Virtually every surgical procedure is associated with the following negative factors:

        1.      Scars:  Like it or not, any time you cut the skin, your body generates a scar.  Part of my job is to make the scar look as inconspicuous as possible—but there’s still a scar.  This is a necessary trade-off for the desired improvement in contour.

        2.      Pain: Surgery hurts.  There is no such thing as a painless surgical procedure.  You will require pain medicine (from anywhere from a couple days to a couple weeks), and you may wonder what you were thinking the first couple days after surgery.  Fortunately, pain is temporary and generally well-controlled by medication.  But it is unavoidable.

        3.      Time off work:  You may be tough, but the combination of surgery, anesthesia, and pain medication will result in some time lost from work.  If you have a desk job, you will likely be back to work very soon.  If your job requires significant lifting, you may have to modify your work activities for several weeks.

        4.      Time off athletic activities:  For most breast and body contouring procedures, you will require 4 to 6 weeks off heavy lifting, pushing, and pulling.  (This includes strenuous workouts and lifting your children.)  It’s inconvenient but very necessary.

        5.      Risks: Infection, bleeding, need for further surgery, unsatisfactory cosmetic results (to name a few).  The good news: 90 to 95% of patients are happy with their surgical results.  The bad news: 5 to 10% are not.

        I feel privileged to be able to make a living doing something I really enjoy.  But cosmetic surgery is more fun for me than it is for you.  Make sure that your plastic surgeon takes the time to thoroughly educate you before you undergo any procedure.

        Our cosmetic surgery and plastic surgery patients come from Dallas, Fort Worth, Plano, Frisco, McKinney, Allen, Richardson, Garland, Sherman, Denison, Prosper, Celina, Wichita Falls, Parker, Highland Village, Denton, Arlington, Irving, Southlake, Carrollton, Lewisville, Colleyville, and Trophy Club.   For cosmetic surgery before and after photos, please visit www.plasticsurgerydallas.com .

        Ronald M. Friedman, M.D.

        Director, West Plano Plastic Surgery Center

        Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas

        www.plasticsurgerydallas.com

        Cirugia para reducir el pezon (En Plano, Dallas, Frisco, McKinney, Carrollton, Lewisville, Flower Mound)

        January 13th, 2011  

        La proyeccion y tamano excesivo de los pezones, puede ser causa de pena  y verguenza de si mismo, tanto  para hombres como mujeres.  Afortunadamente, la cirugia para la reduccion del pezon es sencilla y no costosa.

        La reduccion consiste en remover, en la forma de un trompo, el exceso de piel  y de pezon y reparar las orillas. Generalmente, recomiendo reducir la proyeccion  del pezon en un 50%, aunque desde luego eso se discute con el paciente. La cicatriz que queda es una linea horizontal en el pezon.  Las cicatrices en  los  pezones son muy discretas; en muchos pacientes las cicatrices son dificiles de encontrar.

        El procedimiento se hace bajo anestesia  local  ( con el gas para relajar, si gusta) si hace un procedimiento nada mas.  Si la reduccion de pezon se lleva a cabo en conjunto con otra cirugia, como aumento de senos o reduccion de pecho masculino, entonces se usa  anestesia general.  La reduccion de pezon cuesta generalmente $600 por un pezon o $1000 por  los dos pezones.

        Para mas informacion, incluyendo fotos de antes y despues, por favor visite www.plasticsurgerydallas.com o hablenos al 469-467-0100.

        Ronald M. Friedman, M.D.

        Director, West Plano Plastic Surgery Center

        Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas

        www.plasticsurgerydallas.com

        IMPLANTES DE SENO DE SILICON: Realmente son seguros? En (Plano, Frisco, Dallas, Lewisville, Carrollton, Allen, McKinney, Southlake, Colleyville)

        November 5th, 2010  

        Implantes de seno de silicones se sienten  mas naturale s y se ondean menos   que los implantes salinos. Pero  son  seguros ?

        Implantes de silicon fueron introducidos  en 1962 y fueron muy populares en los Estados Unidos por tres decadas.  Sin  embargo, en 1992, el FDA (U.S.  Food & Drug Administration) puso restricciones al uso de los implantes de silicon debido a varios reportes de enfermedades autoinmunes (como arthritis, fibromyalgia y lupus) vinculados al gel de silicon.  Como resultado, cuando hice mi residencia en cirugia plastica en el Hospital de Parkland en Dallas de 1992 a 1994, sacabamos mas implantes de los que poniamos.  Por supuesto, habia tambien demandas  de $3 billones en contra de los fabricantes de los implantes de gel de silicon.

        Durante los siguientes 14 anos, el gel de silicon fue la substancia mas estudiada en la tierra.  A  pesar de múltiples intentos para inducir la reacción de gel de silicon en animales de laboratorio, no se logro ninguna reacción inflamatoria.  Los estudios en humanos fallaron en demostrar los anticuerpos de silicon.  El America College of Rheumatology ( el colegio de Reumatologia) (reumatólogos tratan enfermedades del sistema inmune) llego a la conclusión que no había ningún vinculo que relacionara los implantes de seno de silicon con alguna enfermedad del sistema inmune.

        En noviembre del 2006, el FDA retracto su decisión de 1992 y aprobó Allergan(antes Inamed) y Mentor implantes de seno de silicon para uso en los Estados. Unidos. Sin embargo, ha  puesto algunas condiciones para el uso de silicon.  Mientras que para los implantes salinos no hay restricciones de edad, los implantes de seno de silicon solo se pueden usar en mujeres mayores  de 22 anos de edad. Ademas, el FDA  ha estipulado que mientras que los implantes de siicon son seguros, la seguridad de los implantes de silicon que se han reventado no se ha establecido.  Por lo tanto, el FDA recomienda un estudio de resonancia  magnetica (MRI) de los senos a los 3 anos de la operación y cada 2 anos después.  Estos estudios son caros (por lo menos $1500) y no los cubre el seguro medico.  Como resultado, muchas mujeres no se hacen los estudios de MRI después de la operación.

        Dado que los fabricantes ofrecen una garantía de 10 anos , que cubre todos los gastos de cirugía si se llega a reventar un implante de silicon, es buena idea hacerse un MRI antes de los 10 anos de la  expiración de garantía. Es mejor que el fabricante pague el costo de reemplazar el implante reventado que usted.

        Entonces, son seguros los implantes de silicon?  Si los implantes están intactos, el FDA dice que si.  Si se revientan, el FDA dice que “no estamos completamente seguros” .   Yo personalmente no pienso que el gel de silicon sea una substancia mala.  Siempre y cuando usted entienda que la controversia del uso de silicon sigue vigente, pienso que es muy razonable usarlos.  Si los implantes de silicon la  espantan , entonces los implantes de seno salinos siguen siendo una excelente alternativa para la mayoría de las mujeres.

        Para mayor información acerca de implantes de senos, por favor visite:  http://www.plasticsurgerydallas.com/procedures-breast-augmentation.php

        Ronald M. Friedman, M.D.

        Director, West Plano Plastic Surgery Center

        Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas

        www.plasticsurgerydallas.com

        What are high profile breast implants?

        September 16th, 2010  

        Round breast implants come in a variety of sizes.  They also come in different “profiles.”  The profile describes the ratio of the projection of the implant (how far it sticks out) to the diameter of the implant (how wide it is).

        Implant Profile    =             Implant projection              Implant diameter

        Low                                        Small                                      Wide

        Moderate                                Moderate                                 Moderate

        High                                       Large                                      Narrow

        In most patients, a moderate profile breast implant (moderate projection, moderate diameter) provides a natural look.  This is my preference in the vast majority of breast augmentations.

        However, in patients with very narrow chests who desire very large implants, a high profile breast implant (large projection, narrow diameter) may be a reasonable choice, though it may project enough to look a bit artificial.

        The easiest way to understand this is by an analogy to home building in Allen and McKinney.

        Moderate-profile implant: If you have a medium-sized piece of land, then a one story house with 10-foot ceilings will work fine.

        High-profile implant:  If you have a very small lot, then you compensate by building  a small square-footage house that has a 20-foot ceiling in the living room.

        In rare patients who have a wide chest wall and desire a relatively small implant, a low profile breast implant (small projection, large diameter) may be worth consideration.  (This is analogous to a sprawling one-story ranch house with low ceilings.)

        Feel free to call my office at 469-467-0100 for breast implant questions.  (Sorry, I’m actually not qualified to answer any real estate questions.)

        Ronald M. Friedman, M.D.

        Director, West Plano Plastic Surgery Center

        Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas

        www.plasticsurgerydallas.com

        Which are better? Smooth breast implants or textured breast implants?

        August 17th, 2010  

        All saline and silicone gel breast implants have an outer shell that is made from solid silicone.  As the name implies, smooth implants have a smooth, slick surface.  Textured implants have a rough, clingy surface.

        Right after breast augmentation surgery, most implants look too high and too tight.  I joke with patients that their implants will look like decorative shelving for the first couple weeks.  Over the course of the first month or two, the implants typically drop and look more natural, though final results do not occur for about a year.

        Smooth breast implants are “slippery,” and their weight will cause them to fall after surgery.  This is desirable when the implants are below muscle, and the pectoralis major muscle has adequate bulk to hold up the implants.  As a result, smooth implants are used in the majority of routine submuscular breast augmentations.

        Textured breast implants tend to cling to the surrounding tissues, making them more resistant to falling after surgery.  This can be good for women whose breasts and/or chest muscles provide inadequate implant support.  Textured implants placed in a subglandular (above muscle) position are also associated with a mildly lower risk of capsular contracture (excessive firmness of the implants) than smooth implants placed above muscle.

        So which type is better?  I routinely use smooth implants for most breast augmentations.  But I always have textured implants available, since you never know when you might need them.

        Ronald M. Friedman, M.D.

        Director, West Plano Plastic Surgery Center

        Former Chief of Plastic Surgery, Parkland Memorial Hospital, Dallas

        www.plasticsurgerydallas.com