What have been some of your Experiences in Practice?
I began practice in a large Multi-specialty group practice in Champaign, IL in 1990. Then I transitioned to a Community Hospital based practice in Peoria, IL in 1999 followed by a small group practice in Austin TX in 2012. I find myself now in a private practice on Long Island where I specialize in Breast and Body procedures while the practice founder specializes in Facial cosmetic procedures.
I hope my patients and readers/viewers of this blog can be informed from my perspective of 30 years of experience; and with that I hope I can inform our viewers about some the important topics, questions and controversies in Body Plastic Surgery today.
This month my wife and I will celebrate 30 years of marriage. She has been by my side since my Plastic Surgical Residency; she knows all the ups and downs of the Plastic Surgeon experience. She is a nurse and has been a patient, so she brings a great perspective as well and she’ll occasionally share that with our readers/viewers.
This month I will focus on Breast Surgery, specifically Breast Augmentation. While the basics of the procedure have remained the same, there have obviously been a great number of changes, advancements and improvements over the past 30 years as well.
In this first installment let’s focus on the Breast Implant
Shortly after I started in practice the FDA moratorium on the use of silicone gel implants was imposed and the only device available to Plastic Surgeons was the Saline Implant. A saline implant is a device with a silicone rubber shell, the same as a gel implant. It is filled with physiologic saline, essentially intravenous fluid which is mostly water. This device is useful but has some inherent limitations in my opinion.
First it contains a valve through which the saline is added; this can be a point of weakness. Second, the fill material, in this case, Saline, is mostly water which is not a particularly cohesive (sticky or gel-like) fluid. This can lead to rippling and wrinkling of the implant shell. This can be visible and or palpable; neither of which is desirable.
Second there is a lot of misinformation about implant lifespan. Some studies indicated that the average lifespan of a Saline implant was in the 10-year range; this subsequently morphed into the idea that implants should be replaced every 10 years; this is not correct. If you are not having any problems with your implant, then simply because it is 10 or more years old does not meant that it needs to be replaced. If the device is intact and not giving you physical or appearance concerns, then you would not need to have it replaced no matter its age.
In 2006 the FDA approved the manufacture and sale of Silicone Gel Implants once again. Silicone gel is a polymer of the Silicone molecule. It is produced as a viscous type of gel. The manufacturing process can change the “cohesivity” of the gel-making them stickier or Jell-o like. I believe it has a more natural, softer feel to it than the Saline device. In general, although they can and do ripple, the gel implant has less rippling which can almost be eliminated as the cohesivity of the device is increased. This also makes the implant stiffer, but not unnaturally so, I feel.
A gel implant should have a longer life span than a Saline device, lasting in a 20-30-year range. They should be monitored with an MRI exam periodically to rule out a silent rupture. As the preponderance of the gel is going to sit inside the capsule, a failure of the implant may not be appreciated by the patient; the MRI is the most accurate means we have of evaluating the status of implant integrity. Getting an MRI of the Breast every 7-10 years is reasonable.
All implants are warranted by the manufacturer; details are available on the manufacturers’ web sites:
A word about the implant related cancer that is appropriately concerning breast implant patients:
(taken from info on the American Society of Plastic Surgeons website)
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon and highly treatable type of lymphoma that can develop around breast implants. BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. The current lifetime risk of BIA-ALCL is estimated to be 1:2,207-1:86,029 based upon variable risk with different manufacturer types of textured implants. Since the initial case report in 1997, ASPS now recognize approximately 293 cases in the US and a total of 779 worldwide as of September 3, 2019.
Most of the patients who have developed BIA-ALCL receive an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule. Continued follow-up after any breast implant surgery is suggested and important for patient health, but patients who notice pain, lumps, swelling, fluid collections or unexpected changes in breast shape, including asymmetry, should contact their plastic surgeon. In most cases, women diagnosed with BIA-ALCL observed changes in the look or feel of the area surrounding the implant greater than one year after their initial surgical sites were fully healed, and on average eight to ten years after receiving textured implants.
The July 24, 2019 FDA website update acknowledges that while it remains difficult to determine the exact number of BIA-ALCL cases, after thorough review there have now been 573 unique confirmed cases worldwide which included 33 known deaths. Majority of these cases involved a textured device at the time of BIA-ALCL diagnosis or demonstrate a clinical history of a textured device at some time prior. The update also confirms that both silicone gel and saline implants have been reported in cases of BIA-ALCL. The FDA noted that a majority (481 reports) of cases were associated with Allergan breast implants and therefore requested a voluntary recall of Allergan Biocell surface devices within the US. Allergan subsequently responded with a worldwide recall of their Allergan Biocell textured implants and expanders.
I hope this has given you all some useful information and an appetite to read and or view my subsequent posts. Have a great week!
James M. Sheridan, M.D.
Marotta Plastic Surgery Specialists