The Plastic Surgery 101 Blog - www.robolivermd.com

SAFE: FDA re-confirms safety of silicone gel breast implants

Dr. Rob Oliver — Fri, 15 Jul 2011 14:29:05 +0000

In a not unexpected conclusion, yesterday the United States Food & Drug Administration re-affirmed their 2006 decision to reintroduce silicone gel breast implants into the United States market for cosmetic indications. In statements from the FDA, they explained that no new information has arisen to question the safety or efficacy of the devices for intended use. As has been discussed on Plastic Surgery 101 a number of times, this is not really news and has been accepted world-wide for a number of years now. Hopefully this statement from FDA heralds the availability of the new form stable “gummy bear” silicone implants here in the United States which have been available everywhere else for almost 15+ years.
Breast augmentation remains the most popular cosmetic surgery in the U.S., with nearly 300,000 women undergoing it last year. According to the American Society of Plastic Surgeons (ASPS), more than 70,000 others received implants for breast reconstruction.

The most disappointing finding was that only ~60% percent of women enrolled in a 1,000-patient study of one manufacturers implants are still accounted for after eight years. A larger study of 40,000 women conducted has lost nearly 80 percent of its patients after just three years. Diana Zuckerman of the National Research Center for Women and Families, one of the most prominent (and persistent) anti-implant activists, cried foul and suggested that most medical journals would not publish the studies cited by the FDA because of the missing data. I’d agree with her, but for different reasons. She’s implying safety issues exist (which they don’t by and large), while I’m more interested in outcome data to understand how to reduce re-operations.

Why the relatively poor follow up in the FDA trials?

Dr. Phillip Haeck, president of the American Society of Plastic Surgeons (ASPS)sums it up saying that, “When women are happy with their implants they tend to feel that a regular follow-up is pointless – it becomes a nuisance and an unnecessary expense”. I’d agree 100% with that.

It also begs the question of what exactly are we trying to demonstrate with the FDA follow up studies. There is overwhelming world-wide information that suggests safety at this point. It would be nice to have a little more data on longevity so as to better counsel patients on when to consider routine exchange with prior devices, but as we’re on the cusp of a major design change in the polymers that make the implant almost impossible to rupture (the “gummy bear” form stable devices) we’re going to quickly lose interest in exhaustively studying older devices. This kind of technology advance has always created problems about making conclusions with medical devices, as you end up comparing apples to implants (bad pun alert).

Something Old & something new – Is subfascial breast augmentation the choice for you?

Dr. Rob Oliver — Wed, 03 Nov 2010 02:03:02 +0000

In the last few years, an alternative to traditional implant position has been described. As opposed to the simple over/under the pectoralis muscle decision, a technique which places the implant over the muscle but under the muscle fascia (covering tissue) has interesting properties that offer several benefits.

# Subfascial placement prevents the “bolted on” appearance often caused by the submuscular placement, offering a more natural slope to the breast similar to traditional subglandular implant placement.
# Has a lower rate of visible wrinkles or “rippling” then the pure subglandular position
# Less disruption of the patient’s anatomy than the submuscular or partial submuscular positions, as the pectorlais muscle is not released off of the chest wall.
# Significantly less discomfort early after surgery. Generally, patients can return to work after a 2-3 days, and are able to resume workouts early on.
# Prevents the muscle “animation” of the implant that is often visible after submuscular placement in extremely active or thinner individuals.

In patients with enough tissue to consider this type of surgery, I am increasingly recommending this approach to patients considering breast augmentation.

High risk breast cancer patients benefit from preemptive mastectomy

Dr. Rob Oliver — Thu, 02 Sep 2010 21:52:40 +0000

A new study of women with the “breast cancer gene ” (BRCA1 & BRCA2) confirms that pre-emptive surgery to remove the breasts and ovaries in women with BRCA genes can sharply reduce the risk of contracting cancer and dying.

Welcome to the new Blog!

Dr. Rob Oliver — Sun, 29 Aug 2010 15:46:22 +0000

Welcome to the new blog! This represents a new beginning for me. In 2006, I started Plastic Surgery 101 on Google and it went on to become one of the most trafficked Plastic Surgery related blogs in the world. With our new practice website for Plastic Surgery Specialists, I’ve started a new blog to more tightly coordinate with my practice and produce content specific topics that I think people will enjoy.

Stay tuned for updates!
Dr. Rob Oliver Jr.