FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data about Quality of Life, Connective Tissue Symptoms, Rupture Rates per Patient, and Other Complications

January 5, 2012 Dr. Jeffrey Shuren, Director Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD 20993 RE: FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data about Quality of Life, Connective … Continue reading

Laser Liposuction—Weight Loss Tool or Scam?

As American waistlines have expanded, the attraction of a quick weight loss fix has increased. Diet and exercise are the key to safe weight loss, but for many of us, the results are discouraging. As a result, liposuction is the third most commonly performed cosmetic procedure in the United States, after breast augmentation and nose reshaping. However, the procedure can result in severe though rare complications including infection, cardiac arrest, blood clots, excessive fluid loss, fluid accumulation, damage to the skin or nerves, seizures, bruising, swelling, and damage to vital organs. Plastic surgeons often present laser liposuction as a safer, effective alternative which works by inserting a laser beneath the skin and liquifying fat. But does it work and is it really safe? Continue reading

2011 FDA Update on Silicone Gel Breast Implant Safety: Many Unanswered Questions

The FDA released a new report on June 22, 2011 showing that breast implants cause many complications and often need to be removed, but that if “used as directed” (including regular MRIs) implants are “reasonably safe.” However, the FDA admits that we don’t have as much safety information as we need, and that the implant companies haven’t done a very good job of doing safety studies. Continue reading

The Wrinkle in Facial Injections and Implants: Safety Questions

In the eternal search for eternal youth, some new technique or product is always being touted as the next best thing. Women and men seek out long-lasting non-surgical procedures that will reduce wrinkles and make them look younger or better. There are many different types of facial injections (some permanent and some temporary) and implants, each having a variety of brand names. We will discuss five of the most popular of these treatments, and in terms of safety concerns, the news is not especially good. Continue reading

Breast Implants: A Research and Regulatory Summary

In the past decade, there has been a dramatic increase in breast implant surgery, yet this does not necessarily mirrored by a similar increase in the number of women with breast implants. Many women are replacing old implants that have broken or caused problems. This summary examines the role of the FDA in safety research, the types of breast implants, the frequency of local complications, increased risk of autoimmune and connective tissue diseases, cancer, lung disease, and suicide, impact on general health and quality of life, and the hidden costs associated with breast implants. Continue reading

Nips, Tucks, and…Designer Vaginas?

Variations in the natural female form used to be accepted, even celebrated. Increasingly, however, these variations are seen not as assets, but as problems to be taken care of by plastic surgeons. Amongst many cosmetic surgeries, “genital rejuvenation” is growing in popularity. Does this procedure work, and what does the future hold for such genital plastic surgeries? Continue reading