Thank The FDA For Your Breast Implants
- Posted on: Mar 1 2012
Last month 30,000 French women were urged by their government to have their PIP breast implants removed. The French Ministry of Health fears that the implants’ industrial-strength silicone filler, originally made for mattresses, could leak and cause serious health problems.
So what should American women with breast implants do?
Thank the Food and Drug Administration.
Breast implants are big business. According to the American Society of Plastic Surgeons, last year nearly 300,000 women underwent breast augmentation in the United States. I currently perform over 150 breast implant surgeries per year, by far my most popular procedure.
So what went wrong in France that hasn’t gone wrong here?
The implants under scrutiny were manufactured by the now-defunct Poly Implant Prosthese (PIP), at one time the world’s third largest supplier of breast implants. The company, which went bankrupt and liquidated in 2010, fitted approximately 300,000 women around the world with these devices.
The advice given to women regarding their PIP implants has varied from country to country. France and Venezuela have urged their affected citizens to have the implants removed as soon as possible, while Britain has stated there is no evidence to recommend routine removal in all patients. Women with PIP implants around the world are furious that their government’s health ministries have allowed these unsafe implants to be used in so many people.
Here in the U.S., two companies manufacture the bulk of breast implants, Allergan and Mentor. The saline and silicone implants from both companies have stood up to the rigorous testing standards of the FDA.
Interestingly, PIP submitted their saline breast implants for FDA approval, but was rejected in March 2000. Specific reasons behind the FDA denial are unclear, but a study published in Plastic and Reconstructive Surgery by Stevens, et al., may provide a big clue. They discovered PIP saline implants had 3.5 times the rupture rate of Mentor saline implants. When an unacceptably high rupture rate is combined with contaminated silicone many complications can occur, including infection, inflammation, scar tissue, and possibly even cancer.
PIP silicone breast implants were never really used in the United States. If you had your breast augmentation in the U.S., it’s highly unlikely that you have these defective devices.
However, if you had your surgery overseas, then it’s a good idea to obtain your breast implant information from your surgeon. If your implants were manufactured by PIP, it may be a wise decision to switch them out for Mentor or Allergan implants.
If you’re thinking about undergoing a breast augmentation, don’t be afraid of silicone. Silicone breast implants are quite possibly the most studied medical device in the history of the world, and the FDA has deemed them safe for use.
Make sure you consult with a surgeon certified by the American Board of Plastic Surgery and a member of the American Society of Plastic Surgeons. Discuss the pros and cons of saline versus silicone. Recent surveys have found that, while silicone breast implants account for 60% of sales, a significant number of patients are still undergoing augmentation with saline. Silicone implants look and feel more natural than saline, but a broken silicone implant is harder to detect than a broken saline implant.
Studies show that over 90% of women with breast implants are satisfied with their outcomes. Still, I turn down one out of every five women who consult for breast augmentation, usually because I believe it’s not right for them.
Breast implants aren’t for everyone.
But the implants used in the United States are safe.
Tagged with: breast augmentation, breast implants, FDA, PIP, silicone
Posted in: Plastic Surgery News