At the office of Baltimore breast augmentation surgeon Janet P. Woodyard, M.D., plastic surgery candidates can learn about the safe use of silicone gel breast implants. Last month, the U.S. Food and Drug Administration (FDA) re-confirmed its position on silicone-gel breast implants, stating that they remain “safe and effective for their intended use.” However, the FDA is looking for ways to develop a uniform follow-up process for breast augmentation patients in order to improve research and documentation.
As many of Dr. Woodyard’s Baltimore breast augmentation patients know, the FDA placed a ban on silicone-gel implants in 1992; then, after improvements were made to the devices and clinical trials failed to show a connection between the implants and autoimmune disease, the agency re-approved them for use in 2006. As a condition of the approval, the FDA required major implant manufacturers Mentor and Allergen to conduct a 10-year study, respectively, of their implants’ performance.
Nationwide, it seems that many breast augmentation patients – even official study participants – have been lost in the follow-up process. Mentor reports three-year data for only one out of every five women in its study, while Allergan has two-year data for three out of every five, according to the FDA. The agency is giving the manufacturers one year to improve the follow-up process.
One expert that participated in a two-day meeting convened by the FDA to discuss breast implant follow-up said it best. “You could have the most well-meaning company that wants to do a good study, but if the patients don’t want to participate, the study won’t be completed,” Dr. William Maisel of the Center for Devices and Radiological Health told reporters. After all, women who are happy with their surgery results may be less likely to participate in post-market studies or even return for checkups. If anything, this is a testament to the “natural” feeling of enhancement that breast implants offer.
At the Baltimore breast augmentation practice of Dr. Woodyard, women are instructed to attend follow-up appointments in the weeks following surgery. The office urges them to contact Dr. Woodyard immediately if they experience any problems.
