"With associated complications such as these, I find it unbelievable the FDA would claim silicone gel-filled breast implants are safe and effective."
Newport Beach, California (PRWEB) June 30, 2011
The California product defects attorneys of BISNAR | CHASE (BestAttorney.com) say they believe the recent FDA report offering updated safety information about silicone breast implants puts women at risk of health complications due to questionable data upon which the report is based, as well as the confusing nature of the information contained within.
The FDA posted a summary regarding updated safety information for Silicone Gel-Filled Breast Implants1 at its website last week, stating that when the agency allowed these types of breast implants back on the market in November 2006, it required the manufacturers of the implants to "conduct follow-up studies to learn more about the long-term performance and safety of the devices."
According to the report, the updated FDA information is based on analyses of post-approval studies conducted by Allergan and Mentor – manufacturers of silicone gel-filled breast implants – as well as its own data and information about silicone breast implants found in scientific publications.
Brian Chase, product defects expert and partner at BISNAR | CHASE, says he has serious concerns about the FDA's updated safety information.
"I find it absurd that the FDA would include information provided by manufacturers of silicone breast implants in its study, and then rely on that information to develop its updated safety findings," said Chase. "This is a perfect example of the fox guarding the henhouse. What's more, in the report, both manufacturers have admitted to the FDA the difficulties in following women who have received silicone gel-filled breast implants."
Chase, a 17-year product defects attorney who has represented clients due to medical device defects, goes on to say he has real problems with some of the conclusions the report draws – one, in particular, that states "preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis."
Chase says that immediately following this verbiage, the report states that in order to rule out these and other rare complications, studies would need to enroll larger groups of women and for longer periods of time than the ones that have been conducted to this point, and that the FDA is holding an expert advisory panel in the next few months to discuss how post-approval studies on breast implants can be more effective.
"In my opinion, it's negligent and reckless for the FDA to publish what appear to be premature findings before adequate numbers of women have been analyzed for appropriate lengths of time, especially when independent studies have shown there could be a connection between silicone gel-filled implants and ongoing immunogenicity of silicon2."
Finally, Chase says that overall, the FDA report is contradictory, confirming that silicone gel-filled breast implants are safe and effective when used as intended, but then stating that they are also associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture, and also with some women experiencing breast pain, wrinkling, asymmetry, scarring and infection.
"With associated complications such as these, I find it unbelievable the FDA would claim silicone gel-filled breast implants are safe and effective," said Chase.
1 FDA, Silicone Gel-Filled Breast Implants: Updated Safety Information, June 22, 2011, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm259825.htm
2 Admin, Study Shows Proof Systemic Inflammatory Reaction to Silicone Breast Implants, June 10, 2011, http://nutritiondietnews.com/study-shows-proof-systemic-inflammatory-reaction-to-silicone-breast-implants/854249/
About BISNAR | CHASE
The BISNAR | CHASE California Product Defects Attorneys represent people who have been very seriously injured or lost a family member due to an accident, a defective product such as a medical device, or negligence throughout California and the U.S. The law firm has won a wide variety of challenging serious injury defective product cases against a number of Fortune 500 companies. For more information, please visit BestAttorney.com.