Breast implantation seems to be an effective treatment for breast cancer. However, there are certain guidelines associated with it. The U.S. Food and Drug Administration has unveiled a report with the latest additions of clinical and scientific information for silicone gel-filled breast implants .It has also stated the initiatory safety data from studies undertaken by manufacturers as a term of their November 2006 approval.
The report affirms that silicone breast implants are supposedly safe and efficient, but there are certain risks accompanying them. As per the study, women need to note that breast implants do not extend to the entire life cycle. Longer use may tend more towards complications. 1 out of 5 patients who have undergone augmentation may need to remove the implants within 10 years of operation. In the case of breast reconstruction 1 in 2 patients may have to remove the implants after 10 years.
One of the main complaints and effects of the process seem to be capsular contracture, reoperation and implant removal. There are also problems of implant rupture, wrinkling, asymmetry, scarring, pain and infection. The problems that were present in women who were given breast implants at the time of affirmation look apparently similar to difficulties observed at present. Silicone gel-filled breast implants may not necessarily cause breast cancer but may lead to rheumatoid arthritis or other connective tissue diseases.
The study includes the post-approval analysis that includes preliminary safety information. The investigation was conducted by 2 breast implant manufacturers Allergen and Mentor. FDA stamped its approval for the silicone gel-filled breast implants in November 2006 for breast augmentation in women above the age of 22. All women were approved of breast reconstruction.
These studies are a part of a condition placed by FDA to detect the safety and long-term function of the devices. The two manufacturers have reported the problems faced by women who have received the aforementioned implant. There are negotiations going on for tackling the difficulties and boost patient involvement and follow-up.
“The FDA will continue to monitor and collect safety and performance information on silicone gel-filled breast implants, but it is important that women with breast implants see their health care providers if they experience any symptoms. Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems,” explained Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.
The FDA has placed certain recommendations for medical professionals and women who have received silcone gel-filled breast implants. Firstly women need to follow-up with doctors and get timely MRIs done to identify silent rupture. Secondly, they should be aware of the effects of implants that are mentioned above.
Any changes that seem unusual should be noted and reported to professionals including the implant manufacturer and Medwatch. Women who have agreed to the manufacturer-sponsored post-approval study should continue to stay in touch and participate. These studies educate women on long term complications of the devices. The report strives to enlighten all women who have chosen or will choose to go in for silicone gel-filled breast implant. The company has also restructured its website to include adequate knowledge on silicone gel and saline-filled breast implants.
The FDA is slated to hold an expert advisory panel in the coming months to have a discussion on the effectiveness of post-approval breast implants.