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24.05.2014
WASHINGTON — Federal health officials say the latest data on silicone breast implants show they are relatively safe, despite frequent complications that lead about one in five women to have the implants removed within ten years. A Food and Drug Administration report issued Wednesday is the agency’s first safety assessment of the implants since regulators returned them to the market in 2006. The FDA pulled silicone implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness. But the agency returned the implants to the market five years ago after most studies failed to find a link between silicone breast implants and those diseases.
The approval came with conditions, including a requirement that the companies complete studies on women who have received the implants.
But industry critics point out that most of the studies are incomplete, and many women have already dropped out. For example, only 58 percent of women enrolled in a 1,000-patient study of Mentor’s implants are still accounted for after eight years. The most common side effect remains scar tissue which hardens around the implant, warping the shape of the breast. Based on the company data, FDA says 20 to 40 percent of patients who have implants for cosmetic reasons will need another operation to modify or remove them within eight to 10 years. Quis autem vel eum iure reprehenderit qui in ea voluptate velit esse quam nihil molestiae consequatur, vel illum qui dolorem? If you're dreaming of a curvy figure, but concerned about the risks of breast implants, there's good news!
Breast implants are medical devices that are used to augment breast size or to reconstruct the breast following mastectomy or to correct a congenital abnormality. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Patients and plastic surgeons say the silicone-filled implants look and feel more real than saline versions.
Two larger studies of 40,000 women, conducted by both Allergan and Mentor respectively, have each lost a significant number of patients after just two to three years.
Diana Zuckerman of the National Research Center for Women and Families said most medical journals would not publish the studies cited by FDA because of the missing data.


Other problems include implant rupture, wrinkling, and lopsided appearance, according to the report.
For women with implants for breast reconstruction, the number is even higher, at 40 to 70 percent. Please download the latest version of the Google Chrome, Mozilla Firefox, Apple Safari, or Windows Internet Explorer browser.
Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). Approximately 5 to10 million women worldwide have breast implants.According to the American Society of Plastic Surgeons National Clearinghouse of Plastic Surgery Procedural Statistics, there were 296,203 breast augmentation procedures and 93,083 breast reconstruction procedures performed in the United States in 2010. Approximately half the procedures used saline-filled implants and half used silicone gel-filled implants. This report provides a clinical update on the two silicone gel-filled breast implants available in the U.S.
Of these, the most complete data set to date comes from the Core Studies.The Allergan Core Study enrolled 715 patients and the Mentor Core Study enrolled 1,008 patients. Longer term follow-up is available for the Allergan Core Study participants because the study began enrolling patients approximately 20 months before the Mentor Core Study.Both companies enrolled more than 40,000 women in their Large Studies.
In these studies, Allergan has collected 2-year data for 60% of participants, and Mentor has collected 3-year data for 21% of participants.The local complications observed in the silicone gel-filled breast implant post-approval studies are consistent with complications noted at the time of approval.
The most common complications and adverse outcomes include capsular contracture, reoperation, and implant removal.
Other complications include implant rupture, wrinkling, asymmetry, scarring, pain and infection. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience local complications. Collection of these data will help characterize the known breast implant-related problems and improve data analysis.Overall, the adverse event reports submitted to the FDA are consistent with the results from the premarket and post-approval studies. No new outcomes or complications were reported through December 2010, except for rare reports of Anaplastic Large Cell Lymphoma (ALCL).Literature ReviewThis report summarizes the epidemiologic literature published in peer-reviewed journals since 2005 on the clinical safety and effectiveness of silicone gel-filled breast implants.
It focuses on outcomes that have not been addressed to date in post-approval studies.Most women reported high levels of satisfaction with their body image and the shape, feel and size of their implants. There is no apparent association between connective tissue disease and silicone gel-filled breast implants, although most of the available studies have limitations.


Silicone gel-filled breast implants are not associated with an increased risk of breast cancer. There is no evidence that suggests untoward effects of silicone gel-filled breast implants on pregnancy or fertility. Furthermore, current evidence does not support an association between mothers with breast implants and difficulty with breast feeding or adverse health events in their children.Recent case reports have suggested that women with breast implants may be more likely to be diagnosed with anaplastic large cell lymphoma (ALCL). Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.The longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes. Women with breast implants will need to monitor their breasts for local complications for the rest of their lives.The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement).
Other frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others.
Although routine replacement is not necessary, many women will need additional surgery to modify, remove, or replace their implants.There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems.
Local complications and adverse outcomes include capsular contracture, reoperation, removal, and implant rupture. Many women also experience breast pain, wrinkling, asymmetry, scarring, and infection.Continue to receive routine follow-up with your physician.
The longer you have your implants, the more likely it will be for you to have them removed.If you have enrolled in an Allergan or Mentor post-approval study, continue to participate.
Your contributions provide data that are used to evaluate how new surgical techniques, patient characteristics, and implant characteristics influence the cosmetic and health outcomes of patients undergoing breast implantation.Screen for silent rupture using MRI. Key sections of this website describe the risks of breast implants, the questions women should ask their doctors before getting breast implants, and what women should expect during the surgical procedure and recovery.Developed a new Breast Implants Complications Booklet for patients. It is available on the FDA website.Requires silicone gel-filled breast implant manufacturers to update their labeling each time the data is reanalyzed. The most current Labeling for Approved Breast Implants is available on the FDA website.ConclusionBased on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled.
Manufacturers and physicians should continue to provide balanced and up-to-date information to women considering breast implants to help inform their decisions.



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Comments »

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24.05.2014 | 20:46:39
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24.05.2014 | 19:19:50
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24.05.2014 | 14:32:10