Navigation Links
FDA Focuses on Silicone Breast Implant Safety Studies
Date:8/30/2011

By Steven Reinberg
HealthDay Reporter

TUESDAY, Aug. 30 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel began a two-day meeting Tuesday on silicone breast implants to consider ways to improve the effectiveness of post-approval safety studies.

After being banned for 14 years, the FDA in 2006 approved Allergan and Mentor silicone gel-filled breast implants for breast reconstructive surgery and for breast enlargement in women aged 22 and older.

Such implants had been banned because of concerns about possible links to several diseases, including cancer and lupus.

However, when the FDA lifted its ban on silicone implants, it noted that there was not a lot of data on adverse effects, including what the agency calls "rare events" and "long-term performance." In light of this, the agency required manufacturers to do studies on the implants' safety and performance after their approval.

Study findings announced earlier this year did not show an increased risk of breast cancer or connective tissue disease, although FDA officials noted that longer studies were needed. Although the FDA has also recently cautioned that breast implants might be linked to a higher risk of a rare form of lymphoma called anaplastic large cell lymphoma, officials called those chances slim.

The safety findings were based on preliminary data from six ongoing post-approval studies conducted by Allergan and Mentor, the only two companies that make silicone implants available in the United States.

FDA officials said in a June report that silicone breast implants don't last forever, with as many as half of women with such implants requiring removal within 10 years of the initial surgery.

"The longer a woman has the implants, the more likely she is to experience complications," Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, said in June.

According to the agency's report, one in five women who receives silicone implants to increase the size of their breasts will need to have these devices removed within 10 years due to complications. And as many as half of women who receive implants for reconstruction after breast surgery will need them removed within the same time frame.

Common complications include: hardening of the area around the implant; the need for additional surgeries; and implant removal. Other frequent problems include implant rupture, wrinkling, breast asymmetry, scarring, pain and infection, the FDA said.

These are basically the same complications noted when the two silicone implants available in the United States were allowed back on the market in 2006, the FDA said.

But Allergan and Mentor acknowledged problems with poor patient follow-up, to monitor their health. The situation is "improving," Shuren said in June, but wouldn't say what the rate of follow-up was at that point.

Presently, the FDA recommends that women: follow-up regularly with their doctor, which includes occasional MRIs to detect potential ruptures; pay attention to any changes and notify their health-care provider if they notice any unusual symptoms such as pain, asymmetry or swelling; and educate themselves on the signs and symptoms of complications.

According to FDA estimates, 5 million to 10 million women worldwide have breast implants.

The goal the FDA has set for the next two days for its General and Plastic Surgery Devices Panel is to find ways to better assess the overall performance of silicone implants in "real-world" use.

The FDA plans to update the panel on what is happening with the current studies and to ask for recommendations about how to make these studies more effective. The panel will also be asked for its recommendations on ways to track and study future breast implants after they are approved.

The FDA said it wants to find ways to improve post-approval safety studies and to identify new approaches to mandated studies and surveillance of silicone implants that are likely to yield valuable information on their safety and performance.

This week's review does not include saline implants.

More information

The U.S. Food and Drug Administration has more about silicone breast implants.

SOURCE: U.S. Food and Drug Administration website


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Online Dating Reinvents Itself with the Recent Roll-Out of Teacherhookup.com, a Free Website that Focuses on a Person's Career in Education!
2. Special issue of NeuroRehabilitation focuses on hypoxic-ischemic brain injuries
3. New Cancer-Fighting Strategy Focuses On Signaling Molecules
4. Conference Focuses on Aligning Two Smartest, Most Expensive Operations
5. ACS Webinar focuses on immigration law for scientific professionals
6. Brain cancer: Study focuses on forgotten cells
7. ACS Webinar focuses on drug discovery process for small molecule therapeutics
8. Symposium focuses on patient safety in CT scanning
9. New Medic Monthly Course Focuses on DNR Orders for Patients with Terminal Illness
10. Program focuses on anti-cancer stem cell therapies
11. American Chemical Society Webinar focuses on providing scientific advice to the film industry
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Focuses on Silicone Breast Implant Safety Studies 
(Date:6/23/2017)... ... June 23, 2017 , ... ... and two new videos highlight the importance of correctly using a meat thermometer. ... who has done extensive research on consumer food safety habits. Dr. Bruhn explains ...
(Date:6/23/2017)... FL (PRWEB) , ... June 23, 2017 , ... ... Pinecrest, Florida. This is MD Now’s 28th facility overall and marks the urgent care ... Highway, located one mile North of The Falls shopping mall. The new clinic offers ...
(Date:6/23/2017)... ... June 23, 2017 , ... American Farmer, will feature Chr. Hansen, ... slated to air fourth quarter 2017. American Farmer airs Tuesdays at 8:30aET on RFD-TV. ... pharmacist, founded Chr. Hansen in Denmark in 1874 after a groundbreaking discovery of how ...
(Date:6/23/2017)... IL (PRWEB) , ... June 23, 2017 , ... ... management assistance and financial planning services to communities in the greater Chicago metropolitan ... Association to offer assistance to underprivileged youth in Chicago. , Founded in 1897, ...
(Date:6/23/2017)... ... June 23, 2017 , ... ... the Houston area with access to asset protection and financial planning services, is ... aimed at improving the lives of children with cancer and other chronic diseases. ...
Breaking Medicine News(10 mins):
(Date:6/5/2017)... Cincinnati location of Diplomat Specialty Infusion ... been awarded a Top Workplaces 2017 honor by ... on an employee survey administered by WorkplaceDynamics, LLC, a research ... measures several aspects of workplace culture, including alignment, execution, and ... ...
(Date:6/2/2017)... , June 2, 2017  NxStage Medical, Inc. (Nasdaq: ... care, today announced new findings demonstrating positive biochemical outcomes ... System One™. The data will be presented at ... Madrid, Spain . ... Improve Home Dialysis Network in Europe ...
(Date:5/30/2017)... Holdings, Inc. (NYSE: HRC), will present at the Goldman Sachs ... 13, 2017, in Rancho Palos Verdes, California ... officer, is scheduled to present at 3:20 p.m. Pacific Time. ... http://ir.hill-rom.com/events.cfm . A recorded replay will be available one ... 2017. About Hill-Rom ...
Breaking Medicine Technology: