Book Reviews by Joseph M.
Many women claim that leaking silicone-gel has sparked serious illness, including chronic autoimmune disease. In another part of the study, women who had undergone breast enhancement surgery were interviewed.
Removed implants Recently published studies have shown that women with silicone gel-filled breast implants do not have a greatly increased risk of some well-defined autoimmune diseases, which were among the serious health concerns surrounding the devices. These include potentially fatal connective tissue diseases such as scleroderma and lupus erythematosus.
The new studies do not, however, rule out the possibility that a subset of women with implants may have a small increased risk of these conditions, or that some women might develop other immune-related symptoms that don't conform to "classic" disease descriptions.
Nor did the studies address other important safety questions, including implant rupture rates and the incidence of capsular contracture shrinking of scar tissue around the implant, which can cause painful hardening of the breast or distort its appearance.
Answers to these and other questions await the results of new or ongoing studies. Widespread reports of adverse reactions to silicone gel-filled implants and a lack of evidence supporting their safety led the Food and Drug Administration to order the devices off the market in April They remained available only to women in clinical studies, mostly women seeking breast reconstruction after breast cancer surgery.
Saline-filled implants were allowed to remain on the market for all uses. Reasons for New Studies Breast implants had been marketed since the early s--several years before the first medical device law was enacted incharging FDA with regulation of medical devices.
Every year, thousands of American women had implant surgery for augmentation to enlarge or reshape their breasts or for reconstruction following mastectomy removal of the breast to treat breast cancer. Most of the implants consisted of a rubber silicone envelope filled with silicone gel; about 10 percent were filled with saline salt water.
Silicone gel-filled breast implants a 52K JPEG file Saline-filled breast implants a 42K JPEG file Under the law, implants and many other devices already in use were allowed to remain on the market, with the understanding that the agency would at some time ask manufacturers to submit scientific data showing these "grandfathered" products were safe and effective.
FDA requested this information for silicone gel-filled implants in April in response to a growing number of adverse reaction reports that raised safety concerns about the devices.
The data submitted did not prove the devices safe, as required by law, so the agency restricted their use to clinical trials designed to resolve the safety questions.
Because these figures come from all databases, there may be a few duplicate reports. The reports included risks clearly associated with the devices, as well as adverse effects attributed to the implants, but not proved to be linked to them.Browse the WebMD Questions and Answers A-Z library for insights and advice for better health.
The Home of the 4 Hour Investor Grade Business Plan. Faster investor quality documentation using HyperQuestions. If you would like to ask a question, please leave a brief comment/question below and I will respond as soon as I am able.
Please be respectful and use appropriate language, otherwise I cannot publicly post your comment or respond. Surgery may also be required in the case of infection, shifting of the implant, and formation of calcium in surrounding tissues.
Other risk factors may include nerve damage, interference with breast-feeding, and interference in the detection of breast cancer. Breast Implants Essays and Research Papers Instructions for Breast Implants College Essay Examples Title: After reading Case 6 1 Breast Implants discuss What breast implant controversy reveal societys attitudes product safety legal liability manufacturers role regulatory agencies FDA protecting consumers After reading Case 6.
'The Field Of Flight: How We Can Win the Global War Against Radical Islam and Its Allies' by Lt. General Michael T. Flynn and Michael Ledeen Less a memoir or autobiography, this book is a more of a call to action.