Safety concerns raised over breast implants

Some makers of textured implants did not carry out adequate tests, an investigation finds.
Source: BBC News | Health | UK Edition - Category: Consumer Health News Source Type: news

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In a recentletter, the FDA encouraged health care professionals to learn more about the association between all breast implants —regardless of filling or texture—and anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin lymphoma.
Source: JAMA - Category: General Medicine Source Type: research
(Image by Michael Longmire on Unsplash) The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ &ld...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Blog Cardiovascular Featured Food & Drug Administration (FDA) Implants Materials Testing Metal-on-Metal News Well Oncology Orthopedics Regulatory/Compliance Replacement Heart Valves Stents Surgical Women's Health ani Source Type: news
As part of its effort to modernize its regulatory programs, FDA has turned its attention to materials used in medical devices.  The agency released a statement Friday from Commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health that addresses recent advances in materials science and how these advances have impacted the safety of medical devices. "Materials used in today's medical devices vary as widely as the devices themselves—whether the material is metal, plastic, silicone, an animal-derived product or some combination of these," Got...
Source: MDDI - Category: Medical Devices Authors: Tags: Materials Regulatory and Compliance Source Type: news
Longitudinal data used from over 220,000 nurses Related items fromOnMedica Breast cancer rate falls with decline in HRT use Only a third of women with regular bloating would see their GP Women consider legal action over cancer link breast implants Some irregular cervical lesions could be monitored rather that treated immediately Women who were not offered breast screening have been contacted
Source: OnMedica Latest News - Category: UK Health Source Type: news
A fourth-quarter earnings miss and the uncertainty around an upcoming FDA advisory panel meeting on breast implants sent Sientra (NSDQ:SIEN) shares down precipitously today. The Santa Barbara, Calif.-based medical aesthetics company’s losses widened 38.1% to -$24.6 million, or 86¢ per share, on sales growth of 71.9% to $19.0 million for the three months ended Dec. 31, 2018, compared with Q4 2017. Analysts on Wall Street were looking for losses of -68¢. Full-year losses were up 29.0% to -$82.6 million, or -$3.25 per share, on sales growth of 86.4% to $68.1 million compared with the prior year, Sientra said. ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic MassDevice Earnings Roundup Wall Street Beat Women's Health Sientra Source Type: news
ConclusionsThe mammography practice varies across the five countries. We found country-specific traits related to mammography image acquisition, patient-centered care and quality management procedures. The lack of evidence-based knowledge suggests the importance of well-designed studies on these topics. The variability found in this pilot study encourages radiographers to question their own practice and teachers to review and revise the training programmes. Validation in larger studies including more countries is needed.
Source: Insights into Imaging - Category: Radiology Source Type: research
The number of cosmetic procedures performed in the U.S. has climbed steadily over the past five years.
Source: WebMD Health - Category: Consumer Health News Source Type: news
Erika Ritschard, from Long Beach, Mississippi, had her silicone implants removed after five years because she said they were ageing her prematurely and wrecking her health.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
MONDAY, March 11, 2019 -- More Americans than ever are trying to reshape their bodies with breast and butt implants, liposuction and " thigh lifts, " a new report shows. Almost 18 million cosmetic procedures were performed in the United States in...
Source: Drugs.com - Daily MedNews - Category: General Medicine Source Type: news
We are frequently asked does health insurance pay for Essure removal? Essure was first approved in 2001. At first not many women opted to have the Essure procedure. As doctors became more comfortable offering Essure and as the public became aware Essure was tubal ligation alternative, more women chose to use Essure for permanent birth control (sterilization). Sterilization is intended to be permanent. Research has shown that a significant number of women will regret their sterilization and desire to have another baby. Some of these women will consider in-vitro fertilization and some will consider surgical reversal of steri...
Source: Tubal Reversal Blog - Category: Reproduction Medicine Authors: Tags: Essure removal health insurance pay Source Type: blogs
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