Woman left with 'bubble boobs' after the plastic surgery she spent her life savings on went wrong 

Jacqueline Harvey, 23, from Brisbane, spent five years saving for breast augmentation but immediately regretted her decision when she looked in the mirror, last year.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news

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This study is an ongoing 10-year study with 103 subjects undergoing augmentation or primary reconstruction with BellaGel implants. To assess effectiveness, rupture and capsular contracture rates were measured and Kaplan-Meier analysis was performed. Paired t-test was used to determine significant changes in breast dimensions. Safety assessment included evaluation of all adverse reactions. Average follow-up period was 5.9 years. Implant rupture and capsular contracture rate through 4 years were 0 percent and 2.3 percent, respectively. Capsular contracture rate was lower in the augmentation group (0.8%) than in...
Source: Journal of Plastic Surgery and Hand Surgery - Category: Surgery Tags: J Plast Surg Hand Surg Source Type: research
FDA busted two manufacturers of silicone gel-filled breast implants this week for failure to comply with post-approval study requirements. The agency sent warning letters to Irvine, CA-based Mentor Worldwide, a unit of Johnson &Johnson, and to Santa Barbara, CA-based Sientra for deficiencies in each company's post-approval study for silicone breast implant approvals. Breast implants have been a source of contention between patient advocacy groups, industry, and FDA for decades. Implants were banned from the U.S. market from 1992 to 2006, and the devices have been the cause of an over...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news
The U.S. Food and Drug Administration has issued warning letters to Sientra Inc and a Johnson&Johnson unit for failing to comply with the post-approval study requirements for their breast implants.
Source: Reuters: Health - Category: Consumer Health News Tags: healthNews Source Type: news
The Food and Drug Administration is taking another look at breast implants because of renewed safety concerns.
Source: NYT Health - Category: Consumer Health News Authors: Tags: your-feed-science Implants Breasts Medical Devices Breast Cancer Women and Girls Plastic Surgery Autoimmune Diseases Allergan Inc Food and Drug Administration Mentor Worldwide LLC Sientra Inc. Source Type: news
The FDA today released warning letters it sent to Johnson &Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants. The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies of the devices to maintain appropriate data on the long-term safety and potential risks associated with the devices that premarket trials cannot foresee. In its letter to J&J’s ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Women's Health johnsonandjohnson Mentor Worldwide Sientra Source Type: news
AbstractBreast augmentation with various injectable materials has been performed for decades. Aquafilling was developed in 2005 as soft tissue filler for facial contouring and recently its use for breast augmentation has gained speed in several countries. Its declared composition is 98% water and 2% copolyamide. Although not approved by the U.S. Food and Drug Administration, the procedure is increasingly applied in Turkey. Thus, familiarity with specific imaging findings and complications of this entity is important for the correct diagnosis. Possible migrated material should especially be sought for when reporting these c...
Source: European Journal of Plastic Surgery - Category: Cosmetic Surgery Source Type: research
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
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