'It was made to seem like getting a haircut': Patient says breast implant sales pitch glossed over risks

Breast augmentation is the most popular cosmetic surgery in the world, with 10 million women opting for breast implants during the past decade. We took hidden cameras into the offices of three Toronto plastic surgeons to review how they explain and sell the procedure.
Source: CBC | Health - Category: Consumer Health News Tags: News/Health Source Type: news

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U.S. Food and Drug Administration takes another look at breast implants because of renewed safety concerns over a type of lymphoma.
Source: CBC | Health - Category: Consumer Health News Tags: News/Health Source Type: news
Clinicians encouraged to follow 2019 NCCN guidelines, discuss risks, symptoms as part of patient consent for textured breast implants.Medscape Medical News
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Agency has acknowledged that breast implants may contain materials that affect people's health
Source: The Doctors Lounge - Oncology - Category: Cancer & Oncology Tags: Gynecology, Oncology, Institutional, Source Type: news
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
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