The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers. The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, […]
FDA Panel: Too early to pull textured breast implants over cancer risk, need more data
A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report. The recommendation comes from the first day of a two-day panel meeting […]
FDA warns J&J, Sientra over lack of post-approval silicone gel breast implant studies
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 […]
FDA ramps up scrutiny of materials in medical devices
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 […]
Sientra plunges on Q4 earnings miss, clouded outlook
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. […]
BD’s Bard pulls all pelvic mesh products from EU market
Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard is removing its women’s pelvic organ prolapse and stress urinary incontinence mesh devices from the European Market, according to a recently posted field corrective action from the company. The Murray Hill, N.J.-based company said that it is “initiating a cease in production and distribution of these devices and a […]
Gynesonics touts fibroid study’s long-term outcomes
A long-term retrospective study of patients treated with Gynesonics’ Sonata uterine fibroid treatment system revealed low rates of surgical reintervention, improved symptom severity and quality of life, the company said today. Patients at the study site in Monterrey, Mexico were treated with the Sonata system, designed to provide incisionless transcervical radiofrequency energy ablation of uterine […]
FDA warns against robot-assisted breast cancer surgeries
FDA has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer. The safety and effectiveness of surgical robots have not been established for use in mastectomies or for surgeries to prevent or treat breast and other cancers, according to the agency, which said […]
Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products
Longer, more extensive studies and a focus on subjective quality of life outcomes were among the top agreed upon recommendations for future trials studying transvaginal mesh implants used for treating pelvic organ prolapse, according to a MedTech Dive report covering the recently held FDA transvaginal mesh advisory panel. While the panelists didn’t vote on any […]
Hologic launches Unifi Analytics mammography suite management software
Hologic (NSDQ:HOLX) said on Monday that it launched its Unifi Analytics software tool intended to enable healthcare facilities to manage mammography device usage and performance. The newly launched system is designed to track installed mammography devices and provide efficiency and accuracy analyses for devices and technologists, the Marlborough, Mass.-based company said. Hologic claims that the web-based […]
Number of cancer cases linked to breast implants soars
FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases […]
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