The FDA this week released new labeling requirements for Bayer’s (ETR:BAYN) controversial Essure and other permanent hysteroscopically-placed tubal sterilization implants. Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities […]
Women's Health
Judge halves $4m pelvic mesh verdict against Johnson & Johnson
A Georgia federal judge yesterday cut a $4 million verdict in a defective pelvic mesh lawsuit against Johnson & Johnson‘s (NYSE:JNJ) Mentor business unit in half, applying a statutory $2 million damages cap. Chief U.S. District Judge Clay Land rejected a bid to overturn the verdict, but reduced the damages by $2 million. Judge Land […]
CERN researcher’s fertility app is as good as oral contraceptives, condoms
Natural Cycles, the fertility app developed by former CERN particle physicist Elina Berglund, is reportedly as effective at preventing pregnancy as oral contraceptives or condoms, boasting a 99.5% efficacy rate. Berglund began working on the app while she was still at the particle physics laboratory in Geneva, she told Wired. Get the full story at […]
Study finds high rate of overdiagnosis from mammograms
(Reuters) – Better treatment and not earlier detection with screening mammography may be the reason rates of death from breast cancer have declined in recent years, according to controversial results from a large U.S. database study. In addition, the research team reports in The New England Journal of Medicine, “women were more likely to have […]
Surgery during pregnancy carries low risk
(Reuters) — Surgical procedures during pregnancy are generally safe, new research indicates. “Clearly, surgery during pregnancy should only be considered if absolutely necessary,” said Dr. Paul Aylin, study co-author and an epidemiologist at the Imperial College London in England. But when expectant mothers do need to undergo surgery, “the information provided in our analysis may give […]
Viveve wins FDA 510(k) for its Viveve System
Viveve (NSDQ:VIVE) said today it won FDA 510(k) clearance for its Viveve System, now cleared for use in general surgical procedures for electrocoagulation and hemostasis. The company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. “FDA 510(k) clearance for the Viveve System represents a major milestone in our efforts to […]
Boston Scientific loses bid to toss $19m pelvic mesh loss
Boston Scientific (NYSE:BSX) yesterday lost its bid to overturn an $18.5 million loss in a product liability lawsuit brought by a quartet of women alleging that its Obtryx pelvic mesh caused their injuries. A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later […]
Allergan wins FDA nod for Natrelle Inspira breast implants
Allergan (NYSE: AGN) said last week that it won FDA pre-market approval for its Natrelle Inspira cohesive breast implants for women undergoing breast reconstruction, augmentation or revision surgery. The newly cleared Natrelle Inspira implants combine both a high gel fill ratio and the company’s cohesive gel to create a customized shape, the company said. “Natrelle […]
FDA approves Bayer’s Kyleena IUD
Bayer (ETR:BAYN) said yesterday that it won FDA approval for its hormonal contraceptive device, Kyleena, to prevent pregnancy for up to 5 years. The German company said the long-acting reversible contraceptive (LARC) is due to hit the market next month. LARCs are an increasingly popular form of birth control, including intrauterine devices like Kyleena. Bayer’s […]
Plaintiff’s loss overturned in Boston Scientific pelvic mesh lawsuit
The plaintiff in the 1st pelvic mesh lawsuit to go to trial against Boston Scientific (NYSE:BSX) won a new trial yesterday when a Massachusetts appeals court overturned a 2014 verdict dismissing the case. Diane Albright alleged that the Pinnacle mesh implanted to treat her pelvic organ prolapse was improperly designed and caused her injuries after it was […]
Viveve hits the market Down Under
Viveve (NSDQ:VIVE) said today it it won regulatory clearance from Australia’s Therapeutic Goods Administration for its Viveve non-surgical treatment for post-partum laxity of the vaginal introitus. The Sunnyvale, Calif.-based company said it inked a distribution partnership deal in Australia and New Zealand with medical product supplier Device Consulting, which will support the regional distribution of the Viveve […]