Gynaecology/Obstetrics

Last week we covered the latest news from the J&J transvaginal mesh proceedings. At the time, the jury had awarded … continue reading “J&J Will Appeal New $11M Pelvic Mesh Award”

J&J should pay a South Dakota nurse $3.35 million according to the jury in the much-reported vaginal mesh trial. They found that the company had failed to provide adequate warning of risks to the plaintiff’s doctor. J&J’s rebuttal to follow.

The Lawsuit Settlement Funding Company, which has been a public advocate for women victims of various vaginal and pelvic mesh implants, reported today that industry insiders close to the Ethicon Prolift mesh trial have advised them that the plaintiff’s case has raised serious concerns as to what J&J knew about the dangers of their mesh products.

Ethicon Endo-Surgery says its ENSEAL® advanced bipolar devices are strong on sealing, yet gentle on tissue. And now with a new Articulating iteration these benefits can be exploited in the most difficult-to-access anatomies.

UK technology company Zilico tells us that its Zedscan electrical impedance probe can improve colposcopic outcomes, while reducing the need for biopsies. A new paper supports that view with improvements in detection and specificity compared with colposcopy alone.

The C SAFE caesarean section safety device from Brolex has emerged pretty well from a piece in “Reviews in Obstetrics & Gynecology.” C SAFE received the highest number of perfect “5” scores in the history of “MedReviews – OB Product Reviews.”

Vaginal Tape and Mesh problems continue to exist. UK competent authority the MHRA has issued a new document which endeavours to capture the state of play and provide guidance for surgeons in the NHS.

Halt Medical, Inc. announced today at the opening session of the AAGL Global Congress on Minimally Invasive Gynecology that the FDA has cleared Acessa™, a revolutionary new medical technology for treating millions of women suffering from uterine fibroids.

Endometrial preparation does not seem to impact on success of EmbryoGlue, from Swedish fertility company Vitrolife, as study presented at ESHRE conference shows significant pregnancy rate improvement in all cases.

Symmetry Medical Inc. launches a new product designed to mechanically compress the myometrium during postpartum uterine atony after routine caesarian section.

Smith & Nephew has announced the launch of its Truclear 5.0 System, according to the company the smallest hysteroscopic morcellator system to receive FDA 510(k) clearance. The company claims its system’s smaller size now provides surgeons with the potential of using it in the office setting.

Ethicon’s legal representative has written to a federal judge in West Virginia stating it intends to stop selling four vaginal mesh implants after being sued by more than 600 women who say the products caused internal injuries.

Leeds, UK-based Surgical Innovations has renewed its UK distribution arrangement with the signing of a 5 year distribution deal with Elemental Healthcare.

Covidien’s quietly recalling its Roticulators for packaging concerns, but seems to be doing so by stealth rather than adopting the slightly more communicative route one might expect to see.

Consumers union is bent on regulatory tightening and even resorting to print ads in its quest to convince Joe Public that the evil medical device manufacturers are trying to harm him. One wonders whether they have the right objective in mind though because the regulatory regime they might end up with could actually stifle innovation and be more harm to Joe Public than the present set-up.

This new CO2 Laser solution from OmniGuide is claimed to improve surgical precision, access and control.