Wednesday, 18 September, 2019

FDA Halts Sale of All Pelvic Mesh Products

FDA halts sales of vaginal mesh unconvinced it’s safe or effective U.S. halts sales of pelvic mesh tied to injuries in women
Anna Jefferson | 18 April, 2019, 20:41

USA health regulators are halting sales of a sort of surgical mesh used to fix pelvic conditions in girls.

The FDA said it "has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices".

In 2016, the FDA reclassified surgical mesh products intended for transvaginal fix to indicate they were the most high risk of devices the agency evaluated, according to an agency statement.

"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term", FDA's Center for Devices and Radiological Health Director Jeff Shuren said in a news release.

Like most medical devices on the market, the FDA approved pelvic mesh through a regulatory pathway that reviews new products based on their similarities to decades-old devices already on the market, rather than new testing in patients. The finding may complicate the outcome of lawsuits against the companies, which have continued to sell the mesh even as women claimed they caused permanent pain and damage.

Surgical mesh has been used by surgeons since the 1950s to fix abdominal hernias. Boston Scientific said it is "deeply disappointed" in a statement to MedTech Dive and believes "the inaccessibility of these products will severely limit treatment options" for women with pelvic organ prolapse (POP).

About 1 in 8 women have surgery to fix the condition, and a subset of the procedures use the mesh, the agency said. In the 1990s, gynecologists began implanting surgical mesh for the transvaginal fix of the condition and in 2002, the first mesh device specifically for this objective was cleared for use by the FDA, according to the agency's statement. It is the most stringent action the F.D.A. has taken in the lengthy legal and medical battles over vaginal mesh, a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area.

Bahrain sentences 138 individuals on terror charges
The defendants, of which 109 are in custody and 60 were tried in absentia, are allowed to appeal the sentences. Some members had received military training in Lebanon, Iran and Iraq, he claimed in the statement.

'Halo' TV Series Cast Recruits Pablo Schreiber to Play Master Chief
Schreiber was nominated for an Emmy for his work in Orange is the New Black and also had roles in American Gods and The Brink . According to Hollywood Reporter , the pick was the result of a worldwide casting search that also brought in some newcomers.

Facebook "Unintentionally Uploaded" Email IDs Of 1.5 Million Users
Facebook then imported users' contacts without first asking permission, Business Insider reported . Facebook changed the verification process in 2016 and that's when the mistake happened.

Uphold LITE Vaginal Support System with Capio SLIM (Medical Device licence: 98223) from Boston Scientific. The surgical meshes were the topic of a "60 Minutes" investigation in 2018.

Patient advocates and consumer watchdog groups applaud the FDA's crackdown on mesh. However, the percentage of women undergoing transvaginal POP mesh procedures has decreased in recent years after the FDA began issuing warnings about the risks associated with using transvaginal mesh used for POP fix.

She calls on the FDA and medical device industry to "do the right thing" and stop making and marketing pelvic mesh.

Surgical mesh continues to be available for cases of stress urinary incontinence, hernias and breast reconstruction.

Zuckerman says the agency should require clinical trials for all mesh used in surgeries. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex.

In the meantime, the FDA has told women who are now implanted with mesh to continue to see their doctors for routine check-ups.

The agency said the women who have had transvaginal mesh used for their condition don't need to take any action if they are satisfied with their surgeries and don't have any symptoms.

Recommended

  • Kia Habaniro concept unveiled

    Kia Habaniro concept unveiled

    Design is what the Habaniro is about, the Kia has even invented a new designation for this body style: the Everything Car. Michael Cole, Kia's COO and executive vice president, called the HabaNiro "a genius work of skill and imagination".
    Nintendo Advert Leaks Stage Builder For Super Smash Bros. Ultimate

    Nintendo Advert Leaks Stage Builder For Super Smash Bros. Ultimate

    Ultimate and the Nintendo Switch may have unintentionally unveiled that stage builder is coming to the latest Smash Bros . game. Assuming this teaser holds up, Ultimate will be the third Smash game to get a stage builder .
    Nintendo Switch, New Models Coming? Update 8.0.0 Suggests It

    Nintendo Switch, New Models Coming? Update 8.0.0 Suggests It

    The update should roll out automatically to Switch owners, though it can be downloaded manually otherwise. The Nintendo Switch received the 8.0.0 update which introduces one of the most desired functionalities.
  • Zuckerberg leveraged Facebook data to help friends

    Zuckerberg leveraged Facebook data to help friends

    Facebook shouldn't charge developers for access to basic data feeds, Zuckerberg wrote to software engineers in 2012. In some occasions, Facebook would recompense chosen companies by providing them outflow to the data of its users.
    UK inflation holds steady in March amid Brexit uncertainty

    UK inflation holds steady in March amid Brexit uncertainty

    The March reading easily outshone analysts' consensus forecast for an increase of just 0.3 percent, according to a Bloomberg poll. Sterling inched up 0.1 percent to $1.3066 by 0800 GMT, while against a stronger euro it fell 0.3 percent to 86.735 pence.
    Kraken Follows Binance, to Delist Bitcoin SV

    Kraken Follows Binance, to Delist Bitcoin SV

    Is BSV "headed for zero"? Earlier, two other tokens were delisted by Kraken. "$BSV bag holders prepare for incoming tears". As such, an online campaign against Bitcoin SV , dubbed #delistBSV , has been gathering steam during the last week.
  • Wet weekend ahead for Easter, Passover

    Wet weekend ahead for Easter, Passover

    More showers are expected on Easter Sunday , though the weather service forecast says "it does not look to be a complete washout". Mr Deakin concluded: "Into the weekend, the fine weather will persist throughout Friday , into Saturday and for most on Sunday ".
    Powerful 6.1 magnitude quake  hits Taiwan, shaking buildings in the capital

    Powerful 6.1 magnitude quake hits Taiwan, shaking buildings in the capital

    A building on Chang An East Road was found to have tilted, leading to the evacuation of more than 30 people to a nearby park. The quake, which was the most severe in the region in 67 years, was followed by more than 60 aftershocks within eight hours.
    HBO Releases 'Game of Thrones' Season 8, Episode 2 Photos

    HBO Releases 'Game of Thrones' Season 8, Episode 2 Photos

    Data from piracy monitoring firm MUSO indicates the show was pirated 54 million times in the first 24 hours. They found out that the most pirated views came from India with roughly 10 million views.
  • British diver who helped rescue Thai cave boys gets trapped in cave

    British diver who helped rescue Thai cave boys gets trapped in cave

    After emerging from the cave after his 28-hour ordeal, Bratchley declined medical care-but asked for pizza. Josh Bratchley, a cave diver from the United Kingdom , was among the personnel who helped them escape.
    ROOMZZ Concept Unveiled In China

    ROOMZZ Concept Unveiled In China

    Various seating configurations can be adapted not only to passengers' personal wishes, but also to the respective driving mode. Roomzz with a 82-kWh battery for "a range of up to 450 km (WLTP) or 475 km (NEDC, China)", according to Electrek.
    Ivanka Trump says she passed on World Bank job

    Ivanka Trump says she passed on World Bank job

    Trump had also suggested that he'd considered offering her a role as United Nations ambassador as a replacement to Nikki Haley. Asked if her father had approached her about other top jobs, Ivanka Trump said she'd "keep that between" them.

Congress Subpoenas Deutsche Bank As Part Of Democrats' Probe Of Trump Finances Congress Subpoenas Deutsche Bank As Part Of Democrats' Probe Of Trump Finances The Trump Organization is believed to have about $300m in loans still outstanding . The full scope of the subpoenas to Deutsche Bank could not be determined.

Jason Momoa shaves off his famous beard leaving fans 'distraught' Jason Momoa shaves off his famous beard leaving fans 'distraught' Infinitely recyclable . " Aquaman's just trying to do the best he can for my kids, for your kids, for the world." . But Jason Momoa , 39, has left some of his loyal fanbase distraught by shaving off his long beard.

T2 Trainspotting Actor Bradley Welsh Shot and Killed Near His Home T2 Trainspotting Actor Bradley Welsh Shot and Killed Near His Home He was reportedly shot in the head following a confrontation in Edinburgh, according to the The Sun . He previously appeared on the documentary series Danny Dyer's Deadliest Men in 2008.

The First Image of a Black Hole Is Here The First Image of a Black Hole Is Here But seeing is believing, noted Dan Marrone, an astrophysicist at the University of Arizona who sits on the EHT's science council. Confirming the predictions of general relativity, and seeing the event horizon, is magical.

Trump advise Boeing to rebrand 737 MAX Trump advise Boeing to rebrand 737 MAX American Airlines has cancelled all of its Boeing 737 Max flights until the middle of august. It's unclear when the 737 Max will be able to resume service.

Baby Sussex watch: Fans spot intense movement in Meghan Markle's bump Baby Sussex watch: Fans spot intense movement in Meghan Markle's bump Whether a $5 donation, £1000 contribution, offering to volunteer, or spreading the word - you've played your part. Follow Yahoo Lifestyle on Facebook , Twitter and Instagram . "She was under no pressure to do things the same".

North Korea Demands Pompeo's Removal From Nuclear Talks With US North Korea Demands Pompeo's Removal From Nuclear Talks With US KCNA didn't describe the weapon exactly but said it has a "peculiar mode of guiding flight" and "a powerful warhead". Analysts in South Korea said North Korea was trying to send a message to the USA and South Korea.

Cameron Norrie reaches Monte Carlo quarters - Monte Carlo Masters 2019 Cameron Norrie reaches Monte Carlo quarters - Monte Carlo Masters 2019 I had some good practice after Miami and I am doing well, I am just practising to be ready for my first match here. Zverev, who made the semifinals of Monte Carlo a year ago , broke the Canadian teen six times en route to the win.

Canada’s Denis Shapovalov falls in first round of Monte Carlo Masters Canada’s Denis Shapovalov falls in first round of Monte Carlo Masters The Canadian talent let slide his 7-5 opening set victory before faltering in the following two sets 6-3, 6-1. Cecchinato, a French Open semifinalist past year , was leading 4-0 when Damir Dzumhur pulled out.

Chips Ahoy cookies recalled due to ‘unexpected ingredients’ Chips Ahoy cookies recalled due to ‘unexpected ingredients’ This recall is limited exclusively to the products listed in the table below, available at retail stores nationwide. Mondelez says none of its other products, including other Chips Ahoy products, are included in the recall.

Facebook Announces That it Will End P2P Payments in United Kingdom and France Facebook Announces That it Will End P2P Payments in United Kingdom  and France Navarra shared the image of Facebook notification that has been sent to the users who have used the P2P service in the past. The company has also acquired blockchain startup chainspace in a bid to leverage DLT skills to its staff.

Fire broke out at Al-Aqsa same time as Paris’s cathedral burned Fire broke out at Al-Aqsa same time as Paris’s cathedral burned According to the Palestine News Agency, President Mahmoud Abbas has expressed "deep regret" over the fire at the Notre Dame. The fire broke out at the roof of a structure known as the Al Marwani prayer room in Al Aqsa mosque , GulfNews reported .

A 'pink moon' is coming: What you need to know A 'pink moon' is coming: What you need to know In other words, the moon is completely sunlight and appears to us from the earth as a round white disk. Next month's full moon is also a seasonal blue moon, creating the moniker Blue Flower Moon.

Michelle Obama slammed for comparing Trump to divorced dads Michelle Obama slammed for comparing Trump to divorced dads Michelle Obama has come under fire for comparing President Trump to a divorced dad, over his transgender policies. Michelle Obama is now facing backlash for a comment she made in reference to Donald Trump and his administration.

Swamp Thing Teaser Arrives as DC Series Unexpectedly Shuts Down Swamp Thing Teaser Arrives as DC Series Unexpectedly Shuts Down But in the meantime, Swamp Thing , even with its shortened episode order, will premiere on the service on May 31 . It's always been rumored that the DC Universe streaming service has been struggling to find an audience.