Feds want more input on materials with ‘high-profile safety concerns’

The FDA today asked the public to submit comments on how devices that contain certain materials should be labeled.

The materials are ones to which patients have long-term exposure — contact time exceeding 30 days — and that have presented “high-profile safety concerns,” according to the agency. They include female sterilization devices, metal-on-metal hips and breast implants.

Get the full story on our sister site, Medical Design & Outsourcing.

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The top 5 MassDevice stories of the week — August 21, 2020

COVID-19 continues to dominate medical device industry news on MassDevice.

The pandemic is causing more major lawsuit settling — as well as efforts to offer more medtech to enable better management of the coronavirus.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. CureVac raises more than $200M in IPO

CureVac (NSDQ:CVAC) — a Germany-based biotech outfit — is developing a COVID-19 vaccine with backing from the Bill and Melinda Gates Foundation. Read the full story. 

4. This telemedicine system could get medtech sales reps back to ORs

Avail Medsystem’s telemedicine system could prove a more efficient way for sales reps to sit in on surgeries, especially as the COVID-19 pandemic continues to hinder access to hospitals. Read the full story.

3. FDA clears ClearMask transparent surgical mas…
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BREAKING: Bayer settles 90% of Essure claims for $1.6B

Bayer (ETR:BAYN) announced today that settled approximately 90% of U.S. claims involving women alleging injuries related to its Essure device.

Leverkusen, Germany-based Bayer reached agreements with plaintiff law firms on about 90% of the nearly 39,000 filed and unfiled U.S. Essure claims from women who allege device-related injuries, according to a news release. Settlements include all jurisdictions with significant volumes of Essure cases, and the company will pay approximately $1.6 billion to resolve the claims.

Settling claimants will be required to dismiss their cases or not file, according to the company, and there is no admission of wrongdoing or liability by Bayer in the agreements. The other terms of the settlements are confidential and the settlement amount is covered by existing provisions. The U.S. settlements have no impact on pending litigation in other countries.

Bayer said virtually all its U.S. Essure litigation is now resolved, adding t…

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Bayer sets aside nearly $1.4B for potential Essure settlements

Bayer (ETR:BAYN) during its second quarter ended June 30 set aside €1.245 billion ($1.39 billion), mainly to provide for potential lawsuit settlements related to its Essure permanent birth control device.

Some of the provision was also for litigation defense costs and other pharmaceutical matters.

As of July 24, Bayer faced U.S. lawsuits from roughly 32,000 Essure users claiming device-related injuries including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, according to the company.

Settlement discussions have recently intensified, and the company said during its Q2 results announcement today that it has seen progress in recent weeks.

Marketed as a permanent birth control device, Essure has not been available for implantation in the U.S. since December 2019, having had U.S. sales for the device discontinued in December 2018.

Recently released interim results of an Essure postm…

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Bayer failed to report Essure problems, lawsuit claims

Bayer (ETR:BAYN) failed to tell FDA about thousands of injury complaints related to its Essure contraceptive device, according to newly unsealed lawsuit documents reported by Bloomberg.

The lawsuit documents out of California claim that the underreporting went back before Bayer acquired Essure maker Conceptus for $1.1 billion in 2013. Bayer responded to Bloomberg last week that it continues to “stand behind Essure’s safety and efficacy” — with 270,000 women involved in Essure research over the past two decades.

FDA announced in 2018 that U.S. sales of the Bayer permanent birth control device would discontinue amid complaints from women about unexpected pregnancies and injuries following implantation. Essure has no longer been available for implantation in the U.S. since December 2019.

The Bloomberg report on July 10 came on the heels of FDA posting interim results of an Essure postmarket study that found higher rates of chronic lower abdominal and/…

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Essure study shows more pain, bleeding in women with implant

Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control.

The FDA posted the results as part of a long-term safety evaluation of the device, which has been the subject of thousands of lawsuits worldwide. Essure has not been available for implantation in the U.S. since December 2019, having had U.S. sales for the device discontinued in December 2018.

Essure patients also reported higher rates of gynecologic surgical procedures, including surgery to remove Essure, than patients who had tubal ligation, according to Dr. Terri Cornelison, the director of the FDA Health of Women Program in the Center for Devices and Radiological Health. Pregnancy rates are similar for patients with Essure or tubal ligation.

In February 2016, the FDA ordered Bayer to co…

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