Bayer loses bid to toss some claims in Essure class action suit

A federal judge in Philadelphia will allow six women who are suing Bayer (ETR:BAYN) over its Essure sterilization implant to proceed with their personal injury claims and three others to pursue their breach-of-warranty claims. One woman who became pregnant following implantation with Essure will be able to pursue her claim that Bayer fraudulently concealed the risk of pregnancy, the judge ruled.

Bayer had filed a motion for partial summary judgment on all 12 plaintiffs’ claims in the class action suit, citing statutes of limitations. Judge John Padova of the Eastern District of Pennsylvania granted Bayer’s motion for summary judgment on the personal injury claims of six of the women and on some or all of the breach-of-warranty claims of nine women.

The women had the Essure coils implanted in their fallopian tubes between 2006 and 2013 and claimed they suffered a variety of ailments afterward, including pain, bleeding and autoimmune disorders. Two became pregnant.

Under Pennsylvania law, the women had two years to file claims seeking damages for personal injury and four years to file claims for breach of warranty. Bayer and some of the women differed on when the clock began to run, based on when the women — or their doctors — connected their health problems to Essure and when they filed suit.

Padova heard the arguments on Bayer’s motion on February 11. Bayer took Essure off the market in the United States in December 2018. In April of 2018, the FDA put restrictions on U.S. sales of Essure, a small metal coil that’s placed in the fallopian tubes via catheter, after concluding that some patients were not adequately warned of its risks.

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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 fibroids under intrauterine ultrasound guidance. The mean follow-up period for the patients enrolled was 5.4 years.

Highlights from the study include:

  • No surgical reinterventions in the first 3.4 years.
  • Annualized surgical reintervention rate per year of 2.2%.
  • 11.8% cumulative reintervention rate through 5.4 years average follow-up.
  • 37 point mean improvement in symptom severity score at follow-up.
  • 49 point mean improvement in health-related quality of life at follow-up.

“We have evaluated many new fibroid treatment innovations in our facility and are especially impressed with the patient results achieved with Sonata over this extended time frame,” said Jose Gerardo Garza-Leal, M.D., of the Universidad Autonoma de Nuevo Leon in Monterrey in a prepared statement from Gynesonics. “Such lasting results are even more impressive considering the low risk and quick recovery our patients experienced with the Sonata procedure, especially when compared to other fibroid treatment alternatives.”

Redwood City, Calif.-based Gynesonics said its Sonata system platform provides transcervical access to a wide range of fibroid types, most of which cannot be treated with current operative hysteroscopy methods.

In January, the company released 12-month results from an FDA investigational device exemption pivotal trial of Sonata at 21 outpatient sites in the U.S. and a single site in Mexico. Data from the trial indicated that 99% of patients required no surgical reinterventions for heavy menstrual bleeding, with 97% reporting satisfaction with the treatment. Symptom improvement was reported by 96% of patients, with 95% reporting a reduction in menstrual bleeding. A total of 65% of the trial’s 147 patients reported at least a 50% reduction in menstrual bleeding.

The National Institutes of Health estimate 200,000 hysterectomies are performed in the U.S. each year specifically to address symptomatic uterine fibroids. With an estimated volume of more than 1 million annual global uterine fibroid procedures, Gynesonics projects a $3 billion-$4 billion global market opportunity for its Sonata system, including a market opportunity of more than $1 billion in the U.S. alone.

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How AI can detect cervical cancer

Cervical cancer cells (Image from National Cancer InstituteWinship Cancer Institute of Emory University)

Researchers have developed a computer algorithm that they say can analyze digital images of a woman’s cervix and accurately identify precancerous changes that require medical attention. This artificial intelligence approach, called automated visual evaluation, has the potential to revolutionize cervical cancer screening, particularly in low-resource settings.

Led by investigators from the National Institutes of Health and humanitarian tech investment fund Global Good, the researchers used comprehensive datasets to “train” a machine-learning algorithm to recognize patterns in complex visual inputs, such as medical images. The findings were confirmed independently by experts at the National Library of Medicine. The results appeared in the Journal of the National Cancer Institute (NCI).

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

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Clinical Innovations purchases Australian distributor JB Medical Supplies

Labor, delivery and neonatal intensive care devices company Clinical Innovations (Salt Lake City) has acquired Australian distributor JB Medical Supplies.

The deal, announced yesterday, is meant to bolster Clinical Innovations’ position in Australia. JB Medical Supplies will operate as a wholly owned subsidiary of Clinical Innovations.

Financial terms of the deal were not disclosed.

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

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Power morcellation: Questions linger for controversial tech

Dr. Amy Reed’s tragic case brought to light the cancer risks posed by power morcellation. Her death hasn’t stopped lingering questions about the technology.

Power morcellators were used for 20 years to laparoscopically remove fibroids, benign tumors of the uterus, raising not a single adverse event report with the FDA. That all changed in 2013, when Dr. Amy Reed, an attending physician at Beth Israel Deaconess Medical Center, underwent a myomectomy using power morcellation at nearby Brigham & Women’s Hospital.

Reed’s fibroids were not benign, but instead a malignant form of cancer called uterine sarcoma that’s difficult to distinguish from benign tumors. Days after her procedure, Reed’s formerly treatable condition had been upstaged to a deadly cancer.

It turned out that power morcellation, a laparoscopic procedure in which surgeons use the device to mince the tumors, can seed malignant cells throughout the abdomen, drastically accelerating the cancer’s advance. Reed died last year at 44 of complications from her 2013 myomectomy, but not before she and her husband, Dr. Hooman Noorchasm, mounted a successful public health campaign to raise awareness of the risks posed by power morcellation. In 2014 the federal safety watchdog issued a black box warning for power morcellators, prompting Johnson & Johnson to pull its power morcellator from the market.

With the devices gone, a void emerged in the market – women who would have undergone a laparoscopic procedure with a morcellator now faced an open uterine resection. Organizations including the American College of Obstetricians & Gynecologists teamed with the Agency for Healthcare Research & Quality to lobby for the FDA to reconsider its 2014 guidance, arguing that patients need a laparoscopic option for tissue removal.

Meanwhile, some medtech entrepreneurs saw the risks posed by morcellators as an opportunity to create a device that would address the morcellator’s shortcomings. Eximis Surgical, a tiny Colorado-based company, set out to do just that.

Eximis came across Noorchasm’s radar after announcing that it raised $5 million from 33 investors to fund the development of its laparoscopic tissue removal system. He noticed that on their LinkedIn account, Eximis named Reed as the inspiration behind their technology. Noorchasm penned a letter to Eximis executives and published it online, asking them to remove any reference to Reed and, among other things, acknowledge that their technology is simply a resurrected version of a power morcellator.

“What they’re marketing is something that goes directly in opposition to what Amy and myself have been speaking out against,” he told Medical Design & Outsourcing. “It doesn’t matter what words you use, it doesn’t matter if you say morcellate, slice up, dice up, XCor out – if you take a tumor that has malignant potential and you mince it up, you’re exposing that patient to the risk of their cancer being upstaged.”

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

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British health watchdog recommends vaginal mesh ban


Pelvic meshA British health watchdog reportedly plans to recommend that the National Health Service there ban vaginal mesh implants to treat pelvic organ prolapse, citing “serious but well-recognized safety concerns.”

In recommending that the implants be limited to research use only, the U.K.’s National Institute for Health & Care Excellence said “evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity,” according to the BBC.

Randomized, controlled trials “showed no added benefit of using mesh compared with native tissue repair,” according to the NICE report. “[W]hen complications occur, these can be serious and have life-changing consequences.”

More than 92,000 women had vaginal mesh implants in England between April 2007 and March 2015, the BBC reported, citing NHS data. About one in 11 women experienced problems with the implants, according to the data.

The proposed ban does not mention the use of pelvic mesh to treat female urinary incontinence, the British news service said.

In the U.S., tens of thousands of product liability lawsuits have been filed against medical device companies over their respective pelvic mesh offerings.

Last month a federal appeals court upheld a plaintiff’s $27 million win over Boston Scientific (NYSE:BSX) in a product liability lawsuit brought over its Pinnacle pelvic mesh, a month after Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon was hit with a $57.1 million verdict in a pelvic mesh case out of Pennsylvania.

Teva closes Plan B emergency contraception sale in $2.3B restructuring effort

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  • Teva closes Paragard sale to CooperSurgical


    The Cooper Co.'s, Teva PharmaceuticalsTeva Pharmaceuticals (NYSE:TEVA) said today that it closed the $1.1 billion cash sale of its Paragard intrauterine copper contraceptive device to Cooper Cos.‘ (NYSE:COO) CooperSurgical unit.

    The deal included Teva’s manufacturing facility in Buffalo, N.Y., the pharma company reported.

    The move is part of Teva’s efforts to restructure its business, narrowing its focus on CNS and respiratory conditions. The company also plans to divest of its oncology and pain businesses in Europe. In September, Teva inked deals to sell off the rest of its women’s health biz.

    “With completion of the sale of Paragard, Teva demonstrates strong execution of our strategic divestiture plan,” Teva’s out-going president & CEO Yitzhak Peterburg said in prepared remarks. “We now have an infusion of $1.1 billion to progress the repayment of term loan debt and are on track to deliver on our promise to generate net proceeds of at least $2 billion from the divestiture of non-core assets. We are very pleased to have completed this sale to CooperSurgical which will help to not only allow for greater focus within Teva’s global specialty medicines business but also assure that patients in the U.S. continue to benefit from access to this important contraceptive product.”