FDA warns J&J, Sientra over lack of post-approval silicone gel breast implant studies


The FDA today released warning letters it sent to Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide and Sientra (NSDQ:SIEN) over failures to conduct appropriate post-approval studies to analyze the long-term safety and risks associated with their silicone gel-filled breast implants.

The federal watchdog said that every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies of the devices to maintain appropriate data on the long-term safety and potential risks associated with the devices that premarket trials cannot foresee.

In its letter to J&J’s Mentor, the FDA noted a failure to enroll the appropriate amount of patients in the post-market study of its MemoryShape breast implant which won approval in 2013. The federal watchdog also said that Mentor had poor follow-up rates with patients and noted significant data inconsistencies in the report, including poor patient accounting and missing race and ethnicity data.

In its letter to Sientra, the federal watchdog knocked the company on its 61% follow-up rate, which falls below the target for the post-market study.

The agency said that both companies’ failure to address the raised concerns and comply with the post-approval study requirements violates its pre-market approval order. The FDA gave both companies 15 days to comply with the warnings.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations. We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients,” FDA Commissioner Dr. Scott Gottlieb said in a prepared statement.

Last month, the FDA said that it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths.

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FDA ramps up scrutiny of materials in medical devices

(Image by Michael Longmire on Unsplash)

The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.

It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series ripped the agency and the industry over patient injuries attributed to faulty devices. The FDA has been particularly faulted for its 510(k) clearance pathway, under which it allows devices that are similar to previously approved technology to undergo a less strenuous review before they can be sold.

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

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Sientra plunges on Q4 earnings miss, clouded outlook

SientraA fourth-quarter earnings miss and the uncertainty around an upcoming FDA advisory panel meeting on breast implants sent Sientra (NSDQ:SIEN) shares down precipitously today.

The Santa Barbara, Calif.-based medical aesthetics company’s losses widened 38.1% to -$24.6 million, or 86¢ per share, on sales growth of 71.9% to $19.0 million for the three months ended Dec. 31, 2018, compared with Q4 2017. Analysts on Wall Street were looking for losses of -68¢.

Full-year losses were up 29.0% to -$82.6 million, or -$3.25 per share, on sales growth of 86.4% to $68.1 million compared with the prior year, Sientra said. Breast implant sales are expected to grow by at least 25% to $26 million this year, chairman & CEO Jeff Nugent said, taking into account softness during the first and second quarters around the risk that the March 25 meeting of the FDA’s General & Plastic Surgery Devices advisory panel will recommend restrictions on textured breast implants.

Although the FDA’s warning about the risk of a form of lymphoma associated with textured implants goes back at least two years, recent developments have pushed the issue into the spotlight. For years the safety watchdog’s “summary reporting” policy allowed medical device manufacturers to lump hundreds of adverse event reports into a single filing, meaning that the reported rate of bad outcomes – including deaths – was kept artificially low. From 2008 to 2015 there were only 200 reports stemming from breast implants.

But in 2017 the FDA began requiring companies to report each adverse event on its own. As a result, the agency received more than 4,000 breast implant injury reports in the second half of that year and another 8,000 during the first half of 2018.

Then, last December, Allergan yanked its textured breast implants from the European market after French regulators declined to renew its CE Mark approval until the company submitted more data on the lymphoma risk. And in February the FDA revealed 457 reports of unique cancer cases related to breast implants since 2010, including nine deaths, and announced its plans to convene the plastic surgery panel to consider breast implants.

Nugent said he expects the meeting to help settle investors’ nerves.

“Look, we’re very familiar with the history associated with breast implants. Using history as our guide, we believe that there will be a responsible action taken by the FDA that, at the end of the day, will reduce the uncertainty about the risk associated, that we believe will pick up procedures in the back half of the year,” he told analysts during a conference call yesterday. “There’s a significant amount of uncertainty associated with the risks that we are expecting to be clarified, mitigated to a significant extent in the back half.”

Still, the soft forecast and the earnings miss combined to push SIEN shares down -24.% to $8.55 apiece today in early-afternoon trading.

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BD’s Bard pulls all pelvic mesh products from EU market

Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard is removing its women’s pelvic organ prolapse and stress urinary incontinence mesh devices from the European Market, according to a recently posted field corrective action from the company.

The Murray Hill, N.J.-based company said that it is “initiating a cease in production and distribution of these devices and a removal of these products from hospitals and distribution centers with immediate effect,” according to the notice.

The removal of the devices was not a result of safety concerns, Bard clarified, adding that patients with such devices do not require any follow-up activities.

In the letter, Bard instructed individuals with affected devices to locate and quarantine them and to notify anyone who the products have been distributed to so that the devices could be appropriately returned.

The company again reiterated that implanted devices are not affected by the recall, and that no additional activities are required for patients with the meshes.

In January, Bard and subsidiary Davol won an appeal in a lawsuit involving a woman who died a year after having a Bard surgical mesh patch implanted to repair a hernia.

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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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FDA warns against robot-assisted breast cancer surgeries

FDA-logo-newFDA has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer.

The safety and effectiveness of surgical robots have not been established for use in mastectomies or for surgeries to prevent or treat breast and other cancers, according to the agency, which said it “encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use.”

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

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Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products


Longer, more extensive studies and a focus on subjective quality of life outcomes were among the top agreed upon recommendations for future trials studying transvaginal mesh implants used for treating pelvic organ prolapse, according to a MedTech Dive report covering the recently held FDA transvaginal mesh advisory panel.

While the panelists didn’t vote on any specific questions, they did stand behind vaginal mesh products being offered as an option to women with pelvic organ prolapse, with a particular focus on women who are not good candidates for native tissue repair, according to the report.

The group agreed that improvements were needed, both in depth and length, for both premarket and postmarket studies of the devices, MedTech Dive reports. Premarket approval studies should follow patients out to at least 18 to 24 months, while postmarket studies should follow patients to five years, the panel agreed.

Trial endpoints should compare superiority to native tissue repair at 12, 24 and 36 months as compared to the general population, while non-inferiority would be required as compared to outcomes in women who have failed native tissue repairs, according to the report.

A focus on subjective quality of life scores should also garner more attention, as pelvic organ prolapse is a non-life threatening condition, the panel agreed. In addition, women should be informed that the implants are not expected to be durable beyond 10 years, MedTech Dive reports.

Each consensus was not unanimous, according to the report, with dissenting voices concerned over the viability of extensive long-term studies and confounds including skill gaps between research surgeons and the general population.

Criticism of the FDA’s Media Device Reports system were also brought to light by former FDA UDI external program manager Madris Tomes, who now runs adverse event analysis company Device Events, MedTech Dives reports.

In a presentation, Tomes identified features of the FDA’s Manufacturer and User Facility Device Experience database that allow manufacturers to disassociate harm from device problems and submit summary reports that can include a number of patient complaints but only count as a single adverse event case, according to the report.

Experts and patient advocates were also critical as to whether companies’ postmarket 522 studies, which in nature fall short of data generated from gold-standard randomized, blinded studies, could provide appropriate data to support clearance of transvaginal mesh devices, according to Medtech Dive.

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Study: Use of long-acting reversible contraception spiked after 2016 election

In a study published this week in JAMA Internal Medicine, researchers reported that use of long-acting reversible contraception increased in the month following the 2016 presidential election.

Adjusting for seasonal trends and patient characteristics, the researchers from Brigham & Women’s Hospital found that insertion of contraceptives such as intrauterine devices increased by 21.6% after the election of President Donald Trump.

Get the full story at our sister site, Drug Delivery Business News.

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Philly jury hits J&J’s Ethicon with $41m judgment in pelvic mesh case

gavel, legal

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has been hit with a $41 million verdict in a pelvic mesh product liability suit in Philadelphia, according to a report from the Mesh News Desk.

A jury in Philadelphia found that Ethicon’s Gynemesh, Prolift and TVT-O meshes were defective, and that the company was negligent in manufacturing the devices, according to the report.

The plaintiff, Suzanne Emmett, was implanted with a Prolift pelvic mesh to treat pelvic organ prolapse, a TVT-O mesh as a treatment for incontinence and a Gynemesh implant, according to the Mesh News Desk report.

The verdict includes $25 million in punitive damages, $15 million in compensation and $1 million to Emmett’s husband, according to the report.

The company has not yet commented officially on the case, and has not stated if it plans to appeal the decision.

Last November, a state judge in Pennsylvania ordered a new trial in a suit alleging a that a woman was injured by Ethicon’s TVT-Secur pelvic mesh implant.

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MobileODT touts colposcope-based cervical cancer detection AI


MobileODT said last week that it is implementing a new artificial intelligence algorithm in its EVA system Colposcope that it claims can detect cervical cancer more effectively than existing testing.

The new technology, known as Automated Visual Evaluation, has been validated by the National Cancer Institute and the National Library of Medicine, the Israel-based company said, and is able to identify problematic lesions with greater reliability than traditional Pap Cytology testing.

MobileODT said that it is working with the NCI and other researchers to continue validating the AVE algorithm, and that it is launching a large scale pilot looking to validate the clinical application of the AVE algorithm with partners at India’s Genworks Health and Apollo Hospitals.

In the study, researchers will investigate the use of the AI algorithm in detecting cervical cancer in up to 250 women, the company said. It is hopeful that data from the trial will help improve the effectiveness of the AVE tech.

“We are excited by the new AVE algorithm and the promise it holds in fighting cervical cancer. Our team is proud to make available an AVE enabled colposcope to reach more women and save more lives,” CEO Ariel Beery said in a press release.

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