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  • Regulatory NewsRegulatory News

    FDA affirms increased risk with pelvic mesh products

    The US Food and Drug Administration (FDA) announced on Monday that its review of final results from postmarket surveillance of transvaginal mesh devices meant to treat pelvic organ prolapse (POP) found that patients who received mesh repair had increased risk of mesh exposure and tissue erosion compared to patients whose prolapse was repaired with native tissue.   “Therefore, the FDA continues to believe that these devices do not have a favorable benefit-risk profile,”...
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    Another Class I Recall of Ethicon Surgical Staplers, FDA Says

    Following seven serious injuries and one reported death, the US Food and Drug Administration (FDA) announced a Class I recall, the most serious type of recall, of some of Ethicon’s Flex Endopath surgical staplers because they may contain an out of specification component within the jaw of the device that could lead to malformed staples. Ethicon, a subsidiary of Johnson & Johnson (J&J), said that earlier this month it sent a letter to customers who purchased the affected...
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    FDA Halts All US Sales of Surgical Mesh

    Following thousands of patient lawsuits and a spike in adverse event reports, the US Food and Drug Administration (FDA) on Tuesday ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately. Since FDA reclassified surgical mesh products to class III (high risk) in 2016, the agency said the two manufacturers, Boston Scientific ...
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    Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

    A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding the use of transvaginal mesh implants and advised the agency to consider adverse event reports when conducting premarket reviews. The panel, which was largely compromised of medical doctors, heard from patients who experienced a range of health complications following implantation of the surgical mesh. This marke...
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    Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products (5 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Bans Transvaginal Mesh Products Following Risk-Benefit Review Australia has banned transvaginal mesh products used in the treatment of pelvic organ prolapse. The Therapeutic Goods Administration (TGA) took the action after concluding the risks of the controversial treatment outweigh the benefits. Patients and healthcare experts around the world have questi...
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    Asia Regulatory Roundup: Australia’s TGA to Tighten Regulation of Autologous Cell Products, Ban Ads (31 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA to Tighten Regulation of Autologous Cell Products, Ban Advertisements The Therapeutic Goods Administration (TGA) is planning to tighten oversight of autologous cell and tissue products. TGA’s proposed changes will bring some therapies under the biologicals regulatory framework, ban direct-to-consumer advertising and generally move Australia more in line with the ...
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    FDA Finalizes Two Guidances on Sharing Device Data With Patients, Aspirator Device Labeling

    The US Food and Drug Administration (FDA) on Friday finalized two guidance documents, including one related to medical device manufacturers sharing information with patients upon request, and another to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. Sharing Patient Info The five-page guidance, first released as a draft in June 2016 , is meant to convey FDA's position on manufacturers ...
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    FDA Warns Medtronic Subsidiary Over Adulterated Devices

    Highlighting validation concerns and the distribution of adulterated devices with nonconformities, the US Food and Drug Administration (FDA) earlier this month sent a warning letter to Medtronic subsidiary Tyrx. The letter, dated 2 June, follows an inspection of the company’s Monmouth Junction, NJ-based site from 30 November 2015 through 12 February 2016, with respect to Tyrx’s Antibacterial Envelope, Antibacterial Absorbable Envelope, which is intended to reduce the cha...
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    Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds

    Two safety communications issued by the US Food and Drug Administration (FDA) had different impacts on the use of surgical mesh to treat pelvic organ prolapse (POP), according to a recent study appearing in JAMA Internal Medicine . The first look at the use of surgical mesh in New York between 2008 and 2011 found that use actually increased after FDA's first safety communication, from 21% of all procedures in 2008 to 30% in 2011. However, the use of surgical mesh later ...
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    FDA Increases Regulatory Requirements for Transvaginal Mesh

    The US Food and Drug Administration (FDA) announced Monday that it is increasing regulatory oversight of transvaginal mesh after receiving thousands of reports of injuries, including pelvic pain and bleeding, caused by the devices. Various types of surgical meshes have been in use since the 1950s, and in 1992, FDA cleared the first transvaginal mesh to repair pelvic organ prolapse (POP) as an alternative to native-tissue repair. Under two final orders that take effect T...
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    Liquid-Proof Surgical Gowns? Now FDA Wants Companies to Prove It

    The US Food and Drug Administration (FDA) on Tuesday offered final guidance for companies that will have to conduct performance testing to support claims that their surgical gowns can keep out liquids and submit a 510(k) application within 60 days to the agency to prove those claims. Background In 2000, FDA issued a final rule clarifying the difference between gowns worn by health care personnel and surgical apparel worn by operating room personnel during procedures whe...
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    FDA to Strengthen Definitional Standards for Surgical Gowns Under New Guidance

    It is an iconic image replicated during almost every single infectious disease outbreak in the last century: men and women clad head to toe in surgical gowns and surgical masks, tending to the sick or working to disinfect contaminated areas. But iconic or not, the US Food and Drug Administration (FDA) has a more pressing concern: Are the gowns effective at protecting their users from the spread of infection? Background The question is the focus of a new draft guidance d...