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

March 19, 2019 By Fink Densford Leave a Comment

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.

New 510(k) boosts iRhythm, Verily efforts for AFib screening
The latest 510(k) clearance for the Verily Study Watch will further the efforts of the Google sister company and iRhythm Technologies (NSDQ:IRTC) to improve atrial fibrillation treatment. Verily — a life science company under Alphabet (NSDQ:GOOGL) — recently received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. “We’ve worked carefully to meet the FDA’s stringent… […]
Argon Medical debuts IVC filter retrieval kits
Argon Medical Devices (Frisco, Texas) said this week that it has launched single-loop and triple-loop retrieval kits for percutaneous removal of inferior vena cava (IVC) filters that are no longer medically required. The kits are indicated for use via a jugular approach and offer the following features: A coil-reinforced outer sheath with the strength needed… […]
NANS 2020: Neuromodulation news you need to know
Neuromodulation devices from companies including Medtronic (NYSE:MDT), Abbott (NYSE:ABT) and SPR Therapeutics are showing promise treating pain. That’s one of the initial takeaways from study results that medical device companies in the neuromodulation space are touting this weekend at NANS 2020 in Las Vegas. NANS is a joint conference of Congress of Neurological Surgeons and the North American Neuromodulation… […]
Injection Molding Principles
Optimizing custom part designs for injection molding requires a thorough understanding of the process and outcomes. In this e-book, you’ll learn about common molding resins, special molding terms you should know, and most importantly, how to optimize your part with undercuts, even walls, drafts, and more. Download this e-book from Xometry to learn more… The […]
GW Plastics expands Vermont manufacturing and tech center
GW Plastics announced that it has completed a $10 million expansion of its Royalton, Vt., manufacturing and technology center. The company said it has added a 30,000 ft2 to the building to accommodate the growth of its thermoplastic injection molding and medical device contract assembly business. The expansion includes a new 13,000 ft2, Class 8… […]
Certain GE Healthcare patient-monitoring devices vulnerable to cyberattack
The federal government and GE Healthcare (NYSE:GE) announced today that the certain of the company’s patient monitoring devices are vulnerable to cyberattack. If attacked, some versions of the Carescape and ApexPro telemetry servers, the Carescape Central Station version 1 and Central Information Center systems could stop monitoring patients, silence alarms or produce unnecessary alarms during… […]
Cardinal Health recalls 9 million surgical gowns, sends hospitals scrambling
Cardinal Health (NYSE:CAH) announced that it is voluntarily recalling 9.1 million surgical gowns produced by an unnamed contract manufacturer after discovering quality issues with the product. The Dublin, Ohio-based company said that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law. Some of the gowns were also… […]
KNF launches compact swing piston pump
KNF Neuberger is touting its NPK 06 swing piston micro gas pumps, designed to deliver high-flow and high-pressure performance in a compact size. The new pumps work well for medical diagnostics, therapy, monitoring, and general compression applications, according to the Trenton, N.J.-based company. NPK 06 measures 1.85” (47mm) wide and can produce free flow up… […]
Heraeus Medical Components and Myant partner on electrical sensing for textiles
Heraeus Medical Components (St. Paul, Minn.) and Toronto-based Myant have entered a partnership enabling Myant to use Heraeus’ Tectitoat for electrical sensing applications in textiles, the companies announced today. Tecticoat is a conductive polymer-based coating that can be applied to textiles to control electrical conductivity, electromagnetic shielding and electrostatic dissipation, making it suitable for integration… […]
Cook Medical’s peripheral artery set debuts in U.S.
Cook Medical recently announced the U.S. launch of its TriForce peripheral crossing set to support vascular obstruction procedures. The TriForce set is designed to be percutaneously introduced into blood vessels to support a wire guide while performing a peripheral intervention, according to the Bloomington, Ind.-based company. This device is also intended for injection of radiopaque… […]
Bayer and Exscientia partner to bring AI to drug discovery
Bayer (ETR:BAYN) announced that it is entering into a collaboration agreement with artificial intelligence drug discovery company Exscientia to identify and optimize novel lead structures for potential drug candidates in treating cardiovascular and oncological diseases. The agreement, announced earlier this month, is slated to see the companies work together on early research projects combining Exscientia’s proprietary… […]