AeroForm Tissue Expander System
The FDA allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities. A patient uses a dose controller to independently inflate the expander. A tissue expander is a balloon-like device that has a soft, expandable polymer shell and is gradually filled with saline or air. Tissue expanders are typically used prior to breast reconstruction to cause breast tissue and muscle to stretch over time, which creates a space (called a “pocket”) for the breast implant. The AeroForm device is a wireless tissue expander for patients who choose to have reconstructive surgery following a mastectomy.
Learn more about the AeroForm tissue expander system
Egalet Corporation announced that the FDA has approved Arymo ER (morphine sulfate) extended-release (ER) tablets C-II for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Arymo ER is developed using Egalet's proprietary Guardian Technology—a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist—creating tablets that are difficult to manipulate for the purpose of misuse and abuse. ARYMO ER has been approved in three dosage strengths: 15mg, 30mg and 60mg.
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The FDA approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. Eucrisa, applied topically twice daily, is a phosphodiesterase 4 inhibitor, although its specific mechanism of action in atopic dermatitis is not known. Eucrisa is manufactured by Anacor Pharmaceuticals, Inc.
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The FDA approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee. Maci is composed of a patient’s own (autologous) cells that are expanded and placed onto a bio-resorbable (can be broken down by the body) porcine-derived collagen membrane that is implanted over the area where the defective or damaged tissue was removed. Administration should be performed by a surgeon specifically trained in the use of Maci.
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The FDA granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.
Learn more about Rubraca
The FDA approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy, a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord.
Learn more about Spinraza
Dexcom’s G5 Mobile Continuous Glucose Monitoring System
The FDA expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes. This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test. The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.
Learn more about Dexcom’s G5 Mobile Continuous Glucose Monitoring System
Roche announced that the FDA has approved Lucentis (ranibizumab injection) 0.5mg for the treatment of patients with myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved anti-vascular endothelial growth factor therapy to treat mCNV in the U.S. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006.
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Roche announced that the FDA has accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy, and are either previously untreated (first-line) or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra.
Learn more about Tecentriq
Centurion Convenience Kits Containing Multi-Med Single Lumen Catheters
Centurion is recalling the Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process. If this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death. The Multi-Med Catheter is used to sample blood, and administer drugs or fluids. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel.
Learn more about Centurion Convenience Kits containing Multi-Med Single Lumen Catheters
Greatbatch Medical’s Standard Offset Cup Impactor
Greatbatch Medical is recalling the Standard Offset Cup Impactor with a POM-C handle that failed sterility testing when sterilized in a dedicated instrument case. Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death. The Standard Offset Cup Impactors are reusable handheld devices used during hip joint replacement surgeries to implant cups in the hip socket (acetabulum). The device is provided as non-sterile and must be sterilized prior to use in surgery. During hip replacement surgery, the ball (femoral head) is removed and replaced with a prosthetic ball, and the acetabulum is removed and replaced with a prosthetic cup.
Learn more about Greatbatch Medical’s Standard Offset Cup Impactor
Nurse Assist Inc.’s Normal Saline Flush IV Syringes
Assist Inc. is recalling the normal saline flush syringes due to incidents
of Burkholderia cepacia contamination. B. cepacia is a bacterium that can cause bloodstream
infections, particularly in patients with weak immune systems. According to the
CDC, the effects of B. cepacia on people "vary
widely, ranging from no symptoms at all to serious respiratory infections,
especially in patients with cystic fibrosis." The use of affected products
may cause serious adverse health consequences including bloodstream bacterial
infections and death. The normal saline flush is a plastic syringe filled
with 0.9% sodium chloride. It
is used to clear out medical devices that deliver medicine directly into the
veins of a patient through a needle or catheter. These syringes are used by healthcare providers in hospitals or
clinics before and after a drip
medication is connected to a patent.
Learn more about Nurse Assist Inc.’s normal saline flush IV syringes
Battery-Powered Mobile Medical Carts
The FDA is warning healthcare facilities of potential safety risks associated with battery-powered mobile medical carts. The FDA is aware of reports of explosion, fires, smoking, or overheating of equipment that required hospital evacuations associated with the batteries in these carts. Battery-powered mobile medical carts are used because of their convenience and utility. The FDA has received medical device reports of hospital fires and other health hazards associated with batteries used in mobile medical carts and their chargers. These events, which range from smoke production and overheating to equipment fires and explosion, can occur with lithium, lead acid, and other types of batteries. Such hazards may result in equipment and facility damage, hospital evacuation, or patient and staff injury.
Learn more about battery-powered mobile medical carts
Chantix and Zyban
Based on FDA review of a large clinical trial that was required by the drug companies to conduct, it has been determined that the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. The risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past. However, most people who had these side effects did not have serious consequences such as hospitalization. The results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines.
Learn more about Chantix and Zyban
Flavored Cigarettes Labeled as Little Cigars or Cigars
The FDA issued warning letters to four tobacco manufacturers—Swisher International Inc., Cheyenne International LLC, Prime Time International Co., and Southern Cross Tobacco Company Inc.—for selling flavored cigarettes that are labeled as little cigars or cigars, which is a violation of the Family Smoking Prevention and Tobacco Control Act. The companies received warning letters for products under the “Swisher Sweets,” Cheyenne,” “Prime Time,” and “Criss-Cross” brands in a variety of youth-appealing flavors, including grape, cherry, wild cherry, and strawberry.
Learn more about flavored cigarettes labeled as little cigars or cigars
General Anesthetic and Sedation Drugs
The FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains. Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. However, further research is needed to fully characterize how early life anesthetic exposure affects children’s brain development.
Learn more about general anesthetic and sedation drugs
Powdered Surgeon Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove
The FDA displayed the final rule to ban powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove because these products present unreasonable and substantial risk to healthcare providers, patients, and other individuals. While medical gloves play a significant role in protecting patients, healthcare providers and other individuals in close proximity, powdered gloves are very dangerous for a variety of reasons. These devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), lung inflammation, and damage or post-surgical bands of fibrous scar tissue that form between internal organs and tissues (adhesions). These adverse events have been attributed to the use of glove powder with all types of gloves. In addition, aerosolized glove powder can carry proteins that may cause respiratory allergic reactions.
Learn more about powdered surgeon gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove
St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter
The FDA is providing information and recommendations regarding St. Jude Medical's radio frequency (RF)-enabled implantable cardiac devices and Merlin@home Transmitter to reduce the risk of patient harm due to cybersecurity vulnerabilities. The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user, i.e., someone other than the patient's physician, to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter. The altered Merlin@home Transmitter could then be used to modify programming commands to the implanted device, which could result in rapid battery depletion and/or administration of inappropriate pacing or shocks.
Learn more about St. Jude Medical’s implantable cardiac devices and Merlin@home Transmitter
InBios International, Inc.’s ZIKV Detect Test
The FDA is alerting physicians who care for pregnant women meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, that the U.S. commercial testing facility, Laboratory Corporation of America (LabCorp), has reported some false positive results from the ZIKV Detect test. Because confirmation tests may take a week to a month to complete, the FDA is issuing this alert so that healthcare providers and patients know about a higher likelihood of false positive results. While the FDA has not yet determined if the reported false positives are related to the ZIKV Detect test or the commercial testing facility, it is important to remember that IgM tests remain useful in ruling out Zika exposure but require confirmatory testing.
Learn more about InBios International, Inc.’s ZIKV Detect test