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Allergan Aesthetics Breast Implants - recalled due to Increased risk of BIA-ALCL, USA

3 years ago

United States

Company name: Allergan Aesthetics
Brand name: BIOCELL
Product recalled: Breast Implants
Reason of the recall: Increased risk of BIA-ALCL
FDA Recall date: June 01, 2020
Recall details: Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify and reach breast implant patients who have, or have had, BIOCELL® breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL. Since July 2019 when the BIOCELL® recall was announced, robust efforts were made to reach patients, however, the Company is still seeking to directly contact all U.S. BIOCELL® patients that have not yet been notified. This is due to incomplete device tracking data for approximately 52,000 BIOCELL® breast implant units.

It is important to note the United States Food and Drug Administration (FDA) has made the following recommendation, "If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider."

Allergan Aesthetics will launch a multi-channel campaign which will include digital and social media advertisements further informing patients of the voluntary recall and directing them to Allergan Aesthetics' www.BIOCELLinformation.com website for education on how to identify their implant type and register their implants.

"Allergan Aesthetics is committed to patient safety and we are continuing to make every effort to make sure that each and every patient is made aware of the BIOCELL® recall, and knows their implant type and implant history," said John Maltman, Vice President of Medical Affairs at Allergan Aesthetics.

If patients are not aware of the BIOCELL® recall previously announced on July 24, 2019, and do not know the type of implant that they have in place or their implant history, they should either:
- Go to www.BIOCELLinformation.com to reach out to Allergan Aesthetics to determine if the company has their implant information.
- Contact their surgeon or hospital where they received implants to determine if the surgeon or hospital has records of their implant information.

Patients who know that they have an Allergan implant, and may not have participated in device tracking previously, or who need to update their information on www.BIOCELLinformation.com. The website will inform them how to register for device tracking, which is strongly advised for all patients, and answer any questions they may have. Patients with BIOCELL® implants or tissue expanders or a history of BIOCELL® implants or tissue expanders should go to www.BIOCELLinformation.com to learn about the BIOCELL® recall, symptoms of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), the importance of breast self-examination and the need for regular breast implant monitoring.

"We are determined to make sure every woman has the information they need related to the BIOCELL® voluntary recall and we will continue to encourage women with breast implants to determine their implant type and opt-in to our device tracking system. Patient education is a priority. We have partnered with the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) on major initiatives to raise awareness regarding the importance of breast implant tracking," said Carrie Strom, Senior Vice President AbbVie and President Global Allergan Aesthetics.

About the GLOBAL BIOCELL® Recall On July 24, 2019 Allergan initiated a voluntary global recall of its BIOCELL® breast implants and tissue expanders. Allergan has continued a global basis to ensure that patients and health care professions are notified about the BIOCELL® recall. The Company issued global press releases and distributed letters directly to healthcare professionals regarding the recall.

To generate awareness and provide a resource for patients, the Company launched a dedicated website, www.BI- OCELLinformation.com, to help patients identify their breast implants and to provide information and resources related to the risk of BIA-ALCL.

Allergan Aesthetics, an AbbVie company will continue to work closely with global regulatory authorities and societies and patient advocacy groups to provide important BIOCELL® information to patients and health care professionals regarding the voluntary recall.

More information on BIA-ALCL: BIA-ALCL is not breast cancer—it is a type of non-Hodgkin's lymphoma (cancer of the immune system). At this time, the likelihood of developing BIA-ALCL is thought to be low, occurring in less than 0.03% of patients with BIOCELL® textured breast implants. However, BIA-ALCL is a serious condition and
can lead to death, especially if not diagnosed early or treated promptly.

Check the full recall details on fda.gov

Source: FDA

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InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the... See More Nimbus Infusion Pump systems dated May 2019 to August 2023.

Evaluation of complaint data has identified several potential product issues:
- Battery Power may potentially affect the performance of the pump by causing an immediate power off event.
- Upstream Occlusion, as noted by the upstream occlusion alarm, occurs when there is a block in flow of the proximal end of the administration set.
- System Errors, as noted by the System Error alarm which causes the pump to suspend the infusion.
- Drug product egress from certain administration set bonding points, which may potentially result in drug product leaking from the device.
- Flow Rate (high or low) which may potentially lead to the pump infusing an inaccurate delivery of the drug.
- Pump Housing design which may potentially result in damage over time to certain areas of the housing responsible for administration set engagement, leading to false occlusions and flow rate inaccuracies.

These product issues were identified through the InfuTronix post-market surveillance system and evaluated through the InfuTronix Corrective Action/Preventive Action (CAPA) system. InfuTronix has determined that the best corrective and preventive action to address the identified product issues and potential outcomes is a redesign of the Nimbus Infusion Pump system. The redesign of the system will allow InfuTronix to improve several aspects of the product including mechanics, electronics, software, and housing design as well as aspects of the administration set. Given the number of anticipated design improvements and the extensive requirement for design, verification, and validation, InfuTronix believes a new premarket notification(s) and clearance from FDA may be required. As such, InfuTronix is seeking to remove the system from the market while these improvements and design changes are being made and a new clearance(s) is obtained.

A health hazard evaluation (HHE) was performed by an independent physician to evaluate routine post-market complaint failure modes associated with the Nimbus family of infusion pumps. The HHE determined that the common device failure modes pose a low risk to users.

The Nimbus Infusion Pump system has been distributed throughout the United States since October 17, 2014 until February 21, 2024. It has never been distributed internationally. Affected devices have the following Unique Device Identification numbers associated with them:
- Nimbus Ambulatory Infusion Pump 00817170020000
- Nimbus II PainPRO 00817170020086
- Nimbus II Flex 00817170020093
- Nimbus II Plus 00817170020161
- Nimbus II EpiD 00817170020376
- Nimbus II EMS 00817170020109

Users may continue to use the Nimbus Infusion Pump system and associated infusion sets during this removal process. Users should be aware of the signs indicating a potential issue with the pump (How to recognize that a device may fail):

- Battery – The infusion pump will brown out (fail-safe). The user will see that the pump has shut off. Additionally, the LED screen may flicker prior to failure, indicating a potential battery issue.
- Upstream Occlusion - Auditory and visual occlusion alarm alerts the user of the occlusion.
- System Error - Auditory and visual system error alarm will alert the user.
- Drug Product Egress – The user may notice leaking drug from the pump pouch or infusion set or feel wetness from the drug product.
- Flow Rate (high/low) - Auditory and visual occlusion alarm for low flow will alert the user of occlusion. The user will notice residual volume remaining at the end of therapy. High flow rate may be associated with shortened infusion times.
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Infutronix has already notified customers with a letter that details the products impacted, reason for the voluntary removal, risk to health assessment, how to recognize the device may fail and actions to be taken by the customer/user.

The continued use of the Nimbus Infusion Pump system and associated infusion sets is safe during this removal process. Users should be aware of the signs indicating a potential issue with the pump as described above, “How to recognize that a device may fail”. As with any use, health care providers (HCPs) should read the Instructions for Use (IFU) and follow those closely to ensure proper performance of the pump with its associated accessory set. Further, HCPs should educate patients on proper use of the pump and accessories, and potential operational concerns. As a reminder to HCPs,

- When replacing batteries, only new batteries should be used. Care should be taken to ensure that old and new batteries are not confused when completing the replacement. When resetting the battery state, HCPs are encouraged to pay close attention to the device indicator lights and LED screen indicating battery life.
- HCPs should take care to clear an occlusion alarm properly. The battery should not be cycled (turned on/off) to clear the occlusion alarm. If the occlusion alarm cannot be cleared, a new pump should be used. Patients should be educated that silencing the alarm does not clear the occlusion.
- Due to the potential ambulatory use of the pump, patients may carry the drug product dispensing pouch in a carrying pack. Patients should be educated that impeding the tubing set or placing pressure on the device (leaning against it, sitting on it) may cause the device to malfunction.
- HCPs are encouraged to educate patients on potential drug leakage and establish appropriate containment protocols for users to follow.

HCPs should ensure users are educated to recognize audio and visual alarms and inspect their device for damage. Any difficulties or abnormalities noted with the pump or accessories should result in immediate discontinued use of the pump and notification to the HCP. Customers of InfuTronix who have Nimbus Infusion Pumps and associated infusion sets in their possession should contact InfuTronix customer service, where they will be instructed on the Return Material Authorization (RMA) process to be followed for returning both the Nimbus Infusion Pumps and associated infusion sets.

Customers who purchase the Nimbus Infusion Pump and/or associated infusion sets from a distributor should contact their distributor directly and receive instructions on the RMA process to be followed. As the device will not be available or supported after June 20, 2024, InfuTronix encourages the healthcare provider to seek alternative methods of drug product infusion appropriate for their patient’s needs, based on their medical expertise, at the earliest possible opportunity. InfuTronix is removing the Nimbus Infusion Pump Systems from the market.

The products will no longer be supported by InfuTronix for either Nimbus Infusion Pumps or related infusion sets beyond June 20, 2024. To return Nimbus products customers should follow the instructions provided in the Medical Device Removal letter that was sent by InfuTronix, contact InfuTronix customer service or their local distributor.

Company name: InfuTronix, LLC
Brand name: Nimbus
Product recalled: Nimbus Pump System
Reason of the recall: Recall due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump systems
FDA Recall date: March 20, 2024

Source: fda.gov
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Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This applies to you or anyone in close physical contact with your mask.

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In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Megadyne Medical Products, Inc.
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Recall link of December 2023: jnjmedtech.com
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In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

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