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September 25, 2020: Allison Breast Center Monument Radiology Safety Alert Issued For Mammography Problems Reports FDA

Allison Breast Center Monument Radiology Safety Alert Announced – This Safety Alert is intended for Patients, Health Professionals, Risk Managers, and Radiology.

The U.S. Food and Drug Administration (FDA) has issued a safety alert for patients who had mammograms at the Allison Breast Center at Monument Radiology, located in Richmond, VA, on or after June 17, 2018, due to possible problems with the quality of their mammograms.

Allison Breast Center Monument Radiology Safety Alert Background Information

According to the FDA, the facility did not meet the standards for mammography quality under the Mammography Quality Standards Act (MQSA) of 1992.  Therefore, the facility may not legally perform mammography at this time, as it does not have an active MQSA certificate, reported the FDA.

On August 27, 2020, the FDA directed the facility to notify all patients who received mammograms at Allison Breast Center at Monument Radiology on or after June 17, 2018, along with their referring health care providers, about the problems with the mammography quality at the facility. To date, the facility has not performed the ordered notifications.

The FDA reports that it will continue to monitor this issue and keep the public informed as new information becomes available.

FDA Allison Breast Center Monument Radiology Safety Alert Recommendations

The FDA has made the following safety recommendations to patients and members of the health care community:

  • If you have had a more recent mammogram at a different Mammography Quality Standards Act-certified facility on or after June 17, 2018, follow the recommendations from that facility.
  • If you have not had a mammogram at a different Mammography Quality Standards Act-certified facility on or after June 17, 2018, follow these guidelines:
    • Consider asking for your mammogram and copies of your medical reports from Allison Breast Center at Monument Radiology, and have your mammogram reviewed at another Mammography Quality Standards Act-certified facility to decide if a repeat mammogram or more medical follow-up is needed.
  • As a patient, you or your representatives have the right to ask for your mammograms and copies of your medical reports.
    • Patients who would like to request a copy of their records should submit a written request by mail with the patients full name, date of birth, patients signature, and the address of the location where the patients medical records should be sent.

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July 8, 2020: Postmarket Surveillance Results for Essure Birth Control Issued by FDA

Essure Postmarket Surveillance Results News – The U.S. Food and Drug Administration (FDA) has posted interim results for the postmarket surveillance study of Essure, a permanent implanted birth control device for women. Sales of Essure in the U.S. stopped in December 2018. Implantation of the Essure birth control device is no longer available as of December 2019.

Credit: Bayer

Essure Postmarket Surveillance Results Information

On July 8, 2020, the FDA issued its postmarket surveillance results for Essure. The FDA has continued to recommend that women who have been using Essure successfully can and should continue to do so. But, women who believe the device may be related to certain symptoms they have, such as persistent pain, should speak with their doctor about appropriate steps.

Patients should discuss the risks and benefits of any procedure with their doctor before deciding on the best course of action.

Per the FDA’s Essure update, Terri L. Cornelison, M.D., Ph.D., director of the FDA’s Health of Women Program in the Center for Devices and Radiological Health stated:

Early results show that Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as their permanent birth control. Also, patients with Essure had higher rates of gynecologic surgical procedures—including surgery to remove Essure—than patients who had tubal ligation. Lastly, pregnancy rates are similar for patients with Essure and tubal ligation.

In February 2016, the FDA ordered Bayer to obtain additional data about Essure’s benefits and compare them to laparoscopic tubal ligation. In December 2018, the FDA ordered Bayer to extend the postmarket surveillance study from three to five years. Enrollment in the study has ended, but the five-year follow-up of patients after their permanent birth control procedure is ongoing and patients are still completing their one-year follow-up visits.

FDA has issued multiple updates over the last several years to monitor the safety of Essure. The agency remains committed to sharing new information with the public about the postmarket safety of this device as it becomes available.

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February 12, 2020: Medtronic Initiates Recall for MiniMed Insulin Pumps due to Incorrect Insulin Dosing

Medtronic MiniMed Insulin Pump Recall News – Medtronic has issued a recall for its MiniMed Insulin Pump product due to incorrect insulin dosing.

The U.S. Food and Drug Administration’s (FDA) has classified this as a Class I Recall. Class I Recalls are the most serious types of recalls.

Use of these MiniMed Insulin Pumps may cause serious injury or death.

Medtronic MiniMed Insulin Pump Recall Information

On November 19, 2019, with updates from the FDA as of February 12, 2020, Medtronic initiated a recall for its MiniMed Insulin Pump products due to incorrect insulin dosages. Individuals with Type 1 diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes.

The following information is subject to this specific MiniMed Insulin Pump recall:

  • MiniMed 600 Series Insulin Pumps
    • Model 630G (MMT-1715) – all lots before October 2019
      1. May be used by persons sixteen years of age and older
    • Model 670G (MMT-1780) – all lots before August 2019
      1. May be used by persons seven years of age and older
  • Distribution Dates:
    • Model 630G – September 2016 to October 2019
    • Model 670G – June 2017 to August 2019

  • Devices Recalled in the U.S.: 322,005

Per the FDA’s announcement,

Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump’s reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death.

Medtronic has received a total of 26,421 complaints in which their MiniMed Insulin Pump device malfunctioned in the above manner. Medtronic is aware of 2,175 injuries and 1 death related to the affected device.

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July 24, 2019: Allergan Breast Implants Recalled Worldwide

Allergan Breast Implants Recalled Today, July 24, 2019. Dr. Kaveeta Vashisht, Acting Associate Commissioner for the FDA Office of Women’s Health, alerted women’s health care professionals that the FDA has requested Allergan to recall certain breast implants and tissue expanders to protect patients from associated health risks. Specifically, the FDA’s action seeks to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) associated with the use of Allergan’s BIOCELL textured breast implants and tissue expanders.

Allergan Breast Implants Recalled – Product Information

As the result of the FDA’s request, Allergan has agreed to a worldwide recall of the Company’s BIOCELL textured breast implant products, including:

• Natrelle Saline-Filled breast implants;
• Natrelle Silicone-Filled breast implants;
• Natrelle Inspira Silicone-Filled breast implants and;
• Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.

The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction including:

• Natrelle 133 Plus Tissue Expander and ;
• Natrelle 133 Tissue Expander with Suture Tabs.

The FDA has also issued a safety communication for breast implant patients, those considering breast implants, and their health care providers detailing the risks; and what steps patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts.

Breast Implant Lawsuit Information

If you have suffered injuries related to recalled Allergan Breast Implants you may be able to seek compensation based on the manufacturer’s failure to properly design these products, or to adequately warn patients and doctors of breast implant complications. If you or a loved one would like more information regarding Breast Implant Lawsuits, please call our firm toll free at 1-877-934-6274. We promise to bring our more than 35 years of experience representing personal injury victims to bear on your behalf.

October 4, 2016: Flush Syringes B. Cepacia Infection Link – Nurse Assist, Inc. Announces Recall

Flush Syringes B. Cepacia Infection Link Announced – October 4, 2016, Nurse Assist, Inc. announced that the company is recalling all unexpired lots of its I.V. Flush Syringes because the products may be linked to a multi-state Burkholderia cepacia outbreak. The U.S. Centers for Disease Control and Prevention (CDC), indicated that B. cepacia poses little medical risk to healthy people; however, people who have certain health problems, such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to B. cepacia infection. B. cepacia is a known cause of infections in hospitalized patients.

Flush Syringes B. Cepacia Infections – Product Recall Information

According to a Nurse Assist company press release, the recall affects the following flush syringe lots and part numbers:

  • Product Code: 1203; Product Description: IV Flush Syringe, 3ml fill; Lot Number: All unexpired lots
  • Product Code: 1205; Product Description: IV Flush Syringe, 5ml fill; Lot Number: All unexpired lots
  • Product Code: 1210; Product Description: IV Flush Syringe, 10ml fill; Lot Number: All unexpired lots
  • Product Code: 1210-BP; Product Description: IV Flush Syringe, 10ml fill; Lot Number: All unexpired lots

Product Numbers 1203, 1205, and 1210 are packaged 30 syringes to an inner carton and six inner cartons in a case (180 syringes). For product number 1210-BP, 100 syringes are packaged in an inner carton with four inner cartons in a case (400 syringes). Lot code information can be found on the outer case panel, the back panel of the inner carton, and on each syringe label.

The lots being recalled were distributed to customers and distributors between 02/16/16 and 09/30/16. Product can be identified by the labeling on the packaging and device. Nurse Assist is directing customers not to use the product from recalled lots.”

Nurse Assist advises that facilities should discontinue using the recalled product and return it to the supplier stating “Nurse Assist is actively investigating the possible link to the infections with the Food and Drug Administration, the U.S. Centers for Disease Control, and various state health departments to ensure that the products are safe for their intended use. Until an investigation can be completed, Nurse Assist urges all healthcare facilities with affected product to discontinue use and return the product to the supplier.” Facilities can contact the Customer Service Team at 1-800-649-6800 ext. 10.

Call The Weinberg Law Firm For B. Cepacia Lawsuit Information

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Medical Device
Lawsuit News

Allison Breast Center Monument Radiology Safety Alert Announced – This Read More

Essure Postmarket Surveillance Results News – The U.S. Food and Read More

Medtronic MiniMed Insulin Pump Recall News – Medtronic has issued Read More

Allergan Breast Implants Recalled Today, July 24, 2019. Dr. Kaveeta Read More

Flush Syringes B. Cepacia Infection Link Announced – October 4, Read More

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