Losartan Recall Expands As Torrent Recalls Five More Lots

The Losartan recall continues to expand after the Food and Drug Administration (FDA) announced the recall of additional lots of the blood pressure medication due to fears of carcinogen contamination. The latest Losartan recall includes five lots manufactured by Torrent Pharmaceutical after the medication was found to contain unsafe levels of N-methylnitrosobutyric acid, or NMBA.

Why is NMBA Dangerous?

NMBA is a known animal carcinogen and believed to be a potential human carcinogen. Like NDEA and NDMA, the compounds found in previous Losartan and Valsartan recalls,  long term exposure to NMBA at unsafe levels could lead to development of certain types of cancers, including:

  • Liver Cancer
  • Stomach Cancer
  • Colon Cancer
  • Intestinal Cancer
  • Prostate Cancer
  • Lower Esophageal Cancer
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Pancreatic Cancer

When Was this Losartan Recall Announced?

The FDA announced the latest Torrent Losartan recall on September 19, 2019, and the company issued a formal announcement of the recall on September 23. This latest recall marks the sixth time that Torrent has recalled lots of its Losartan products due to potential carcinogen contamination since the recalls began in 2018.

Which Lots of Losartan Were Recalled?

The lots included in this latest Losartan recall are listed below:

NDC
Product Name, Strength and Package Count
Batch Number
Expiration Date
13668-409-10
Losartan Potassium Tablets, USP 50mg, 1000 count
4DU2E009
12/31/2020
13668-115-90
Losartan Potassium Tablets, USP 100mg, 90 count
4DU3E009
12/31/2020
13668-115-10
Losartan Potassium Tablets, USP 100mg, 1000 count
4DU3E018
02/28/2021
13668-116-90
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count
BEF7D051
11/30/2020
13668-118-90
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count.
4P04D007
07/31/2020

GoldenbergLaw Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Losartan for at least a year, received a Losartan recall letter, and has been diagnosed with prostate cancer (before age 60), lower esophageal cancer, non-hodgkins lymphoma, leukemia, multiple myeloma, colon, stomach, intestinal, or pancreatic cancer. If you or a loved one has taken Losartan and been diagnosed with one of these cancers, please contact us today for a free consultation. We have over 30 years of experience holding drug manufacturers accountable for negligence, let us deliver the Gold Standard advocacy you deserve.

Allergan Issues Worldwide Recall of Breast Implant Products Due To Cancer Link

The FDA requested that the pharmaceutical company Allergan recall its textured breast implant products after discovering a connection between Allergan’s implants and a rare form of cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). In response, Allergan issued a worldwide recall of all of its textured breast implants and implant-related products.

What Is A Textured Breast Implant?

Allergan manufactures BIOCELL breast implants which include a uniquely textured shell-like surface to prevent the implant from slipping and minimizes scar tissue around the implants.

What Is BIA-ALCL and How Does A Textured Breast Implant Cause It?

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is not breast cancer but actually non-Hodgkin’s lymphoma (cancer of the immune system) that grows within the scar tissue surrounding the implants and may spread throughout the body. BIA-ALCL grows slowly and can usually be treated with surgery to remove the implant and surrounding scar tissue. However, some patients may require chemotherapy and/or radiation therapy.

Textured breast implants have a rougher surface intended to reduce an implant’s movement, but may also lead to the development of cancer cells due to the rough surface causing inflation and irritation to the surrounding tissue.

How Do I know If I Have BIA-ALCL?

Symptoms of BIA-ALCL Include:

  • Pain
  • Lumps
  • Swelling
  • Breast asymmetry

What Is The FDA Saying?

As of May 2019, the FDA said that the risks of BIA-ALCL in textured breast implants did not warrant a national ban. However, as of July 24, 2019 the FDA has issued an updated statement explaining that new data shows a direct link between cancer and specifically textured breast implants manufactured by Allergan.

The data has concluded that more than 80% of 573 lymphoma cases have been linked to Allergan implants and 33 cases have resulted in the patient’s death. In addition, risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.

FDA Principal Deputy Commissioner, Dr. Amy Abernethy, M.D., Ph.D., said in a statement regarding the textured breast implants that, “Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”

How Common Is BIA-ALCL From Textured Breast Implants?

In countries such as France, Canada, and Australia BIA-ALCL from textured breast implants is common due to the products’ domination of the breast implant market by up to 80%. As a result, regulatory bodies similar to the FDA in these nations have already instituted bans on textured breast implants.

However, in the U.S., only 10% of all breast implants are textured breast implants. More specifically, macro-textured implants (the type Allergan manufacturers) are found in less than 5% of the breast implants marketed in the U.S.

Which Products Are Affected?

In response to the FDA uncovering cases of BIA-ALCL and BIA-ALCL-related deaths worldwide and the FDA’s request for a recall of all BIOCELL textured breast implants and tissue expanders marketed in the U.S., Allergan voluntarily issued a worldwide recall of their products.

Allergan’s textured breast implant recall includes:

  • Allergan Natrelle Saline-Filled Breast Implants
  • Allergan Natrelle Silicone-Filled Textured Breast Implants
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Allergan’s textured breast implant-related products include their tissue expander products used by patients prior to breast augmentation or reconstruction procedures:

  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs

What Should I Do Now?

FDA Recommendations:

  • If you do not have symptoms from your breast implant, the FDA does not recommend having the implant removed due to low risk of cancer. However, speak to your health care provider about your concerns
  • Know the symptoms of BIA-ALCL and monitor the area around your breast implants
  • If you experience any symptoms, speak to your health care provider immediately to be evaluated
  • If your BIA-ALCL is confirmed by your health care provider, undergo implant and scar tissue removal surgery
  • Keep a record of the device manufacturer, device identifier, and implant model name (this information may be found on a patient device card from your surgeon or can be requested from your surgeon or the facility where your procedure was performed)
  • Know that most BIA-ALCL cases occur years after breast implant procedure
  • Talk with your surgeon regarding your risk of developing BIA-ALCL

What Should I Do If I Was Diagnosed With BIA-ALCL After Receiving Textured Breast Implants?  

If you or a loved one has been diagnosed with BIA-ALCL after using an Allergan textured breast implant, contact the Minnesota Cancer Attorneys at GoldenbergLaw. With over 30 years of experience fighting corporate negligence, we deliver the Gold standard advocacy you deserve.

FDA RECALL: Serious Complications from Colorectal, Bariatric, or Gastric Surgeries? A Surgical Stapler may be to Blame

On May 16th, 2019,  the U.S. Food and Drug Administration (FDA) required Ethicon, a division of Johnson & Johnson, to recall more than 92,000 Circular Staplers that are used in gastrointestinal and bariatric surgeries.

The FDA has identified this as a Class I recall, the most serious type of recall. They have stated, “Use of these devices may cause serious injuries or death​.”

Who May be Affected

Patients who have had or may undergo gastrointestinal surgery, such as patients with colorectal cancer and bariatric patients.

The FDA Recall Notice states: “The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with these devices.”

What are the injuries?

Potential injuries to patients include:

  • Death
  • Infection
  • Bleeding
  • Need for permanent ostomy “bag”
  • Life-long nutritional and digestive issues
  • Leak in the closure (anastomotic leak)
  • Additional surgeries
  • Need for additional closures (anastomoses)
  • Need for antibiotics
  • Need for additional imaging studies

FDA’s Reason for Recall

The FDA states:

“Complaints of  uncut washers in the stapler and malformed staples occur with their intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity. When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch. Failure to cut the washer suggests complete 360-degree staple line failure.

In addition, an investigation of the manufacturing process detected a shift in a process, which occurred in March 2018 and continued through March 8, 2019, at which time the line was shut down.

The use of affected product may cause serious patient harm or death. Ethicon confirmed serious injuries. Misfiring of the stapler resulted in an additional resection — of the middle rectum in one patient and the lower rectum in another patient — during the planned resection of the upper rectum.”

What Should I Do Now?

If you or a loved one has suffered an injury after colorectal, bariatric, or bypass surgery, please contact the Minnesota Defective Medical Device Attorneys at GoldenbergLaw. With over 30 years of experience litigating complex medical device case, we will deliver the Gold standard advocacy you deserve.