Canada suspends Allergan's licences for its Biocell breast implants

Health Canada suspends Allergan's licences for its Biocell breast implants after safety review concludes an increased risk of cancer

 

OTTAWA – Health Canada has completed an update to a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and has found that the rate of BIA-ALCL in Canada is significantly higher in patients with macro-textured breast implants compared to other implants. As a result, because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licences for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada).

This means that no one can sell Allergan’s Biocell breast implants in Canada or import them into the country (Set out in the chart below). At Health Canada’s request, Allergan has agreed to voluntarily recall unused Biocell devices from the Canadian market. Allergan’s other breast implant products are not affected by this decision.

Affected products

Licence number	Licence name
3112	NATRELLE SALINE-FILLED BREAST IMPLANTS (TEXTURED)
72262	NATRELLE 410 TRUFORM SILICONE - FILLED BREAST IMPLANTS
72263	NATRELLE SILICONE - FILLED BREAST IMPLANTS - BIOCELL ROUND
87277	NATRELLE INSPIRA TRUFORM 1 (RESPONSIVE) BREAST IMPLANT (TEXTURED SHELL)
87279	NATRELLE INSPIRA TRUFORM 2 (SOFT TOUCH) BREAST IMPLANT (TEXTURED SHELL)

The license suspensions follow Health Canada’s announcement on April 4, 2019, that it intended to suspend Allergan’s Biocell licences unless the company could provide evidence within two weeks to support that the benefits of the use of the devices outweighed the risks.

Health Canada received a response from Allergan on April 17, 2019, which departmental experts reviewed. It was determined that the information provided by the manufacturer was insufficient to support the ongoing licensing of the devices. The department concluded that the potential risks associated with the devices outweigh the potential benefits.

BIA-ALCL is a serious but rare type of non-Hodgkin lymphoma (a cancer that affects the immune system) that may develop many months or years after a breast implant procedure. It is not a cancer of the breast tissue. BIA-ALCL usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue. While the cause is unknown, possible risk factors and causes for the disease include the high surface area of the implants, genetic factors, and long-term (chronic) inflammation around the implant triggered by factors such as bacteria around the implant.

Health Canada has been notified of 26 confirmed Canadian cases of BIA-ALCL, of which 22 (85%) involve Allergan's Biocell breast implants. Based on Canadian confirmed case data and devices sales data provided by the manufacturers, Health Canada estimates that the risks of BIA-ALCL are 1 in 3,565 for Allergan Biocell macro-textured breast implants and 1 in 16,703 for Mentor Siltex micro-textured breast implants. No cases of BIA-ALCL have been reported in Canada with any smooth surface implants.

Health Canada takes patient health and safety very seriously. As a result of the safety review findings, the Department will also:

• work with all breast implant manufacturers to strengthen the “Instructions for Use” of all breast implants on the risk of BIA-ALCL;
• work with stakeholders to develop new information tools to support informed decision-making for individuals considering breast implants;
• continue to monitor for newly reported Canadian cases of BIA-ALCL, including a yearly follow-up with manufacturers of breast implants; and
• take appropriate and timely action if any new health risks are identified related to breast implants.

If you have an Allergan Biocell breast implant or another type of breast implant:

• Removing your breast implants is not recommended if you do not have any signs or symptoms suggesting BIA-ALCL. Patients should discuss the risks and benefits of removal with their healthcare professional.
• If you don’t know what type of breast implant you have, you should speak with the healthcare provider who did your surgery.
• Conduct regular breast self-exams and see your healthcare professional for periodic follow-ups.
• If you experience unusual changes to your breasts, including breast pain, sudden swelling, or a lump, consult a healthcare professional.
• You can find helpful information on the risks associated with breast implants, including the risk of BIA-ALCL, by visiting the breast implant sectionon Canada.ca.

If you are considering getting breast implants:

• You should get information about the risks and benefits of getting breast implants, and discuss them with a healthcare professional.
• If you do decide to get breast implants, have a conversation with your healthcare professional about which type of implant is the best choice for you.
• You can find helpful information about breast implants, including what you should ask the surgeon, by visiting the breast implant section on Canada.ca.

Information for healthcare professionals

• Provide patients with the appropriate information about the risks, including the risk of BIA ALCL, and benefits associated with their options, so that they can make an informed decision before a breast implant procedure.
• Stay informed about the signs and symptoms of BIA-ALCL and the testing tools used to recognize and diagnose BIA-ALCL.
• Report incidents of BIA-ALCL to Health Canada. Include specific details, such as type of implant, symptoms, how BIA-ALCL was discovered, age of patient at implantation, prior implant history, age of patient at discovery, tests conducted to diagnose, staging information, course of therapy and clinical outcomes.

Report health or safety concerns

• Report complaints involving medical devices to Health Canada.
• Stay connected with Health Canada and receive the latest advisories and product recalls.

The world of medical devices is constantly evolving, and the Government of Canada is working to ensure that regulations and guidance keep pace. As part of Health Canada’s Action Plan on Medical Devices, announced in December 2018, the Department is taking steps to strengthen the monitoring and promotion of medical device incident reporting. In addition, to better support women’s health, Health Canada has established a new Scientific Advisory Committee on Health Products for Women.

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991
1-866 225-0709

Barbecue Safety, inspect your metal bristle barbecue brush regularly.

Summer is coming and everyone is pulling out their Barbecues and associated utensils and getting ready for the BBQs for friends and family.
But that metal bristle brush, what was the last time you really had a look at it?  I am asking because
when we continuously use it, the metal bristle brushes that many people use to clean their barbecue grills can lose their bristles. If some how caught in food and accidentally ingested, these metal bristles can cause serious health problems.Barbecue Safety, inspect your metal bristle barbecue brush regularly
Health Canada is suggesting that;
 

To minimize the risk of issues with your metal bristle barbecue brush, you should:

• regularly inspect your brush for signs of damage;
• inspect grills and barbecued food for loose metal bristles;
• regularly replace your brush to help avoid problems associated with wear; and
• stop using your brush if bristles come loose or stick to the grill.

Here is the Health Canada Press Release;

Consumer Product Update: Have you inspected your metal bristle barbecue brush lately?

Starting date:

May 24, 2019

Posting date:

May 24, 2019

Type of communication:

Information Update

Subcategory:

Household Items, Outdoor Living

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public

Identification number:

RA-70033

Last updated: 2019-05-24

Issue

Millions of Canadians enjoy using their barbecues, especially during the warm summer months. Through repeated use, the metal bristle brushes that many people use to clean their barbecue grills can lose their bristles. If accidentally ingested, these metal bristles can cause serious health problems.

What you should do

To minimize the risk of issues with your metal bristle barbecue brush, you should:

• regularly inspect your brush for signs of damage;
• inspect grills and barbecued food for loose metal bristles;
• regularly replace your brush to help avoid problems associated with wear; and
• stop using your brush if bristles come loose or stick to the grill.

What Health Canada is doing

Health Canada and the Retail Council of Canada have commissioned the Standards Council of Canada to develop a voluntary safety standard for barbecue brushes, including metal bristle brushes. The voluntary safety standard will establish ways to reduce the risk that loose bristles will cause injuries to Canadians by defining safety criteria, such as labelling and testing, for these products. A public review of the draft voluntary safety standard is expected to start this summer. The draft National Standard of Canada for barbecue brushes will be published on the CSA Group's website for 60 days for public review and comment.

Health Canada continues to monitor this issue and will take action as required.

Report health or safety concerns

Health Canada advises consumers to check the Government of Canada's Recalls and Safety Alerts website regularly for any recalled products and to report any consumer product-related health or safety concerns.

(613) 957-2991
1-866 225-0709

Media Inquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public Inquiries

(613) 957-2991
1-866 225-0709

Johns Hopkins Hospital hounding low income patients for medical debt – garnishing wages and seizing bank accounts with thousands of lawsuits,

Johns Hopkins Hospital  supposed to support low income patients who are unable to pay for medical services due to no insurance or high deductibles in the insurance. The hospital receives support for these services via tax exemptions and aid. In 2017 alone Johns Hopkins received $164.4 million in tax exemptions and $25 million in rate support to provide charity care, $3.3 million of which was in excess of actual charity care provided.
Despite its reputation as one of the most prestigious medical institutions in the U.S. Johns Hopkins Hospital has a shocking record of hounding low income patients for medical debt – filing thousands of lawsuits, garnishing wages and seizing bank accounts.
That’s the findings of a new research report from the AFL-CIO, National Nurses United, and the Coalition for a Humane Hopkins. To view the report, go to: Taking Neighbors to Court-Johns Hopkins Hospital Medical Debt Lawsuits

The AFL-CIO, nurses and community activists call on Johns Hopkins to immediately:

• Cancel all medical debt lawsuits it has filed against low -income patients.
• Cease the onerous practices of garnishing wages of low-income patients.
• Substantially increase the amount of charity care it provides for low-income patients who are unable to meet the high price of its hospital medical bills.
• Provide information about eligibility to all patients who may qualify for free or reduced medical care at Johns Hopkins facilities. 

Oklahoma Settles for $85 million with Israeli-based Teva Pharmaceuticals for its role in fueling the state’s opioid epidemic.

BREAKING || "We have agreed to an $85 million settlement agreement with Israeli-based Teva Pharmaceuticals for its role in fueling the state’s opioid epidemic." announced AG Hunter on Sunday.

Press Release; 

 

Attorney General Hunter Announces Settlement with Teva Pharmaceuticals

Trial still set for Tuesday against world’s largest drug maker, Johnson & Johnson

OKLAHOMA CITY – Attorney General Mike Hunter today announced an $85 million settlement agreement with Israeli-based Teva Pharmaceuticals for its role in fueling the state’s opioid epidemic.
While the terms of the settlement agreement may take up to two weeks to finalize, the money will go to the state once it’s received. The funds will then be used to abate the opioid crisis in Oklahoma. A future announcement containing the specific terms of the agreement will be made at a later date.
The state’s trial against the remaining defendant and nation’s largest drug manufacturer, Johnson & Johnson, is still set for Tuesday in Cleveland County. The case will be heard by Cleveland County District Judge Thad Balkman.
Attorney General Hunter said the team remains focused on Tuesday.
“Today’s announcement is a testament to the state’s legal team’s countless hours and resources preparing for this trial and their dedication and resolve to hold the defendants in this case accountable for the ongoing opioid overdose and addiction epidemic that continues to claim thousands of lives each year,” Attorney General Hunter said. “Nearly all Oklahomans have been negatively impacted by this deadly crisis and we look forward to Tuesday, where we will prove our case against Johnson & Johnson and its subsidiaries.”
Teva is the second defendant group to settle ahead of Tuesday’s trial. In March, Purdue Pharma settled with the state for $270 million, with the majority of the money going to the Oklahoma State University Center for Wellness and Recovery. The university will use the money to fund addiction treatment and research to stem the ongoing addiction epidemic in Oklahoma and nationwide.
The state’s settlement agreement resolves current claims against Teva Pharmaceuticals, USA, Inc., Cephalon, Inc., Watson Laboratories, Inc., Actavis, LLC., and Actavis Pharma, Inc., F/K/A Watson Pharma, Inc.

Posted on Sun, May 26, 2019 by Alex Gerszewski filed under

• opioid

Pack Food Safety in Your Picnic Basket for This Memorial Day

Fill Your Picnic Basket with Food Safety to Avoid Getting Sick this Memorial Day

Contact:
FSIS Office of Congressional and Public Affairs
(202) 720-9113

WASHINGTON, May 22, 2019 — Memorial Day kicks off the official start of summer. The U.S. Department of Agriculture wants to remind you to prevent foodborne illness before you light up that grill and pack up the cooler. Hot and humid weather combined with outdoor activities, provide the perfect environment for harmful bacteria to multiply on food and make people sick.

Fill your picnic basket with these items that will help keep your summer fun while handling food at your Memorial Day gathering:

• If running water is not available, bring soap, paper towels, hand sanitizer or moist towelettes. This will help keep your hands clean throughout the day especially after handling any raw meat or poultry.
• Avoid cross contamination by using clean plates and utensils. Don’t place cooked food on a plate that once held raw meat or poultry.
• Bring a couple of portable coolers – one for perishable foods and one for beverages– filled with ice. Perishable items like raw chicken, burgers or appetizers like fresh salsa, guacamole or bean salads should be kept at 40⁰F or below.
• Don’t forget the food thermometer! Cook meat and poultry to the safe internal temperatures. Checking the temperature is the only way to know if your food is safe to consume. USDA recommended safe minimum internal temperatures are:
  • Beef, pork, lamb and veal (steaks, roasts and chops): 145°F with a three-minute rest time
  • Fish: 145°F
  • Ground meats (beef, veal, lamb, pork): 160°F
  • Whole poultry, poultry breasts and ground poultry: 165°F
• Bring the right amount of food that you will consume at your picnic, but if you still have some leftovers, don’t leave them outdoors for more than 2 hours.

Foodborne illnesses can be prevented by properly handling food at home or outdoors. Make sure to follow our four steps - Clean, Separate, Cook and Chill - to food safety all year and during special occasions like this Memorial Day holiday.

How can I prevent E. coli infection?

How can I prevent E. coli infection?

1.     Wash your hands thoroughly with soap and running water.
2.     Follow the four steps to food safety when preparing food: clean, separate, cook, and chill.
3.     Use a food thermometer  to make sure meat has reached a safe minimum cooking temperature
4.     Cook ground beef, pork, and lamb to an internal temperature of at least 160°F (70˚C).
5.     Insert food thermometer into the side of the patty, to the center, to check.
6.     Cook beef steaks and roasts to an internal temperature of at least 145°F (62.6˚C) and allow to rest for 3 minutes after you remove meat from the grill or stove.
7.     Check temperature in the thickest part of steaks or roasts.
8. Prevent cross-contamination by thoroughly washing hands, counters, cutting boards, and utensils with soap and water after they touch raw meat.
9.  Do not drink untreated water or swallow water when swimming or playing in lakes, ponds, streams, swimming pools, and backyard “kiddie” pools.
10. Don’t eat raw dough or batter.
11. Drink pasteurized milk and juices.
12. Take precautions with food and water when traveling abroad.

Promotion
First 10 people to respond in the comments will get a coupon to get a meat thermometer shown above for free. You will need to have a facebook account (makes it easier) and capability to purchase from Amazon USA.

What are Escherichia coli?
Escherichia coli (abbreviated E. coli) are bacteria found in the intestines of people and animals and in the environment; they can also be found in foods.

Most E. coli are harmless and are part of a healthy intestinal tract. However, some cause diarrhea, urinary tract infections, respiratory illness, bloodstream infections, and other illnesses. The types of E. coli that can cause illness are spread through contaminated food or water and through contact with animals or people.

Two types of E. coli that cause diarrheal illness diagnosed in the United States are Shiga toxin-producing E. coli (STEC) and enterotoxigenic E. coli (ETEC).

STEC are a group of E. coli that produce Shiga toxin. This toxin causes people to have diarrhea, which can be bloody. When you hear reports about outbreaks of E. coli infections in the United States, they’re usually talking about a type called STEC O157.

ETEC are the leading cause of traveler’s diarrhea and a major cause of diarrhea around the world, especially among children.

CDCMMWR Malaria Could Be Just A Plane RIde Away, Use Anti Malarial Medicine Before Traveling

CDCMMWR Malaria Could Be Just A Plane RIde Away, Use Anti Malarial Medicine Before Traveling

Malaria cases are on the rise and it has now reached an all-time high in the United States. While Malaria could reach critical levels of danger, the best way to prevent malaria is to take #antimalarial medication during travel to countries where malaria is found, even if you suspect that the destination could infect you.

Even with antimalarial medicine, further protect yourself with using mosquito nets during the night and insect repellents during the day.

 

Educate yourself and the family and spend a few minutes reading the new #CDCMMWR highlights malaria trends, risk factors, and prevention. Read more: (link: http://Bit.ly/CDCVA25) Bit.ly/CDCVA25