
Johnson & Johnson Keep Meshing Up & Now Potential to Spread Cancer DEMAND A RECALL
May 1, 2014
Johnson & Johnson’s Ethicon’s Gynecare, the largest maker of devices used in a popular uterine surgery, and the same companies who already have 22,000 pending lawsuits for transvaginal mesh, said they’ve suspended sales of the tools amid concerns about their potential to spread a rare but deadly cancer. These tools go by the names:
Gynecare Morcellex
Morcellex Sigma
Gynecare X-Tract
The health-care giant said it was halting world-wide sales, distribution and promotion of the tools called power morcellators but NOT PERMANENTLY pulling them from the market. Is that because ‘many’ think of these products as the gold standard too?
The action follows a Food and Drug Administration advisory on April 17 discouraging doctors from using the devices to remove fibroids—common but often painful uterine growths—because of a risk of worsening an often-hidden cancer.
WHAT WILL IT TAKE FOR THE FDA TO DEMAND A RECALL?
The FDA has said it plans an advisory committee meeting this summer to examine the tools’ use more deeply. Johnson & Johnson wrote in a letter to customers that it is waiting for the FDA and the medical community to further clarify the role of morcellation in fibroid treatment. The letter was reviewed by The Wall Street Journal.
Morcellators typically use long, tube-shaped blades to cut and remove tissue through tiny incisions, helping patients avoid open abdominal surgery associated with longer scars and recovery. The FDA has estimated morcellators are used about 50,000 times yearly to perform fibroid-removal procedures. Overall, fibroids account for about 40% of the roughly 500,000 hysterectomies performed annually in the U.S., by some estimates.
Fibroids are most often benign. But the FDA cited a 1 in 350 risk that women undergoing surgery to remove these growths have an undetected cancer known as a uterine sarcoma. The risk of spreading this cancer with morcellators—highlighted in a series of Wall Street Journal articles—erupted into a heated gynecological debate late last year after a Boston-area couple began raising an alarm.
Amy Reed, a 41-year-old mother of six and anesthesiologist at Boston’s Beth Israel Deaconess Medical Center, developed advanced uterine cancer shortly after a hysterectomy in October. The hospital that performed the procedure, nearby Brigham and Women’s Hospital, acknowledged that use of morcellation worsened her cancer.
The sales halt doesn’t prevent doctors from using devices already in inventory, and Johnson & Johnson hasn’t recalled those devices from the market. But several hospitals, including Cleveland Clinic and Brigham and Women’s, have suspended morcellator procedures following the FDA’s advisory.
HOSPITALS NEED TO DEMAND REFUNDS and RECALLS
PATIENTS NEED TO DEMAND THE HOSPITALS DO NOT USE
Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract
DEMAND A FDA RECALL
HOLD THE FDA and Johnson & Johnson accountable to patients
Other smaller morcellator manufacturers include Karl Storz GmbH, Olympus Corp. 7733.TO +1.46% and Richard Wolf GmbH. Storz and Wolf didn’t respond to a request for comment about whether they have made any changes following the FDA advisory. An Olympus spokesman declined to comment.
Zoe Roche
Hi,
Reading through this website has disturbed me and I felt compelled to comment. You are so clearly riddled with resentment and rage that you are unable to move on with your life post j and j- which is sad.
You make lots of comparisons between working with Ethicon to being in an abusive relationship. Well what would you say if someone had a website dedicated to an abusive ex boyfriend? Do you think it would be healthy for them to post regular updates on his life? Obsess over what he is doing and Who he is seeing? I think any therapist would tell someone behaving this way to stop. It’s not healthy and its not helping you.
Move on- find something that you love and enjoy doing and focus you energy on that.
Good luck!
Zoe
Melayna Lokosky
Hi Zoe-thanks for reading and taking the time to comment. I also appreciate your concern for my well-being; however, the comment about not being able to move on is inaccurate.
Thinking of a job like a relationship is to help give context but not designed to be an absolute direct parallel.
I’ve successfully gotten past far more significant relationships in my lifetime. I’m a very private person and the decision to come forward was not done easily or in haste.
There are several reasons I waited to start the blog (3 years have passed) and one of those reasons involved making sure I was able to help others by exposing PRSpin and providing tools to hold the guilty accountable.
As I stated in the About section on the blog, this has not been just “my” story but rather “our” story for several years now. Unlike an ex-boyfriend my former company is hurting people (30,000 women with mesh cases in federal court and they’ve killed children.) And if there’s still need for a direct parallel, none of my ex’s killed children or injured 30,000 women.
There is without question, snark, passion,anger at a broken system caused by the lack of accountability from JNJ who pays billion dollar fines to The DOJ and continues the same unethical and illegal activity.
My anger is now channeled with a fierce desire to help people seek justice and bring awareness to all causes that can harm through fraud. My question to you is how aren’t you outraged at the actions of Johnson & Johnson and their executives?
I’ve already taken your advice and found what I love to do (with the guidance of a therapist, a medium, a mother and 10 attorneys-you have no idea how much I wish that was a joke), I love to write and help people. I also have started a consulting company currently on the third beta test.
I truly do appreciate the feedback and take all comments to heart; and, will keep your comments in mind when I write the next JNJ piece. Thank you again for reading and commenting- Melayna