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Huffington Post and Steven Brill on “America’s Most Admired Law Breaker” J&J
Sep 18, 2015 | Mesh Medical Device News Desk
By Jane Akre
Huffington Post has collaborated with attorney and reporter Steven Brill to produce a 15-chapter expose on Johnson & Johnson. -
Facing Power Morcellator Lawsuit, Device Maker Threatens Legal Action Against Doctor
Sep 18, 2015 | The Legal Herald
By Lawrence P. Banville
...One of the companies, Ethicon, which is a subdivision of Johnson & Johnson, voluntarily withdrew their devices from the market in 2014, and urged doctors to return the device after the possible risk factors were made known to the public. -
What Actually Happens When Your Vagina Falls Out
Sep 18, 2015 | Broadly
By Mish Way
In 2009, Allison Henry sent shudders down many spines with a story she published on the now-defunct website MomLogic.com: Her vagina, she wrote, had fallen out.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Full Text of Stories Below
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Huffington Post and Steven Brill on “America’s Most Admired Law Breaker” J&J
Sep 18, 2015 | Mesh Medical Device News Desk
By Jane Akre
Huffington Post has collaborated with attorney and reporter Steven Brill to produce a 15-chapter expose on Johnson & Johnson. J&J is frequently in the pages of Mesh News Desk as one of the major mesh manufacturers which promises to be the last to settle its outstanding pelvic mesh injury cases. Here Brill digs into the drug Risperdal, given to children with behavioral problems even though the FDA told the company NOT to market it to children. (Check out the Legos campaign marketing to kids).
Here Brill outlines how the muscle of the healthcare giant plowed through the restrictions on any use of its drugs to bring it to blockbuster status. The series is entitled “America’s Most Admired Law Breaker.”
Here is an opening page. Enjoy!
http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/?ncid=edlinkushpmg00000090
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Facing Power Morcellator Lawsuit, Device Maker Threatens Legal Action Against Doctor
Sep 18, 2015 | The Legal Herald
By Lawrence P. Banville
The Karl Storz Group has made it clear that they are taking a firm stance in the debate over the risks associated with power morcellators.
In a strongly worded letter which was sent to Dr. Hooman Noorchashm, the group stated that, “We will no longer tolerate unfounded and unproven allegations such as the ones contained in your previous emails and we will hold you responsible. Should we get to know further public statements from you that our device and/or management would be responsible for your wife’s or any other women’s uterine cancer, and/or any aggravation of their cancerous situation, we would not hesitate to take appropriate legal actions to protect our good name and our rights.”
Dr. Noorchashm and his wife, Dr. Amy Reed, launched a campaign to educate the public and the medical community about the dangers associated with the use of the power morcellator during gynecological surgeries. The pair had chosen to do so because Dr. Reed was diagnosed with leiomyosarcoma which metastasized to other areas of the body after undergoing a procedure to remove uterine fibroids. While the couple has decided to not file a lawsuit, they allege that Dr. Reeds leiomyosarcoma was spread by the use of a morcellator.
Other patients have filed a lawsuit against several morcellator manufacturing companies, including The Karl Storz Group. One of the companies, Ethicon, which is a subdivision of Johnson & Johnson, voluntarily withdrew their devices from the market in 2014, and urged doctors to return the device after the possible risk factors were made known to the public.
In response, Dr. Noorchashm has indicated he has no intentions of stopping his campaign. He stated “This letter exemplifies an entire industry’s sentiments towards a deadly iatrogenic women’s health hazard—namely, upstaging of gynecological cancers using morcellators. Clearly, almost all morcellator companies, including Storz, had recognized that their devices have the potential to spread and upstage cancerous tissues—many of their user’s manuals stated as such.”The FDA’s Safety Warning About Power Morcellators
On November 24th, 2014, the U.S. Food and Drug Administration updated a safety warning that they had previously issued in April of 2014. The updated warning, which addressed the use of power morcellators during gynecological surgeries, reads, “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.”
The FDA estimated the number of women that had undiagnosed uterine cancer and were undergoing hysterectomies and myomectomies to be 1 in 350 where a power morcellator was used.
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What Actually Happens When Your Vagina Falls Out
Sep 18, 2015 | Broadly
By Mish Way
In 2009, Allison Henry sent shudders down many spines with a story she published on the now-defunct website MomLogic.com: Her vagina, she wrote, had fallen out. About ten weeks into Henry's second pregnancy, she suddenly felt like "someone had rammed a pitchfork up [her] butt." She was constipated and bleeding for 15 weeks, like it was perpetually day one of her period. After giving birth to a son, who was fine but premature, one day she noticed while using the bathroom that "there wasn't really a hole there—it felt kind of flat." It was like there was something blocking her vaginal canal. Later that year, she looked down at something more disturbing: "It was like my insides were on the outside and they were coming out." Panicked, Henry went to the doctor and said, "My vagina is falling out of my body!" Because that's exactly what it felt like.
After an emergency appendectomy (which caused gangrene), an untwisted bladder, more surgery, sutures that caused another infection, a complete hysterectomy, and, eventually, a totally new and surgically concocted vagina and labia, Henry walked away from the hospital alive and healthy, with the "vagina of a 13-year-old virgin."
Although "my vagina is falling out!" sounds exciting—and horrifying—the medical term for what happened to Henry is a "complete uterine prolapse." "In general, pelvic organ prolapse is the herniation of pelvic organs to or beyond the vaginal walls," explains Los Angeles–based obstetrician and gynecologist Dr. Jessica Schneider. "With prolapse, support is decreased, and these organs can push down into the vagina."
How could this happen? Basically, all the vital organs in your pelvic region are being held in place by muscles and tissues in your lower belly. During pregnancy and childbirth, these areas are weakened by weight strain in the uterus and, if they do not properly regain strength, can cause the uterus, bladder, rectum, and even small bowel to collapse—causing what's called a prolapse. As the muscles weaken, the organ moves onto the same plane as the vagina or anal canal, and eventually it slips outside of the body, enveloping itself in the canal until it is pushed out of the respective opening. It's as if you're giving birth to your uterus.
Not every case is as extreme as Henry's, and it's not as rare as you might think; according to a study published in the journal Menopause, at least 50% of womenwill experience some kind of genital prolapse after pregnancy. Think about it realistically: When you carry around a nine-pound baby in your uterus and then push it out through an opening the size of a small apricot, there is bound to be some kind of trauma. But it's rarely discussed outside the medical community.
"I think one of the biggest misconceptions is that you can prevent a [prolapse] by having a C-section instead of a delivery," says Dr. Schneider. However, delivery isn't necessarily the problem; simply being pregnant stresses the pelvis and can cause a prolapse.
According to Dr. Schneider, prolapses come in degrees of severity, depending on how far the organ has slipped. "Some women complain that they feel something or have a bulge in the vagina," says Dr. Schneider. "What is falling will determine if there are urinary, sexual, or defecatory dysfunctions." Some women only notice symptoms in certain positions, while others notice a quick increase in pain or discomfort and report things getting worse throughout the day. In only the most extreme cases of prolapse, like Henry's, can one actually see the uterus protruding in the opening of the vagina.
Permanent damage is usually nothing to worry about; doctors can reverse a prolapse with the tools like sutures, mesh walls, pessaries (a removable tool inserted into the vagina that can support organs), and exercises. However, the risk of some kind of pelvic prolapse—of the uterus, bladder, or rectum—gets higher with age, weight, and family history.
Although a prolapse is not life-threatening, it causes physical pain and discomfort as well as psychological trauma. How would you feel if your genitalia suddenly looked, felt, and acted completely different?
"It's hard for all of us to learn something about our bodies and believe that this is temporary," says Jessica Zucker, a Beverly Hills–based clinical psychologist who specializes in women's reproductive and maternal mental health. "We often take the normalcy of our genitals for granted. What I listen to from women is that [a prolapse] can be psychologically harrowing. There is self-blame and embarrassment and shame. It can turn your sexual interest inside out. Right after having a baby, you may not be feeling sexy anyway, and a prolapse can add insult to injury."
"Many women feel self-conscious, uncomfortable in their skin, experience physical pain, and also experience challenges with regard to sexual intimacy," Zucker continues. "The body they once had is no longer, at least for now, and that can be terrifying. People fear not returning to their previous selves—a body that was once comfortable andnow is not. They fear permanent damage and a life of self-consciousness as it relates to sexuality, and beyond."
But this is a reality of the female body: It changes with age and experience. "Women's bodies can be a site of amazing processes, creating and giving life, yet there can be so many things that happen to our bodies in the process of trying to do so," Dr. Zucker says. "The more we talk about things like this, the less shame there will be around them."
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