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Ethicon Media Monitoring 11/13/2018
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Couple Alleges Upsylon Y Mesh Caused Permanent Vaginal Injuries
Nov 12, 2018 | Top Class Actions
By Amanda Antell
Boston Scientific is facing a new transvaginal mesh lawsuit, alleging their Upsylon Y mesh caused a woman permanent complications. -
Conflicts of Interest in Medicine May Hurt Patients
Nov 12, 2018 | The Legal Examiner
By Jane Akre
Science Magazine is reporting about conflicts of interest in medicine that remind us it is a business!
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Couple Alleges Upsylon Y Mesh Caused Permanent Vaginal Injuries
Nov 12, 2018 | Top Class Actions
By Amanda Antell
Boston Scientific is facing a new transvaginal mesh lawsuit, alleging their Upsylon Y mesh caused a woman permanent complications. This transvaginal mesh lawsuit was filed by a couple from Tennessee, alleging their lives and marriage have been drastically impacted by the Upsylon Y mesh product.
Plaintiffs Sophia L. and James L. allege Boston Scientific failed to warn them against the potentially defective nature of the Upsylon Y mesh, including complications it could present.
The Upsylon Y mesh is a transvaginal mesh product that is primarily used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), which are conditions typically caused by weakened pelvic muscle.
POP and SUI often develop soon after intense physical trauma like childbirth, which affects the woman’s ability to control urination or keep pelvic organs from prolapsing outside their body.
The Upsylon Y mesh and other transvaginal mesh products provide additional support, and gives women discrete treatment options for these personal health conditions.
With these benefits in mind, Sophia agreed to have the Upsylon Y mesh implanted to treat her vaginal wall prolapse and had no reason to believe she was at risk for serious side effects. According to the transvaginal mesh lawsuit, the Upsylon Y mesh was implanted in Sophia on Dec. 10, 2014 and reportedly experienced painful side effects soon after.
Upsylon Y mesh is made of a monofilament polypropylene material that is supposed to be biologically safe for patients, but, according to the couple’s lawsuit, can cause potentially devastating side effects in patients.
According to the transvaginal mesh lawsuit, Sophia had experienced significant mental and physical pain and has had to undergo multiple procedures to fix internal damage allegedly caused by the Upsylon Y mesh product.
Sophia further alleges that she had to have the Upsylon Y mesh removed, with surgeons having to repair damage to her pelvic organs, tissue, and damaged nerves. In addition, Sophia says she has had to undergo numerous injuries of the pelvis, spine, and vagina and had to have portions of her female genitalia removed.
Sophia says she will most likely require additional medical procedures, and has been forced to contend with the permanent effects of the transvaginal mesh complications.
Along with her husband, Sophia opted to file legal action against Boston Scientific after discovering other women had also experienced serious transvaginal mesh complications.Overview of Transvaginal Mesh Complications
The FDA recently reclassified transvaginal mesh as high risk devices in January 2016, after tens of thousands of women had reportedly experienced mesh erosion and infection. The FDA had first approved surgical mesh for POP treatment in 2002, and had been used for off label POP treatment since the 1990s.
In 2011, the FDA stated it had received almost 4,000 transvaginal mesh injuryreports between 2005 and 2010. At this time, the FDA had concluded that transvaginal mesh complications were “not rare” and that transvaginal mesh procedures were no more effective than traditional surgery.
Over 100,000 women have reported experiencing serious transvaginal mesh complications, spurring litigation action against Boston Scientific and other manufacturers. Sophia states she would not have agreed to have the Upsylon Y mesh implanted, if she had been aware of the potential transvaginal mesh complications.
This Transvaginal Mesh Lawsuit is Case No. 3:18-cv-00888, in the U.S. District Court of the Middle District of Tennessee, Nashville Division.
https://topclassactions.com/lawsuit-settlements/lawsuit-news/857628-couple-alleges-upsylon-y-mesh-caused-permanent-vaginal-injuries/
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Conflicts of Interest in Medicine May Hurt Patients
Nov 12, 2018 | The Legal Examiner
By Jane Akre
Science Magazine is reporting about conflicts of interest in medicine that remind us it is a business!
You’ve heard reports that doctors are compensated, in many cases in the millions, by the very drug and device makers whose products they recommend. It is almost impossible to take money from a manufacturer and not have a favorable opinion of the company and its products. That’s just human nature!
That has been reinforced many times by studies done at the University of North Carolina, Yale University, the George Washington University and Harvard Medical School, among others.
They show that when doctors are paid by pharmaceutical companies, they’re more likely to prescribe drugs made by those companies.
Science Magazine in its July 2018 issue, peels back the conflicts that exist in the U.S. Food and Drug Administration expert panels. It is their job to review new devices and drugs that makers have poised ready to launch on the market.
Once the panel gives its okay, the FDA generally follows their recommendations.
FDA expert panels are made up of scientists, researchers and medical practitioners who are in a position to know, but also in a position to drive sales of any particular product. However, when cash is flashed in the form of consulting contracts, or speaking gigs, they often fail to apply their critical thinking skills.
One hematologist-oncologist, Dr. Vinay Prasad, tells Science. “It’s in their best interest to play nice with these companies.”
How often do these conflicts occur?
Using disclosures posted by the Centers for Medicare & Medicaid Services from 2013 to 2016, 40 of 107 physician advisors received more than $10,000 in earnings or research support from pharmaceutical companies. Twenty-six received more than $100,000. Seven received more than $1 million.The top 17 earning advisors received support either in personal payments or research funding paid by the drug companies amounting to $26 million.
The FDA never disclosed many of the top committee members received funding from drug companies in years prior to serving.
Compare this to Europe.
The European Medicine Agency prohibits the appointment of advisory committee members who have had any financial relationship with pharmaceutical companies three years prior to being on a panel.
Carl Elliott, a medical ethicist at the University of Minnesota says, “Even in the best of circumstances, disclosure is a remarkably weak way of controlling conflicts of interest. A better way would simply be for the FDA to say, ‘We are not taking anybody with any kind of conflict on an advisory committee’.”
Taking a look at the mesh world, when a panel on morcellators was being convened, Dr. Andrew Brill was scheduled to be on the 2014 advisory panel. But Dr. Brill withdrew his name at the last minute. Turns out the San Francisco gynecologist received nearly $100,000 in consulting fees from Johnson & Johnson in 2013. The general cutoff that defines a conflict of interest is $50,000 under FDA guidelines.
J&J makes one brand of morcellator.
Dr. Brill however, did appear on the FDA’s 2011 panel convened to look at the safety of transvaginal mesh.
How can you know if your doctor is in conflict with industry?
There are two ways. The Physician Payments Sunshine Act of 2010 requires manufacturers of drugs/devices to report payments to doctors and teaching hospitals. You can check that out on Open Payments and look up your doc on the Search Tools.
ProPublica, investigative journalism in the public interest, also has a database of payments to physicians. Dollars for Docs is user friendly, easy to read and is based on data required under the Physician Payment Sunshine Act.
For example, look up Pelvic Organ Prolapse and see the top docs who received money from Boston Scientific in 2016—$3.4 million with Dr. Dennis Miller the top recipient at $1.16 million.
Dennis Miller is the father of the Pinnacle pelvic organ prolapse mesh implant.
Pinnacle, a pelvic mesh used to shore up a pelvic floor and organs, was found to be defective in this country and was recalled by the FDA.
Not to be deterred, Dr. Miller’s payments shown total more than $206- thousand from Boston Scientific as recently as December of last year and nearly $6 million in payments from Boston Scientific for royalty or licenses with the company.
That may not be a factor in deciding which doctor will provide your care, then again, it is information you might want to take into consideration about the objectivity of your medical provider.
https://herniamesh.legalexaminer.com/health/medical-malpractice/conflicts-of-interest-in-medicine-may-hurt-patients/
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