Hi my name is Nina-Ann I am a twice cancer survivor. Surviving cancer twice is a tough gig. I am sharing my journey to help others. I have written a book also. I am covering cancer, double mastectomy, chemotherapy, family and friends. My blog has lots of information, helpful and a few things to brighten your day. I am a cancer advocate. My story is happy, sad and inspirational.
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60 minutes uncovered this story for mastectomy survivors - news
Last night 60 minutes had this story on implants on mastectomy patients.
My Dad contacted me. You can look the story up on u tube.
If you know anyone that this could effect please pass this on.
HOME » UPDATE: 60 MINUTES REPORT CLAIMS UNAPPROVED PLASTIC SOURCES USED IN BOSTON SCIENTIFIC PELVIC MESHES
UPDATE: 60 Minutes report claims unapproved plastic sources used in Boston Scientific pelvic meshes
Updated to include Boston Scientific’s response to the news piece.
Boston Scientific (NYSE:BSX) stocks fell slightly in pre-market trading after being covered in a 60 Minutes episode focused on gynecological pelvic mesh implants which are the source of a massive multi-district litigation, including claims that the company knowingly purchased inauthentic Chinese plastic materials for production.
The Marlborough, Mass.-based company declined an interview with 60 Minutes, which focused on the devices and the 48,000 suits Boston Scientific faces over the allegedly harmful meshes.
Boston Scientific was quoted as having told 60 Minutes that “nearly one million women have been successfully treated […] We have extensively tested the [plastic] resin to confirm its composition, safety and performance.”
The statement won support from the American Urogynecological Society, but other expert sources interviewed by 60 Minutes had contrasting opinions.
Dr. Michael Margolis, a surgeon who has reportedly removed 350 mesh implants and has served as a witness in lawsuits against Boston Scientific, claimed that the meshes cause a chronic inflammatory reaction.
“The slings I’ve removed are substantially altered in their architecture. They are shrunk by at least 50% in width; they are encased in scar tissue. The pores here, these openings here are shrunk substantially,” Dr. Margolis said, according to 60 Minutes.
The report claims that Boston Scientific won FDA clearance for and used “Marlex” branded polypropylene, made by a subsidiary of Chevron Philips, for its meshes, but in 2004 was warned by Chevron Philips that the branded polypropylene should not be used for permanent implantation.
“I can’t, in my wildest imagination, imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body. It’s well known that its oxidatively unstable,” American Chemical Society fellow, plastics engineer and mesh lawsuit witness Duane Priddy said, according to 60 Minutes.
Boston Scientific was cut off from Marlex by Chevron Philips in 2005, though Boston Scientific appealed to the Texas-based company, according to the report. The medtech firm reportedly had to use the Marlex polypropylene, which it estimated it would run out of by 2012, due to it already having received FDA clearance for the specific material.
Boston Scientific appealed to other suppliers of the polypropylene, and was refused by a second supplier in 2010 based on it being used in medical devices, 60 Minutesreported. The company proceeded in an attempt to “use a middleman with ‘no direct link to BSC’,” according to the report, but were unable to find a buyer.
The company found a source in China, Emai, who had “tons of Marlex imported from Chevron Phillips in Texas,” according to the report.
In pursuit of the Marlex, an agent at Boston Scientific wrote to their superiors asking if they needed to specify that the material would be used in implantable medical devices, and was instructed to not disclose what it would be used for, for fear it “could scare them away”, 60 Minutes reported.
During the same month Boston Scientific was seeking new supplies, the FDA released a report on the meshes claiming they had received approximately 4,000 reports of “injury, death and malfunction” and complications including pain, infection, urinary problems, bleeding and organ perforation, according to the report.
Boston Scientific reportedly analyzed the Chinese source of Marlex, comparing it to authentic Marlex from Chevron Philips, and was told that the packaging and labels, including lot numbers, were fraudulent.
The company continued to investigate the plastic, analyzing 11 parameters between the authentic Marlex and the Emai-sourced Marlex, 60 Minutes reports. Only two parameters were the same, with nine reported as different, with four of those parameters reading as “very different.”
Despite these differences, Boston Scientific concluded that the two plastics were the same, according to the report.
Boston Scientific global sourcing division plastics manager Ann Charest concluded that they “believe this is the right material,” and speculated that the lack of documents were due to being imported through improper channels, and that it may have been “redistributed enough times, the original paperwork has been lost/forgotten,” 60 Minutes reports. The company proceeded to purchase a 30 year supply of the Marlex from Emai.
The news program said it hired Priddy to analyze the medtech company’s tests on the plastic after finding the test results in court documents.
“I would predict a significant difference in the antioxidant stability, or I should say the oxidation resistance of those products in the human body,” Priddy told 60 Minutes. He proceeded to confirm that the product was “inferior,” and indicated the product would only last “a few months” in the human body.
In its efforts to import the Emai-sourced plastics, Boston Scientific reportedly hid the original bags the plastics products came in over fears that “if it is caught by customs, we will be in trouble.”
“A plan to hide the bags in plain wrappers was approved in an email sent from the address of Charles Smith, a director in Boston Scientific’s urology and women’s health division,” 60 Minutes reported.
Images and details on the “overbagging” procedure were distributed to executives to approve, the report claims. The company then told the Chinese government that the plastic had been produced in China, and told US customs that the plastic was made in the US, according to the report.
The FDA investigated the change in plastic, but wrote that it “did not find any indication that the change in [plastic] resin led to an increase in adverse events. We have confidence in our […] findings.,” according to 60 Minutes.
In the 60 Minutes report, Priddy goes on to claim that it was “hard for me to imagine somebody looking at that data and generating an opinion that it is acceptable for use in the human body.”
Though Boston Scientific declined an interview with 60 Minutes, it stated that “any allegations continuing to question the integrity or legitimacy of our [plastic] resin are false and irresponsible.”
The news program, in an attempt to confirm whether or not the company was continuing its use of Chinese plastics, purchased 15 mesh kits and analyzed them at a plastics lab, and confirmed that all of the products matched the supposedly inauthentic Chinese plastic.
Boston Scientific responded to the airing earlier this week, saying that the story included “completely false claims,” and defending that the resin it uses in its current transvaginal mesh products “matches a formulation from the original U.S. produced resin.”
“We believe that this story was irresponsible and misleading. We provided the show with a statement and are disappointed that our perspective, and those of medical societies and the healthcare community, were not fully reflected in the broadcast,” Boston Scientific wrote in its response.
The company claims that the show only offered a one-sided view, and that all commentary came from clinicians and plastic experts “involved with litigious actions,” but did not offer any scientific evidence contradicting the show’s independent lab analysis of the plastics, which it said confirmed that the devices were made from fraudulent materials.
Boston Scientific claimed that its effort to “re-bag” the materials were to present damage during transportation, and said that the move was “well-documented” and “would not have prevented customs officials from opening or further inspecting the bags.”
“Our mesh products contribute to only one percent of annual sales to our company. Continuing to provide these mesh products is not about profits. It is about doing what is right for patients. Without these products, women would be left with few treatment options for these debilitating and often embarrassing conditions. Across Boston Scientific, our employees work diligently to bring forward important medical devices that help people around the world to live longer, healthier lives. We remain steadfast in our commitment to patients,” Boston Scientific wrote.
Someone once wrote"...when i get really cold, or get goosebumbs all over my body, the whole things really scrunch up, like, my entire areola scrunches itself up into a wrinkled little mound. it looks really weird and ugly, and i haven't ever seen other people's breasts do it. what is wrong with my areola/nipples??"The answer:
Well nothing is wrong. This is what my areola does too. It's a normal reaction to the coldness or to irritation / stimulation. The little muscles in the areola do a similar goosebump thing as your other skin can do. People often call this phenomenon "hard nipples".
Also note that skin on areola has less feeling or sensation to it than other areas of your body. If the areola was very sensitive, then breastfeeding would probably be quite uncomfortable because the baby pulls and tugs it! The nipples are sensitive but the sensitivity changes with hormonal changes, such as occur at mestrual cycle or pregnancy. Also this varies with ind…
By Alex Tresniowski
With Her Family by Her Side, Linda McCartney's Long and Winding Journey as Mother, Wife, Artist and Crusader Comes to An All-Too-Untimely End There were 36 phone messages waiting for freelance music writer Danny Fields when he returned to his Manhattan apartment April 19 after a weekend trip. Reporters were calling about the death of his close friend Linda McCartney, who had died two days earlier at age 56 from breast cancer that had spread to her liver. Devastated by what he heard, Fields reached for the phone. "I called Paul right away," says Fields. "I said, 'Oh, Paul,' and his voice cracked for 10 seconds. We both started to cry. But then I couldn't stop, and he was consoling me. He said, 'Wasn't she great? Wasn't she beautiful? Wasn't she smart and together and wonderful and loving?' "
Praising his wife was an occupational as well as an emotional habit for McCartney, 55, who wrote dozens of love song…
In Stage 1 shows the flat breasts of childhood. By Stage 2, breast buds are formed as milk ducts and fat tissue develop. In Stage 3, the breast become round and full, and the areola darkens. Stage 4 shows fully mature breasts.
(Illustration by GGS Information Services.)
period begins. Usually these signs are accompanied by the appearance of pubic hair and hair under the arms.
Once ovulation and menstruation begin, the maturing of the breasts begins with the formation of secretory glands at the end of the milk ducts. The breasts and duct system continue to grow and mature with the development of many glands and lobules. The rate at which breasts grow varies significantly and is different for each young woman. Breast development occurs in five stages: Stage One: In preadolescence, the breasts are flat and only the tip of the nipple is raised.Stage Two: Buds appear, breast and nipple are raised, fat tissue begins to form and the areola (dark area of skin that surrounds the nipple) enlarge…