Johnson & Johnson accused of failing to warn patients at higher risk from vaginal mesh

Company allegedly knew devices posed added risk for patients with compromised immune systems

The pharmaceutical giant Johnson & Johnson allegedly failed to warn women that its vaginal mesh devices posed a particular risk for patients with compromised immune systems, despite it being well known before they were first sold in Australia.

The federal court is currently deliberating on a landmark class action involving hundreds of women who have sued the multinational giant over the impact of its vaginal mesh devices.

The mesh was surgically implanted to treat stress urinary incontinence and pelvic organ prolapse, common complications of childbirth. It was marketed to surgeons as a simple, safe and affordable implant, which would boost their profits and speed up operations considerably.

But the devices left many women in debilitating pain and unable to have sex, ruining lives and causing long-term impairment.

Over a six-month hearing, the federal court heard allegations that Johnson & Johnson either knew of the risks or failed to properly test the devices before launching them on the Australian market.

On Monday, the women won the right to add a new allegation to its case: that Johnson & Johnson knew the devices posed an added risk for patients with compromised immune systems but failed to warn women.

Kathryn Gill, the lead applicant in the case, was among those who were not warned, the court heard.

Gill suffered from psoriasis but says she was not told of the added risk she faced in undergoing the surgery. She said she never would have gone ahead with the procedure had she known.

It was not until after Gills operation that warnings about immune problems were added to the instructions for a number of the mesh devices.

The warning read: In patients with compromised immune systems or other conditions that would compromise healing, the risks and benefits should be carefully weighed.

The court was also told that US regulators wrote to the manager of regulator affairs at Ethicon, Johnson & Johnsons product development arm, in October 1990, well before the products were first sold in Australia. The letter adverted to potentially delayed wound healing in patients with compromised health due to a number of factors, according to the federal court.

The court also heard from a biomaterials expert, Prof Paul Santerre, who said it was well known that immune system problems made it more difficult for biomaterials to integrate with tissue. Santerre cited a 1997 report on the issue.

Mesh was not sold in Australia until after 1997.

The allegations about the immune system response were not initially included in the class action against Johnson & Johnson. But lawyers for the women launched a late bid to have them included in their formal pleadings, which was opposed by the company.

Federal court justice Anna Katzmann allowed the pleading to be changed in a judgment handed down on Monday afternoon. She rejected the arguments that doing so would put the company in an unfair position, having already argued its case.

Having given careful consideration to the points raised by both parties, I am not satisfied that the amendments would cause any injustice to the respondents, she said.

Katzmann has also allowed the women to seek an injunction that would prevent the mesh devices being sold or marketed in Australia without a comprehensive warning about the risks.

The company had attempted to argue that was a role best left to the Therapeutic Goods Administration (TGA), an argument Katzmann rejected.

Katzmann has reserved her full judgment in the case and it will be handed down at a later date.

Read more: https://www.theguardian.com/australia-news/2018/apr/10/johnson-johnson-accused-of-failing-to-warn-patients-at-higher-risk-from-vaginal-mesh

Australia investigates implants that left some women with ‘rotting pelvises’

(CNN)Like more than 100,000 Australian women, Linda Schulz had a pelvic mesh implant to treat complications from childbirth that resulted in her bowel and bladder prolapsing.

The mesh was meant to be a quick fix, but the aftermath was worse.
Her right leg went numb almost immediately after the procedure, and after a few weeks the mesh was like a knife constantly cutting her up from the inside.
    “The mesh cut through my vagina wall and came through my skin,”Schulz said. “Any movement, whether I moved my legs or not, felt like a serrated-edge knife was cutting me.”
    In the last year, Schulz, 48, along with hundreds of women experiencing similar complications, petitioned the Australian Senate to investigate their use, hoping for an outright ban and recourse for past procedures.
    After a yearlong inquiry, the Senate released a report Wednesday, recommending that the implant be a “last resort” and raised concern that medical practitioners had not adequately informed their patients and “overused” the procedure “without considering alternative treatment options.”
    The report went on to outline vital recommendations for improved treatment guidelines and medical training, prevention of financial inducements for practitioners, a registry of high-risk implantable devices and an audit of past procedures. It also outlined concern that it is not possible to identify accurately the number of women who have received transvaginal mesh implants in the country.
    “Women that have had those implants, who have those outcomes … have been failed in a monumental way by the system and by certain people in the medical profession who they trusted,” saidSen. Rachel Siewert when she introduced the report Wednesday to the Senate. “I hope that we never have to have another inquiry where we see such suffering from the witnesses.”
    Senate involvement all started when Sen. Derryn Hinch heard stories such as Schulz’s, and was moved to startan inquiry in February 2017.
    “I hope our report convinces them they have been listened to and more importantly they have been believed,” Hinch said at the Senate meeting introducing the report.
    Hearings were held across Australiain 2017, interviewing both patients and mesh manufacturers. Hundreds wrote in to the Senate, sharing a range of stories about living with pain after the operation — from not being able to walk, sit or drive to puncturing their partner during intercourse with a splinter that broke off the implant.
    Schulz said she hopes the report will go past recommendations into action, and she hopes no woman has to go through what she did: “It changes your whole life. You don’t feel like a woman anymore. They just take everything in one fell swoop.”

    ‘Horror stories’ in consumer group’s survey

    Clocking in at 20 minutes, the mesh implant is a quick fixaimed at repairing common complications from childbirth and menopause.
    The mesh is implanted to support weakened or damaged tissue to treat poor bladder control and organ prolapse. But the procedure can be risky because of the methods and materials used. According to various studies, complications can include organ perforation, infection, hemorrhage and sexual dysfunction.

    About half of women between 50 and 79 may have prolapse, according to the American Urogynecologic Society. When muscles and ligaments in the pelvic floor get too stretched, for reasons such as childbirth, they fail to hold up the pelvic organs: the bladder, rectum and uterus. The organs can drop into the cavity, making urination and sex painful.
    One in five women has incontinence, or poor bladder control, from childbirth, according to the Journal of Prenatal Medicine.
    Part of the problem in the past, Schulz said, is that there were no hard statistics and records of how many procedures are done and their effects.
    In April 2017, the Health Issues Centre — an Australian consumer advocacy group — conducted its own survey. After asking on Facebook for stories, it heard from 2,500 women in six weeks.
    “We heard horror stories, lives that were completely destroyed,” said Danny Vadasz, head of Health Issues Centre, who also wrote to the Senate, asking for reform. “We were shocked and barely believed something like this could happen in what we considered the world-class health system of Australia.”
    The Australian health care system offers universal health care insurance, paid through taxes, as well as private insurance.
    Based on his survey, Vadasz estimates that in the past two decades, there have been 120,000 to 150,000 mesh implants in Australia, and around 70% of the stories his group heard involved a lack of fully informed consent. Many women, he said, were not even told that a mesh would be implanted into their bodies.

    ‘Mine was badly fitted’

    “As these devices were to be permanent, we are meant to live with rotting pelvises forever,” said Justine Watson, a Sydney resident who submitted her mesh photos to the Senate as part of the inquiry and joined more than 700 Australian women last year in a suit against Johnson & Johnson over claims of flaws in its mesh devices.
    In January, the pharmaceutical giant withdrew its mesh products from the Australian market. That same month, Australia’s medical devices regulator, the Therapeutic Goods Administration, removed mesh products for prolapse.
    Watson’s pain was so severe that she tried to take her own life after being hospitalized multiple times. Doctors didn’t believe her, she said, referring her to psychiatrists instead.
    “Mine was badly fitted,” said Watson, who spent her life savings to travel in October from Australia to the United States to remove the mesh that was first implanted in 2010. “It broke into the wall of my bladder and skewered my urethra.”
    After giving birth to two boys, both weighing more than 8 pounds, Watson struggled with incontinence.
    But within three months of the procedure, Watson was incontinent again and after suffering multiple medical problems,such as fibromyalgia, chronic pain and fatigue, she had the mesh removed. At 47, the procedure left her with the body of an 80-year-old: unwell, overweight and unable to walk more than 100 meters.

    The need for more action

    Both Watson and Schulz said they felt that Wednesday’s Senate report was full of guidelines rather than concrete rules.
    “This (report) feels somewhat ambiguous and can be interpreted several different ways. … It’s very unlikely that it’ll make any difference,” Watson said.
    And eight Australian pelvic mesh implant support groups agreed, saying in a joint statement: “There are a few glimmers of hope for mesh-injured women in the report – but the wording used in the recommendations are so weak that it could, if not followed up by robust policy change, give Australian health authorities, specialists and primary carers permission to carry on as usual. We are disappointed that the recommendations are not stronger, mandating a change in treatment, monitoring and care – especially considering that the report found that: Women are not having their mesh complications identified, or believed, by primary or specialist doctors.”
    Now Schulz, along with others who have been affected, are now looking into a Royal Commission, an official investigation that they hope can fully ban the practice and even offer financial restitution.
    Schulz wants more recognition of the problem. She represents more than 1,600 women in the Australian Pelvic Mesh Support Group, an advocacy organization that warns women about the risks of the procedure.
    In response to the Senate study, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) said, “more needs to be done to protect the safety of women.”
    “It was very clear in the report that women who have experienced adverse complications as a result of a mesh implant have endured long-term pain and reduced quality of life,” said President Professor Steve Robson from RANZCOG, which trains and accredits doctors in Australia and New Zealand.
    Along with agreeing with the recommendation for a registry for high-risk medical devices, he added in his statement: “We support our members by offering clinical guidance and ensure that our College communications and information hubs reflect current national standards.”
    A 2016 study, which compared the results of women across 35 UK hospitals who had surgery with and without mesh, concluded that there was “no benefit to women having their first prolapse repair from the use of transvaginal synthetic mesh.”
    More than 1 in 10 in their study suffered complications, with 3 in 10 needing another operation, leading thestudy authors to recommend the more standard approach, without mesh, where organs are repositioned to their original areas and the supportive tissue surrounding them is repaired and stitched. The Mayo Clinic consistently uses this method.
    There are also less invasive treatments, recommended by some researchers, such as pelvic floor muscle training to strengthen the weakened tissue.
    But for many women, such as Schulz, no other option is given.

    A global issue

    The surgical mesh procedure is controversial and has led to many class-action suits across the United States, UK and Australia.
    In the UK, the National Health Service estimates that over the past two decades, more than 100,000 women have had surgery involving a mesh implant and 3% to 5% have had complications. But a recent study suggested higher figures, estimating that 1 in 15 women had to have her implant surgically removed in the UK.
    Edward Morris, vice president for clinical quality for the Royal College of Obstetricians and Gynaecologists, highlights that based on current evidence, the mesh may be effective to treat incontinence but is not advised for organ prolapse.
    There is still a small subset of women for whom it might be beneficial, he added, given the “appropriate information and counseling about the risks and benefits.”
    The college has a mesh webpage dedicated to information and advice on mesh implants to help women be informed about the procedure.
    In December, the National Institute for Health and Care Excellence — the UK’s health watchdog — withdrew its recommendation for the procedure to treat pelvic organ prolapse, and the Department of Health and Social Care is auditing cases dating to 2005.
    In January, New Zealand banned all vaginal mesh procedures to treat organ prolapse.

    See the latest news and share your comments with CNN Health on Facebook and Twitter.

    In the United States, the Food and Drug Administration has not taken steps to ban vaginal mesh. However, in 2016, it reclassified the device from class II (moderate risk) to class III (high risk), providing the agency with more oversight over the manufacturing of mesh products.
    The FDA estimated that there are 75,000 procedures involving pelvic mesh implants each year in the United States. A 2011 report by the FDA also reported 2,874 cases of injury, death or malfunction related to the use of vaginal mesh between 2008 and 2010, including three deaths: two from bowel perforations and one from hemorrhage.

    Read more: https://www.cnn.com/2018/03/28/health/pelvic-mesh-implant-australia-senate-intl/index.html

    The human microbiome: why our microbes could be key to our health

    Studies suggest the microbes inside us could hold the key to treating a plethora of conditions. Nicola Davis explains why

    What are microbiomes?

    Both inside and out, our bodies harbour a huge array of micro-organisms. While bacteria are the biggest players, we also host single-celled organisms known as archaea, as well as fungi, viruses and other microbes including viruses that attack bacteria. Together these are dubbed the human microbiota. Your bodys microbiome is all the genes your microbiota contains, however colloquially the two terms are often used interchangeably.

    Microbes

    Hang on, arent microbes supposed to be dangerous?

    Its a bit of a spectrum: some are pathogens, but others only become harmful if they get in the wrong place or boom in number, and some are very useful to the body such as by helping to break down the array of sugars found in human breast milk. These sugars are not broken down by the infant, said Prof John Cryan, a neuropharmacologist and microbiome expert from University College Cork. Instead, microbes in the babys gut do the job.

    Other key roles of our microbes include programming the immune system, providing nutrients for our cells and preventing colonisation by harmful bacteria and viruses.

    Where do my gut microbes come from? Do I just pick them up from my surroundings?

    Partly. But it is more complicated than that. It is still a little bit controversial but for the most part it is thought that we are sterile when we are in utero, and as we are being born, as we emerge through the birth canal from our mums, we get this handover bacteria, said Cryan. It is like a gulp at birth. Those bacteria are really important for starting the whole process.

    Cryan notes that during pregnancy a mothers microbiome shifts, apparently to an optimum mix for offspring. If you are not born by vaginal delivery, but are born by [caesarean] section, things start off being different, he said. Indeed, studies have suggested that these differences could be one of the reasons why babies born by caesarean section have a higher risk of conditions including asthma and type 1 diabetes. That said, doctors have cautioned parents against attempting to seed babies born by caesarean section with vaginal bacteria.

    Our gut microbiome changes quickly over our first year or two, shaped by microbes in breast milk, the environment and other factors, and stabilises by the time we are about three years old. But our environment, our long-term diet, stress and the drugs we take, such as antibiotics, continue to play a role as we age, meaning our microbiome can change throughout our life.

    Crime scene microbes

    It seems like microbes are everywhere how many are we talking about?

    The figure that has been bandied out since the 1970s is that microbes outnumber our own cells by about 10 to one. But a study from 2016 suggests that in fact microbial cells and human cells coexist in somewhere around a 1.3 to one ratio suggesting they only slightly outnumber our own cells, although that doesnt count viruses and viral particles.

    Does this mean I am not human?

    Some say we should be seen as a holobiont, a term that reflects the intimate, co-dependent relationship humans have with microbes. I tell this joke that the next time someone goes to the bathroom and they get rid of some of their microbes they are becoming more human, said Cryan.

    But Ellen Clarke, a philosopher of biology at the University of Leeds, is not convinced. It all depends on what you mean by human in the first place, she said. If you think that a human is a collection of cells that all share copies of the same chromosomes, then it is shocking to be told that our bodies contain cells with bacterial DNA.

    But as Clarke points out, human cells dont just contain chromosomes, but also carry DNA within our cellular powerhouses, mitochondria, which are evolutionary descendants of bacteria. Our genome also contains stretches of genetic material called transposons that, at least in some cases, are thought to have been introduced long ago by viruses. I prefer to define a human in evolutionary terms, and if we do this then mitochondria are parts of a human, and so are transposons, but gut microbes are not, and neither are prosthetic limbs nor unborn foetuses, said Clarke, pointing out that microbes can escape the body and live without us.

    Are microbes the same in my gut as on my skin?

    No, different parts of the body the skin, vagina, gut all have very different, distinct communities of microbes. While gut microbes have gained a lot of attention, microbes elsewhere are also important: in recent studies, scientists have found that bacteria commonly found on the skin might help to protect against skin cancer.

    Microbiomes also differ from person to person. When you look at the overall active microbiomes between two healthy people, even if they are living in the same city, you see a tremendous amount of disagreement in their microbiome, said Rob Knight, professor of paediatrics, computer science and engineering at the University of California San Diego and an expert on the human microbiome.

    Variability in the gut microbiome, Knight notes, helps to explain why people respond differently to the same foods. Whether tomatoes are good or bad for you, whether rice is good for you or worse for you than ice cream and so on is explained by your microbiome, he said.

    Why has the microbiome become such a hot topic for research?

    Over recent years the gut microbiome in particular has been linked to a plethora of diseases and conditions, from diabetes to autism and anxiety to obesity.

    The gut microbiome has also been linked to how individuals respond to certain drugs, including how cancer patients respond to chemotherapy, and it has even, tentatively, been suggested that it could be linked with how well we sleep.

    Meanwhile, a range of studies have raised the importance of other aspects of our microbiome, including that the vaginal microbiome is important in whether an HIV-prevention drug applied to the vagina is effective.

    Why do we think the microbiome is linked to all these conditions?

    While some links have come from comparing the microbiomes of different groups of people, such as those with a particular disease compared with healthy individuals, a big player in microbiome research is the germ-free mouse.

    This organism is raised in a sterile environment and can then be exposed to particular microbes, or groups of microbes, to explore their impact. Such studies have been key in raising possible links between the gut microbiome and numerous aspects of our health, including mood and obesity.

    Is it that particular microbes are important, or is it about the microbial community as a whole?

    This is the knotty issue. In some experiments, particular strains of bacteria have been linked to particular effects or conditions, while others have shown that the diversity of the microbiome, or relative abundances of species, is important.

    It is a bit like a rainforest: you might have a very nice fern that is very happy but if that is the only thing in your rainforest and you dont have a diversity it is not going to be good [for the] soil, said Tim Spector, professor of genetic epidemiology at Kings College London and author of The Diet Myth. When it comes to the microbiome, its having the right community of bacteria that are working together and together producing the right chemicals for your body.

    Microbes

    So might microbes be affecting our weight, or even our brains? That sounds a bit sci-fi.

    When it comes to obesity, there are several ways gut microbes might influence matters, including through appetite, production of gases, efficiency of using food, and impact on the immune system and inflammation.

    When it comes to affecting mood, there are also several mechanisms. One is via the vagus nerve, a two-way highway that runs from our brain to various organs in the body, including the gut.

    With the microbiome linked to so many conditions, does tinkering with it promise a whole range of new treatments?

    It is worth being cautious: many studies show associations rather than cause and effect, and some are based only on studies in germ-free mice and have not been explored in humans. Even in mice things arent straightforward effects are not always the same for both sexes and can differ for different strains of mice.

    And there are other factors to consider: For obesity what it looks like is in different human populations, different kinds of microbes are involved in the differences between lean and obese humans, said Knight.

    Spector said: I think everyone is right to be sceptical, and a lot of the links may just be that [microbes] are not necessarily the cause of [a disease], but they might be a secondary effect of it.

    Others say it isnt surprising that our microbiome might be closely linked to our health. All of human development and all the systems in the body have all evolved, or co-evolved, with our microbes, said Cryan. As humans we are very much human-focused and we feel that human cells and genes have primacy, but the microbes were there first.

    Pass the poo

    Does any of this actually affect patients?

    Up to a point. The field has already led to advances in the treatment of C difficile an infection that causes serious diarrhoea and can prove deadly. Patients can now receive faecal transplants from a donor with a healthy microbiome to reset their inner community a procedure that has been shown to rapidly cure the condition.

    Some researchers, including Cryan, believe microbiome research could lead to the development of new mental health therapies. We have coined the term psychobiotic [by which we mean] a targeted intervention of the microbiome for brain health, he said.

    While that may be some way off, Cryan believes it will become routine for doctors to keep an eye on the makeup of patients microbiomes. I think personally that bacteria- or microbiome-derived medicine is the future of precision medicine, he said.

    Lets cut to the chase: what can I do to keep my microbiome in good shape?

    This is where prebiotics and probiotics come in: the former are substances, such as the fibre inulin, on which useful microbes can thrive, while the latter are microbes themselves that are thought to be beneficial for health, such as the Lactobacillus and Bifidobacterium species.

    While both prebiotics and probiotics can be taken as supplements, whether you should shell out for them is another matter: there is little advice on which prebiotics or probiotics people should consume for a particular situation, and when it comes to probiotics it isnt a dead cert that the microbes will colonise your gut when they get there, or if they will offer benefits to already healthy people, such as preventing diseases. That said, if you are taking antibiotics or have IBS, there is some evidence probiotics might be a good idea.

    It is not clear yet whether youre better off just having lots of yoghurt and other fermented foods or actually taking these formulations, said Spector, adding that in general he recommends opting for tweaking your diet to get a dose of probiotics, since it isnt clear which strains individuals should take. The same goes for prebiotics: there is more variety in food in terms of the fibre, therefore more variety in the microbes, he said. Ideally you combine a prebiotic and a probiotic: something like sauerkraut or kimchi.

    What next?

    The spotlight is on unpicking the mechanisms by which microbes are linked to human health. Among the conundrums is how and why the different strains of bacteria have different effects, while researchers are also developing studies to explore how the microbiome influences our response to food, and how different diets can tweak the microbiome. There is also a need to take more of the exciting findings from mouse studies and probe them in humans, preferably through randomised control trials.

    Further reading:

    I Contain Multitudes, by Ed Yong

    Gut: The Inside Story of Our Bodys Most Underrated Organ, by Giulia Enders

    The Psychobiotic Revolution, by Scott C Anderson with John Cryan and Ted Dinan

    Follow Your Gut: How the Ecosystem in Your Gut Determines Your Health, Mood, and More, by Rob Knight

    Illustrations: Pete Gamlen

    Read more: https://www.theguardian.com/news/2018/mar/26/the-human-microbiome-why-our-microbes-could-be-key-to-our-health

    Most Rigorous Study Yet Concludes Abortion Practices In US Are Safe, Restrictions Are Riskier

    A groundbreaking report from the National Academies of Sciences, Engineering, and Medicine concludes – with no margin for rational disagreement – that the abortion procedures used in the United States are safe and effective.

    The 186-page review, available online in its entirety or as a tidy summary, is based on a review of the available clinical and real-world data regarding the medical outcomes and quality of the four current methods – medication, aspiration, dilation and evacuation (D&E), and induction.  

    Moreover, the diverse team of expert authors found no evidence to supporting the benefit of regulations, varying state-by-state, that require abortion-providing clinics to meet stringent facilities criteria, offer pre-procedure counseling, observe waiting periods, and limit which providers can perform the procedures. Their analysis proves that these laws, passed under the thinly veiled claim that they protect women’s wellbeing, accomplish the opposite instead.

    “Abortion is safer when it’s performed earlier in gestation,” Dr Hal Lawrence, CEO of the American College of Obstetricians and Gynecologists, told NPR. “And so delaying and making people wait and go through hoops of unnecessary, extra procedures does not improve the safety. And actually by having them delay, can actually worsen the safety.”

    The recent national decline in abortions has been attributed to the increasing use of long-acting contraceptives, historic declines in the rate of unintended pregnancy, and increasing numbers of state regulations that limit the availability of legal abortion services. Infographic credit: The Guttmacher Institute

    Although all four methods are safe, undergoing an abortion before 10 weeks is the least invasive, as women can simply take one oral dose of the medication mifepristone combined with a vaginal suppository of misoprostol. Thus, any delay to accessing an abortion runs down the clock to a point at which she would need a more intensive procedure that carries a greater risk of complications (and is offered at fewer locations).

    According to the report, about 17 percent of women had to travel more than 50 miles to obtain an abortion due to the scarcity of operating clinics. And 27 states mandate that women receive counseling and then wait a prespecified time (usually 24 hours) before they can return and undergo the procedure. When these logistical situations are combined, as is common in the middle American states, women in need of abortions who lack adequate time away from work/family obligations or reliable transportation (i.e. low-income individuals) may face unjust difficulty.

    When examining what resources an abortion clinic truly needs, the authors determined that the equipment, personnel, and hospital availability necessary for patient safety are no different than what other outpatient medical centers that perform procedures of similar complexity offer. As the majority of abortions are simple, they estimate that 95 percent can be performed in an office setting.

    Finally, the paper calls out the misleading nature of many states’ informed consent requirements.

    “Some states require abortion providers to provide women with written or verbal information suggesting that abortion increases a woman’s risk of breast cancer or mental illness, despite the lack of valid scientific evidence of increased risk,” the authors wrote. 

    Shutterstock

     

    Read more: http://www.iflscience.com/health-and-medicine/most-rigorous-study-yet-concludes-abortion-practices-in-us-are-safe-restrictions-are-riskier/

    My life in sex: Ive had sex only once, 20 years ago

    The one-timer

    Ive had sex only once, 20 years ago. It was reading week at university, so I went to London to stay with my boyfriend. Wed been dating long distance for 10 months, and it had taken me that long to feel ready. That Wednesday, after he left for work, Iwalked to the pharmacy to buy condoms and lube. Then Itidied and made the bed, twitching with nerves.

    I expected it to be painful and awkward the first time, but it wasnt. We kept whispering to each other about how good it felt and how we should have done it sooner. But when we tried to have sex again, we couldnt: it was as if my vagina had slammed shut.

    I was too embarrassed to see a doctor, but Idiagnosed myself with vaginismus, an involuntary clenching of the vaginal muscles that can make it impossible to have penetrative sex. Apparently, its linked to anxiety, but Im not sure what I was so anxious about the possibility of getting pregnant, perhaps, or the fact that, deep down, I knew my boyfriend wasnt right for me. (He later proved it by joining the Conservative party.)

    He was understanding, though, and we stayed together for another five years. Perhaps he was secretly frustrated, and perhaps I should have seen a doctor, but we were both having regular orgasms through non-penetrative sex, so it wasnt a priority.

    I thought Id meet someone else eventually, and work my way up to a full sexual relationship, but Im almost 40 and it hasnt happened yet. I havent sought out a relationship because I feel as if penetrative sex is expected, very quickly, in modern dating. I dont mind too much: being single means no one ever asks me to sit through an episode of Star Trek. And I still have regular orgasms.

    Each week, a reader tells us about their sex life. Want to share yours? Email sex@theguardian.com

    Read more: https://www.theguardian.com/lifeandstyle/2018/mar/02/my-life-in-sex-one-timer-vaginismus

    New mother ‘found bandages’ in her body

    Image copyright Alexandra Loredana
    Image caption Alexandra Loredana with her baby Dominic

    The NHS is investigating claims by a new mother who says she found bandages in her body seven weeks after giving birth at Wexham Park Hospital, Slough.

    “I took out a large piece of decomposing material from inside me that was soaked in blood,” Alexandra Loredana told BBC News.

    Ms Loredana added that she had suffered from thrush and ‘light vaginal wounds’.

    A hospital trust spokesman told the BBC: “We are aware. We have started an investigation.”

    Image copyright Alexandra Loredana
    Image caption Alexandra Loredana says the bandages were inside her body seven weeks after childbirth

    The new mother, from Slough, Berkshire, gave birth to baby Dominic in January.

    Ms Loredana said she initially explained to her midwife how she felt uncomfortable going to the toilet and that something smelled terrible – her midwife checked her stitches and said ‘everything was fine’.

    The new mother said she was unable to get an appointment with her local walk-in centre until 7 March, 2018.

    She said: “For seven weeks I changed my pads more than 10 times a day. Whether I had bleeding or not I just wanted my pads to absorb the horrible smell.

    “Last night I had a bath for the first time and I felt courageous enough to wash with my fingers inside my vagina to clean it.

    “I was breathless when I took out a large piece of decomposing material from inside me that smelled horrible and was soaked in blood.

    “How did this happen?”

    Ms Loredana then went to the accident and emergency department at the same Slough hospital and saw a doctor.

    James Taylor, head of communications at Frimley Health NHS Foundation Trust, said: “I don’t know how frequently these things happen”.

    He said the Trust would make a further statement once it had spoken to Ms Loredana and completed an investigation into the case.

    Related Topics

    Read more: http://www.bbc.co.uk/news/health-43185057

    My life in sex: Its a thrice-weekly session with a dilator

    The cervical cancer survivor

    My life in sex: Its a thrice-weekly session with a dilator

    The cervical cancer survivor

    Read more: https://www.theguardian.com/lifeandstyle/2018/feb/16/my-life-in-sex-cervical-cancer-survivor-vaginal-dilator

    Mom can’t stop laughing after learning the word for vagina farts

    Regardless of its definition, the word queef will continue to bring bouts of laughter to anyone who hears it. 

    This is simply a fact, and it’s been once again proven true by Twitter user _andreaacruzz’s mother.

    “I told my mom what a queef was yesterday and this was her reaction,” Cruz wrote on Twitter. “If you want a good laugh, enjoy this.”

    In the clip, Cruz’s mom is brought to happy tears over her newfound knowledge, repeating the word over and over again, and getting increasingly hysterical each time.

    Even if you don’t understand a word of Spanish, this woman’s laugh is infectious, and it’s hard to not smile at her entertainment. Essentially the woman says that she thinks she may have peed her pants from crying so hard, but that it also resulted in a great workout. 

    While many consider a queef to be flatulence from a  vagina, a.k.a. a vagina fart, that’s not exactly true. Air sometimes makes its way into the vaginal cavity, and when it escapes, the resulting noise sort of sounds like a fart. And that’s why queefs don’t smell rancid like a fart does.

    “Queefs don’t smell because they’re caused by plain old air. They’re basically the vaginal version of making fart sounds with your mouth,” Dr. Vanessa Cullins, vice president of external medical affairs at Planned Parenthood, told Cosmopolitan.

    Read more: https://mashable.com/2018/01/31/queef-mom-cant-stop-laughing-at-the-word/

    Everything That Could Go Wrong for This Drugmaker Did

    Opioids. Vaginal mesh. Testosterone. These have become some of the ugliest words in the pharmaceutical industry, telegraphing medical treatments gone awry, in some cases leaving behind disabled customers, epic legal battles, and vast capital destruction. Some of the industry’s largest companies have been mired in lawsuits and government probes over these issues. But no company has been haunted by the drug industry’s worst nightmares as mercilessly as Endo International Plc.

    Just about everything that can go wrong in the world of pharma has gone wrong at Endo, which makes both branded and generic drugs. Through a dealmaking spree largely led by its former chief executive officer, the company amassed debt of more than $8 billion—five times its market capitalization. That might be tolerable for a high-growth company, but Endo faces cratering prices for generic medicines even as it must deal with a slew of litigation involving its products.

    The new leadership says the Dublin, Ireland-based company can fix all this; it will just take time. “It’s very important to know that we’re not running or hiding from our challenges,” says CEO Paul Campanelli. “We’re well-equipped to handle these types of issues.”

    That includes writing massive checks to get beyond some of Endo’s legal woes. As of November 2017 company officials have agreed to pay more than $3.5 billion in settlements in more than 46,000 suits over its vaginal mesh inserts alone. Endo may have to shell out more to resolve all the mesh cases, according to its U.S. Securities and Exchange Commission filings. Analysts say that should largely contain the problems over the vaginal device, but it will still drain much-needed cash.

    “This is not a growth story,” Gabelli & Co. analyst Kevin Kedra says. “There’s significant pressures, mostly stemming from the debt load, and they’re probably not going to be able to make a significant dent in that until 2019.”

    Campanelli has been slashing costs to help keep Endo’s finances in check. The company now operates with a staff of around 2,700, down from about 6,000 before he took the job in September 2016. It also stopped marketing its opioid pain drugs at the end of 2016.

    Opana
    Photographer: Rich Pedroncelli/AP

    Litigation related to Endo’s marketing of opioids remains the biggest wild card. The drugmaker faces at least 125 cases filed by U.S. state attorneys general, counties, and municipalities, alleging its salespeople downplayed the health risks of the extended-release version of its painkiller Opana while overstating its benefits, according to SEC filings. Other opioid makers, such as Johnson & Johnson and Purdue Pharma LP, face identical claims. The companies have denied the allegations.

    The states and local governments have hired lawyers who helped negotiate the tobacco industry’s $246 billion master settlement in the late 1990s to handle the opioid suits. There’s no exact figure for the damages sought, and estimates of potential damages vary widely. Bloomberg Intelligence litigation analyst Holly Froum figures the total liability for all opioid makers, including Endo, could be as little as $5 billion or as high as $50 billion. “It’s obviously in a very early stage, and these things typically take years to resolve,” Campanelli says.

    The company has shown it can be proactive when the need arises. Its extended version of Opana became the subject of controversy: The drug has been linked to outbreaks of viral infections like HIV as people abusing it spread diseases by sharing needles. U.S. regulators took the unprecedented step last June of asking the company to take the drug off the market. Endo could have appealed that decision, but Campanelli opted to comply—cutting off a drug that racked up around $533 million in sales in a three-year period starting in 2014.

    Campanelli is busy putting out fires that were years in the making. In 2013 the drugmaker hired Rajiv De Silva, an ex-Valeant Pharmaceuticals International Inc. executive and former McKinsey & Co. consultant. At the time, Valeant was blazing a new trail for Big Pharma expansion: buying up other companies, cutting research, and jacking up drug prices. With De Silva as CEO, Endo became a prolific dealmaker, acquiring companies and drug rights—from acquisitions in the hundreds of millions of dollars to vying for assets in the $10 billion-plus range against Valeant. De Silva insisted at the time that Endo wasn’t another Valeant, which ran into massive financial and legal troubles, and said he was doing deals to build a company that didn’t need to rely on deals to grow. He declined to comment for this story.

    De Silva’s biggest acquisition was the $8.05 billion purchase of Par Pharmaceutical in May 2015, which gave Endo a large foothold in the generics business. Endo, which assumed Par’s debt, financed the deal with borrowings and proceeds from a $2.3 billion equity offering. The Par buyout came at the height of the company’s run: Endo’s stock price peaked around $96 in April 2015. That was more than triple the level when De Silva took over. But concerns over litigation and debt, as well as post-Valeant angst over specialty drugmakers, conspired to drive the stock down over the following year. Ultimately, Campanelli replaced De Silva. “We said from Day One, we’re not fixing this in 12 months,” Campanelli says.

    Testim testosterone gel.
    Photographer: Jacqueline Larma/AP Photo

    Another hangover from the De Silva era is Endo’s testosterone litigation. The company faces about 1,300 patient suits claiming its testosterone-boosting gels caused fatal heart attacks in some users. How those suits might fare remains uncertain. Two federal court juries in Chicago last year held AbbVie Inc. responsible for injuries suffered by men taking its AndroGel testosterone booster—a product similar to Endo’s—and awarded a total of $290 million in damages. But one of those verdicts was later thrown out by a judge. In November, Endo’s Auxilium unit won the first case to come to trial over its Testim testosterone gel.

    Still, Endo’s problems could get worse. The company is likely to face many more Opana suits before any settlement is reached, says Richard Ausness, a University of Kentucky law professor, and Endo may be forced to take extreme measures to pay them out. It could adopt the playbook used by companies sued for selling asbestos-laced products in the 1980s and 1990s by setting up a bankruptcy trust to resolve opioid cases, according to Ausness. That would allow the company to hold down settlement amounts, he says.

    “Their debt numbers look terrible. And when you factor in the thousands of opioid suits they may wind up facing, they may have no choice but to ask the bankruptcy courts to help them dispose of those cases,” he says.

    Campanelli has heard the B-word before. “The use of the word ‘bankruptcy’—it’s not something that we’re contemplating at this point in time,” he says. “We’re looking to collaborate to deal with the opioid situation. If we ever got to that process, and I’m not saying that we’re thinking of it, it would be years and years before we would be addressing it.”

    It’s also possible that any opioid manufacturer settlement could be structured in such a way that Endo doesn’t end up underwater. “There could be some giant master settlement—it would just make life that much more difficult for Endo, but I don’t think these state AGs are going to make Endo go out of business,” says Gabelli’s Kedra.

    Despite the financial and legal clouds, Endo officials say they’re concentrating on expanding the business and working on new injectable drugs. The company is also developing one of its key products, Xiaflex, which is used to treat a hand deformity and curvature of the penis, for new uses such as improving the appearance of cellulite. Cosmetic drugs, such as Allergan Plc’s Botox, have turned into powerhouses for pharma companies, and Campanelli has been praising Xiaflex’s prospects. “It fits the model of the new Endo,” he says. Campanelli, however, still has plenty of problems from the old Endo to fix first.

      BOTTOM LINE – Generic drugmaker Endo has agreed to pay billions of dollars in settlements for vaginal mesh suits—and possibly faces much more for testosterone and opioid claims.

      Read more: http://www.bloomberg.com/news/articles/2018-01-26/everything-that-could-go-wrong-for-this-drugmaker-did

      Opinion | Abortion Restrictions Are Sexual Harassment Too

      Before 1973′s Roe v. Wade, the problems were dangerous abortions and unequal access to safe abortions. Forty-five years after the landmark Supreme Court case, we still have the problem of unequal access, now exacerbated by a national, coordinated effort to harass women seeking abortions and their providers, both on the street and through a multiplicity of laws.

      By the time Roe v. Wade ― and its oft-overlooked companion case, Doe v. Bolton ― reached the Supreme Court, the magnitude of the public health problem was obvious. Obvious too was the fact that poor women and women of color were the most likely to land in emergency rooms (5,000 per year in Chicago’s public hospital, for example), and to die as a result of illegal and self-induced abortions,as I wrote about in 1996′s When Abortion Was a Crime.

      In New York City, African-American and Puerto Rican women died due to unsafe abortion at five to 10 times the rate of white women in the 1950s and early 1960s. The racial difference in mortality due to abortion in Georgia was even more dramatic: In 1969, the rate was 14 times higher for black women compared to white women.

      At the same time, legal hospital abortions ― therapeutic abortions performed for medical reasons by physicians with anesthesia and antibiotics ― were, in contrast, extremely safe. 

      Yet in the 1950s and 1960s, only a handful of women could get those safe, legal therapeutic abortions; they were almost exclusively well-to-do white women with private health insurance in private hospitals. Women of color or low-income women who went to public hospitals almost never obtained medical clearance for a legal abortion. 

      The goal of reform laws enacted in a dozen states in the 1960s, first in Colorado and California ― and including the 1968 Georgia law struck down by Doe v. Bolton ― was to reassure doctors who wanted to perform therapeutic abortions that they acted within the law. Doctors, lawyers, women’s rights organizations and other supporters of reform in the 1960s and 1970s lobbied for abortion reform laws with the hope that they would increase the availability of safe, legal abortions.

      Instead, as California’s 1967 reform law showed, the opposite happened. Doctors were more afraid of police and prosecutors going after them; the year before they had seen state officials revoke medical licenses and threaten prosecution of some of the state’s most reputable doctors for performing therapeutic abortions. And instead of allowing an abortion in cases of rape, as permitted by the new law, some local prosecutors rejected these cases, believing the man who denied committing a crime.

      Georgia’s 1968 reform law listed multiple steps before a doctor could legally perform an abortion. The abortion would need to take place in an accredited hospital, be approved by an abortion review committee and be endorsed by two additional doctors. This was an obstacle course designed to restrict legal abortions. Noting that state law required nothing similar for any other surgical procedure, the Supreme Court found the Georgia law unconstitutional in Doe v. Bolton. The case was as important as Roe v. Wade because it made it clear that the system of legal abortion created by reform laws violated the rights of both the patient and the physician.

      Aiding and abetting this sexual harassment are elected lawmakers who pass legislation designed to stigmatize and restrict the constitutional rights of women and reproductive health care providers.

      Doe made the development of independent abortion clinics possible. Clinics were preferable to providing abortions in hospitals because they cut the cost of the procedure and moved it out of the obstetrics ward and away from hostile medical personnel. No one predicted then that anti-abortion forces would use the physical independence of the clinics to surround them with protesters and isolate them from their medical colleagues.

      There is now jeering, name-calling, jostling, shaming, threatening and worse. The anti-abortion movement has led, trained and reveled in the street harassment of female patients and the workplace harassment of abortion providers for decades. Medical students who want to learn how to provide this necessary part of women’s health care are similarly harassed and silenced, as are their teachers.

      Aiding and abetting this gender-based sexual harassment are elected lawmakers who pass legislation designed to stigmatize and restrict the constitutional rights of women and reproductive health care providers.

      Sexual harassment is treating a woman like a sexual object to be played with, ridiculed and touched. It’s aim is to demean her and empower the harasser. Insisting that women carry pregnancies to term against their will is to also treat women like objects without regard for their bodies, health or moral decision-making; it is to use their bodies for power and politics.

      Laws that require women to see ultrasounds of the developing fetus or listen to a heartbeat are harassment. Requiring vaginal ultrasounds by law prior to every abortion is sexual assault.

      Requiring doctors to tell lies about the consequences of abortion is harassment.

      Requiring young women to inform parents of abortions knowing ― hoping ― that this will be humiliating and might induce parental rage or violence is harassment.

      Today laws are designed to close the doors of specific clinics. This includes forcing hospitals to complywith design requirements or requiring a clinic’s physician to have admitting privileges at a nearby hospital (while allowing hospitals to discriminate against abortion providers.) These are new forms of what Doe found to be unconstitutional. Fortunately, the Supreme Court has struck down some of this legislation, known as targeted regulation of abortion providers, or TRAP laws.

      There is other hopeful news, too: young African-American and Latina women are leading the struggle for reproductive justice and sharing their stories to support other women. Funds have been developed in Mississippi to help pay for the cost of travel and child care for women who must travel hundreds of miles to reach the state’s one provider and then stay overnight because of state-mandated waiting periods. Alabama just elected a pro-choice Democrat to the Senate. Five states expanded access to abortion and 11 others expanded access to contraception.

      Since 2010, hundreds of laws restricting abortion have been enacted, particularly in the Midwest and South, in states dominated by the Republican Party. The anti-abortion movement ― with its leaders and co-workers in the Catholic and (white) evangelical churches, right-wing nationalist movement, the Republican Party and, too often, some members of the Democratic Party ―  have been participating in sexual harassment on a grand scale for decades. It is past time to stop it.

      Leslie J. Reagan is a professor of history, law, and gender and women’s studies at the University of Illinois, Urbana-Champaign and the author of When Abortion Was a Crime and Dangerous Pregnancies.

      This piece is part of HuffPost’s brand-new Opinion section. For more information on how to pitch us an idea, go here.

      Read more: http://www.huffingtonpost.com/entry/reagan-opinion-roe-wade-harassment_us_5a63d88ee4b0dc592a096aa1