Essure Female Sterilization Device Appears Safe: Study

News Picture: Essure Female Sterilization Device Appears Safe: StudyBy Dennis Thompson
HealthDay Reporter

Latest Womens Health News

TUESDAY, Jan. 23, 2018 (HealthDay News) — Essure implants used in female sterilization have come under fire in recent years, with women reporting a wide array of problems to the U.S. Food and Drug Administration.

A new study from France shows the implants are relatively safe and do not raise the risk of side effects or health problems, however.

The results show that Essure should remain on the market as a viable option for some women who want to avoid pregnancy, said Dr. Eve Espey, chair of obstetrics and gynecology at the University of New Mexico School of Medicine.

“I do hope calmer minds will prevail and we don’t lose a very valuable technique that’s helped lots and lots of women,” said Espey, who wrote an editorial that accompanied the study. Both were published in the Jan. 23/30 issue of the Journal of the American Medical Association.

Traditional female sterilization — “having your tubes tied” — involves laparoscopic surgery. Small tools are inserted through tiny incisions in the abdomen to cut or seal a woman’s fallopian tubes, preventing pregnancy immediately.

Essure implants — small springlike coils — are inserted into the fallopian tubes through the vagina, eliminating the need for any incisions. The procedure can be performed in an office setting in less than 15 minutes.

Once inserted, the coils promote the creation of scar tissue that eventually seals off the tubes. However, the natural process can take up to three months, and in the meantime a woman can still get pregnant through unprotected sex.

Essure is a valuable option for women with health problems serious enough that they might die under general anesthesia, which is required for laparoscopic surgery, said Dr. Charles Ascher-Walsh, director of gynecology and urogynecology for Mount Sinai Hospital in New York City.

It’s also a good option women with prior abdominal surgery and for women with so much excess weight that laparoscopic surgery would be difficult to perform, Espey explained.

Safety concerns related to Essure first arose in 2015 in the United States, the study authors said in background notes. Women began reporting a wide variety of side effects to the FDA, including bleeding, abdominal pain, migraine, depression, allergic reactions, autoimmune diseases and thyroid problems.

The matter has grown so heated that Espey said she saw people protesting Essure right next to anti-abortion protesters when she attended the last annual meeting of the American College of Obstetricians and Gynecologists.

To weigh these safety concerns, researchers, led by Dr. Kim Bouillon of the French National Agency for Medicines and Health Products in Saint-Denis, analyzed data from more than 105,000 French women who received sterilization between 2010 and 2014.

About a third of the women received the Essure implant, and the rest had traditional laparoscopic surgery.

Women who got the Essure implant faced lower immediate risk for complications, about 0.13 percent compared against 0.78 percent for surgery — not surprising, given that the procedure requires no incisions or anesthesia.

However, Essure patients also faced a higher risk that the sterilization wouldn’t take effect — about 4.8 percent compared with 0.69 percent for surgery.

They also were more likely to require another gynecological procedure within a year, about 5.7 percent versus 1.7 percent.

“What they found is what we already knew, that a larger percent of women needed a second sterilization procedure because the first one didn’t work,” Espey said.

But the researchers found no difference in other medical complications and side effects between Essure and laparoscopic surgery.

Espey and Ascher-Walsh doubt that the findings will end suspicion regarding Essure’s safety.

“This will give a little bit more evidence to us when we’re trying to let a patient know it’s not as bad as it sounds, but it’s one chord in a long tune of negativity,” Ascher-Walsh said. “I honestly don’t think it’s going to change too much.”

Espey said she’s most worried that Essure’s manufacturer, Bayer, will decide it’s not worth the trouble and pull the device from the market.

“My concern is it won’t matter what women think or what the research says. If the product goes off the market, it’s gone,” Espey said. “Having a robust method mix is most likely to have the best impact to allow women to plan their families and reduce unplanned pregnancy.”

In a statement, Bayer said it supports the study’s conclusions.

“Bayer believes it is critically important that women and their health care providers are armed with factual, unbiased information regarding permanent birth control options, given there are misconceptions and blatant untruths spread when it comes to all types of birth control, but particularly hysteroscopic surgery,” the company said.

MedicalNews
Copyright © 2018 HealthDay. All rights reserved.

SOURCES: Eve Espey, M.D., chair, obstetrics and gynecology, University of New Mexico School of Medicine, Albuquerque, N.M.; Charles Ascher-Walsh, M.D., director, gynecology and urogynecology, Mount Sinai Hospital, New York City; Jan. 23/30, 2018, Journal of the American Medical Association

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    Annual Flu Pictures Assist Hold Seniors Out of the Hospital

    News Picture: Annual Flu Shots Help Keep Seniors Out of the HospitalBy Maureen Salamon
    HealthDay Reporter

    Newest Senior Well being Information

    MONDAY, Jan. eight, 2018 (HealthDay Information) — The present flu season is shaping as much as be a nasty one, however there’s excellent news for American seniors who’ve gotten their flu shot.

    New analysis exhibits that for older adults, faithfully getting the vaccine every year vastly reduces the percentages of catching a flu so extreme that it lands you within the hospital.

    Researchers discovered that repeated influenza vaccination gives a double profit in older adults, proving 74 p.c efficient in stopping intensive-care (ICU) admissions and 70 p.c efficient in stopping deaths.

    The findings bolster the notion that though getting a flu shot does not at all times stop the flu, it might make it milder for many who do catch it, mentioned research writer Dr. Jesus Castilla. He is a researcher on the Navarra Institute for Well being Analysis in Pamplona, Spain.

    “We have been stunned by the large magnitude of the vaccine impact in stopping extreme influenza,” Castilla mentioned. “Our outcomes present the significance of annual vaccination for stopping extreme influenza within the older inhabitants.”

    “The prevention of extreme influenza was primarily noticed in sufferers repeatedly vaccinated in each the present and former [flu] seasons, which reinforces the advice of annual influenza vaccination within the aged,” he added.

    Tens of millions of People catch the flu yearly, leading to a whole bunch of 1000’s of hospitalizations, in response to the U.S. Facilities for Illness Management and Prevention. Flu-related deaths ranged from 12,000 to 56,000 yearly between 2010 and 2017, in response to CDC estimates.

    Older adults, whose immune techniques aren’t as strong, are extra liable to struggling extreme outcomes from flu an infection, together with hospitalization, problems and dying, Castilla famous.

    “Annual vaccination acts as a booster for his or her immune response,” he mentioned. “In different phrases, the safety will increase as in comparison with the impact of vaccination in a single season.”

    The brand new analysis by Castilla and his colleagues concerned a whole bunch of hospitalized sufferers, older than 65, who had influenza — each extreme and fewer extreme instances — in addition to those that didn’t.

    Individuals who’d gotten a flu vaccination within the present and three earlier flu seasons have been half as more likely to develop a extreme case of the flu, the research discovered.

    “I feel it is reassuring that what we advocate individuals to do — which is to get vaccinated yearly — really does present some extra safety,” mentioned Dr. Marci Drees, who was not concerned with the brand new research. She’s an an infection prevention officer and hospital epidemiologist with Christiana Care Well being System in Wilmington, Del.

    “An important take-home message is to get your flu shot and never fear about how efficient it’s this 12 months,” Drees added, referring to issues that the present U.S. vaccine could be solely marginally efficient.

    “Individuals could be extra inclined to skip it, however this research actually emphasizes main profit is 12 months after 12 months of persistently getting that flu shot helps hold individuals out of the hospital and ICU,” she mentioned.

    Growing every year’s flu vaccine is a difficult enterprise, Drees defined. Well being officers within the Northern Hemisphere examine what strains of the virus circulated most generally within the Southern Hemisphere in earlier months after which adapt the vaccine to these expectations.

    “They should do some little bit of guesswork . . . and do not at all times guess appropriately,” she mentioned.

    Latest research present that flu vaccination cuts the chance of flu sickness by 40 to 60 p.c among the many common inhabitants.

    Drees mentioned she’d prefer to see analysis concentrate on youthful populations, together with kids, to find out if comparable safety is conferred after repeated vaccinations.

    “You are boosting your immune system each time you get that vaccination,” she mentioned. “We all know immunity wanes extra shortly in older individuals, so getting that increase 12 months after 12 months might be contributing to the safety we have seen towards extreme illness.”

    The research is revealed on-line Jan. eight within the journal CMAJ.

    MedicalNews
    Copyright © 2018 HealthDay. All rights reserved.

    SOURCES: Jesus Castilla, M.D., Ph.D., researcher, Navarra Institute for Well being Analysis, Pamplona, Spain; Marci Drees, M.D., M.S., an infection prevention officer and hospital epidemiologist, Christiana Care Well being System, Wilmington, Del.; CMAJ, Jan. eight, 2018, on-line

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      Diagrams used in this presentation were taken from:
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      Histology and Cell Biology, An introduction to Pathology by Albert L. Kierszenbaum and Laura L. Tres (2012) Elsevier
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      Binge-eating disorder linked to other health conditions

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