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Birth Control Injury Report

Even Doctors May Be Clueless About Realities of IUDs Like Mirena

A new study shows the shocking unknowns about long-acting birth control products called intrauterine devices (IUD’s), like Mirena, even amongst the doctors who are prescribing these drugs. Claire Brindis, a director of the Bixby Center for Global Reproductive Health at the University of California, San Francisco, and her colleagues reviewed information from 273 health practitioners (including doctors, nurses, doctor’s assistants and certified nurse midwives).

Brindis and her team specifically took a look at surveys from 2010 and 2012 when family planning agencies had pushed to increase education about IUD’s among health care providers in Iowa and Colorado, where the survey occurred. This study was presented at the American Public Health Association meeting in San Francisco. It was conducted in collaboration with Ashley Philliber and colleagues at Philliber Research Associates, an independent research and evaluation firm in Accord, N.Y.

Only half of the providers interviewed in the study said they considered IUD drugs like Mirena safe and reliable for preventing pregnancy in women who just had babies. In addition, 30 percent of respondents said these IUD’s were not safe for women who recently had abortions. Both of these views conflict with new recommendations from the American College of Obstetrics and Gynecology, which said last year that almost all women, including those who have recently had a baby or abortion, can safely receive IUD’s.

Moreover, the study showed that health care providers at family planning clinics are likely more informed about IUD use than the average doctor. Therefore, the misconceptions among doctors in general could be even more widespread, said Brindis.

This study shows doctors prescribing IUD’s like Mirena don’t know the facts about who can safely use these types of birth control. Does this mean that doctors also don’t know the possible severe and traumatic side effects associated with Mirena? Does this mean that women areunknowingly using this long-term birth control device that could spontaneously migrate or expel from the body, cause pelvic inflammatory disease (PID) or even infertility? Or are flashy marketing campaigns and slogans by Bayer Pharmaceuticals, the manufacturer of Mirena, leading to the influence of doctors?

No matter what the cause of the misinformation, women need to be aware of possible side effects when using Mirena. These serious side effects may include:

• Uterine perforations

• Ectopic pregnancy (a pregnancy in which the fetus grows outside the uterus)

• Intrauterine pregnancy (a pregnancy with Mirena in place)

• Group A streptococcal sepsis

• Pelvic inflammatory disease (PID)

• Embedment of the device in the uterine wall

• Perforation of the uterine wall or cervix

• Infertility, abscesses, erosion of adjacent areas such as the vagina

Women suffering from these side effects have already spurred several lawsuits against the makers of Mirena. The pending lawsuits allege women who used Mirena suffered serious and permanent physical injuries, including sexual issues. The plaintiffs also claim that Bayer misrepresented the drug in its marketing campaign and never failed to divulge the harmful side effects.

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

Women Experience Serious Side Effects While Using Mirena

Most prescription, and even over-the-counter medications, come with a list of warnings about possible side effects. The side effects for women who have used the hormonal intrauterine device (IUD) birth control Mirena are often extremely serious and can even cause lasting or permanent harm, including infertility. One of the most severe consequences is migration of the device, which is explained extensively in this blog post. Women have also experienced other debilitating unforeseen side effects while using Mirena.

Many women have experienced migration of the IUD out of the uterus, but others have also had the device spontaneously expelled from their body. If a woman does not realize that the device has been expelled, she is then left inadvertently unprotected from a pregnancy. According to drugwatch.com, spontaneous expulsion occurs in 6 percent of women and is more likely in women who have never given birth. Symptoms of this side effect include cramping, bleeding or spotting, pain during sexual intercourse and lengthened or absent device strings. (At the end of the vertical piece of the IUD, there is a small loop with attached polyethlyne strings that are used to remove the device. They can also be used to ensure the device is still in place.)

There is a chance that a woman can become pregnant even when Mirena remains in place. This occurrence can cause serious issues for the pregnancy and the woman. Therefore, doctors usually recommend removing the zygote (fertilized egg) immediately. Otherwise the woman may experience a septic abortion, a condition in which the uterus becomes septic, endangering both the woman and the pregnancy. Becoming pregnant while on Mirena can also cause miscarriage and a premature delivery.

Half of the women who become pregnant while on Mirena will have an ectopic pregnancy. Ectopic pregnancies occur when the egg becomes fertilized outside the uterus and are also referred to as tubal pregnancies since the fertilization often occurs in the fallopian tubes. An ectopic pregnancy usually threatens the life of the mother, and women who have ectopic pregnancies often undergo surgery to remove the fertilized egg. This may also lead to infertility.

Pelvic inflammatory disease (PID), another serious side effect of Mirena usage in some women, may also lead to infertility in some cases. PID is a bacterial infection that occurs in the female reproductive system. The infection can damage the uterus, ovaries and fallopian tubes and thus may lead to infertility. PID can occur as quickly as three weeks after insertion of the IUD.

Other less serious, but still unsettling side effects of Mirena usage include, acne, weight change, nausea, mood changes, breast tenderness, vaginal discharge and abnormal bleeding patterns.

These harsh side effects, including the horrifying possibility of becoming infertile, have led to numerous lawsuits against Bayer Pharmaceuticals, the manufacturer of Mirena. These lawsuits claim Bayer knew the dangerous risks of the device before releasing it to the public. The women claim Bayer willfully endangered them and are suing for punitive damages as well as compensation for medical costs and pain and suffering costs.

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

Migration of Mirena IUD Outside of the Uterus Can Cause Serious Medical Problems

Women hoping for an easy, long-acting birth control might believe Mirena, a hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals, is the perfect choice. However, as a large number of lawsuits and women suffering physical harm can attest, Mirena is not as ideal as it seems.

One of the most dangerous side effects of Mirena is the likelihood of the device migrating from its normal positioniuddislodged inside the uterus. This notion is actually disputed by the manufacturer despite the fact that several women, and a study from a reputable healthcare facility, have shown otherwise. Bayer representatives have stated that the migration is a rare occurrence. However, a study published by the Department of Radiology at the Ronald Reagan UCLA Medical Center found that this is actually a “frequently encountered complication.”

When the IUD migrates spontaneously, it can perforate the uterus and enter the abdominal cavity, pelvis, bladder or blood vessels. This can cause pain, infection and damage to other nearby organs. When the IUD migrates, doctors are forced to use ultrasound or x-ray to locate the device and then perform surgery to remove the device. In a few cases, women have had to have multiple surgeries to remove the device since it is sometimes difficult to locate and remove. The risk of perforation of the uterus is increased in women who use Mirena immediately following delivery of a child, and that risk remains elevated for at least six months following delivery. Spontaneousiudperforation migration of Mirena can also cause other side effects including: abscesses, tissue erosion, fertility problems, peritonitis, Pelvic Inflammatory Disease, uterine wall embedment and ectopic pregnancy.

A woman in South Carolina is suing Bayer after her IUD spontaneously migrated. The claim, one of the first Mirena lawsuits in the nation, alleges that the plaintiff was never adequately informed about the danger of migration following insertion of the device. Bayer is working to have the lawsuit dismissed, claiming the woman’s doctor was aware of the migration risk. However, the plaintiff in this lawsuit contends the warnings that accompany the insertion of Mirena include a caution against perforation at the time the device is inserted. The plaintiff in this case said she suffered injuries from perforation of the uterus as a result of Mirena migration well after the device was inserted.

In a brief filed in conjunction with the lawsuit, the “plaintiffs note that it is quite impossible for Bayer to argue on the one hand that spontaneous migration not associated with insertion of Mirena is ‘biologically implausible,’ and on the other hand argue that Bayer’s duty to warn of said event was satisfied,” the brief argues.

At least 16 other women have made similar claims about problems stemming from Mirena migration in lawsuits filed in Morris County, New Jersey.  According to Bayer, additional complaints are also pending in various other state courts.

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

Clever marketing strategy can’t overshadow severe complications of IUD device Mirena

Women living in this fast-paced, instant information age are seeking quick fixes and simple solutions to problems. So in 2000 when the pharmaceutical company Bayer introduced the birth control Mirena, an intrauterine device (IUD) inserted directly into the uterus to prevent pregnancy, as part of its “Simple Style” program targeted toward busy moms, the new birth control choice became an instant hit. The pharmaceutical company continues to market the IUD with the tagline “Keep Life Simple” and upon its release claimed the device would not only serve as a birth control method but also increase libido and make women “look and feel great”.

Bayer’s multi-million dollar advertising campaign of its IUD directly to the consumer helped create a surge in the use of IUD’s in the United States. In 2009, the use of IUDs implanted in American women using birth control had doubled in just two years (about 7.5 percent of all American women using birth control had IUDs.)

The tactical marketing plan received much attention from the Food and Drug Administration (FDA) after it was found that many of the statements in the “Simple Style” program were found to be more flashy than truthful. The program tended to also downplay the side effects of Mirena. These side effects may include:

  • Uterine perforations
  • Ectopic pregnancy (a pregnancy in which the fetus grows outside the uterus)
  • Intrauterine pregnancy (a pregnancy with Mirena in place)
  • Group A streptococcal sepsis
  • Pelvic inflammatory disease (PID)
  • Embedment of the device in the uterine wall
  • Perforation of the uterine wall or cervix
  • Infertility, abscesses, erosion of adjacent areas such as the vagina

The FDA issued an official warning to Bayer in 2009 for overstating the effectiveness of Mirena, while minimizing the risks associated with it. The German pharmaceutical giant had already received a similar warning, along with a large fine, from the FDA regarding how it advertised Yasmin and Yaz products, other birth control products. A fax from The Department of Health & Human Services, the umbrella organization of the FDA, to Fadwa Almanakly, the associate director of advertising and promotions for Bayer, states that FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed the script for the live consumer-directed program entitled “Mirena Simple Style Statements Program.”

The DDMAC found that statements directly from the “Simple Style” program misled women. For example, according to the fax, the “Simple Style” script included the following statements: “Do you ever feel so overwhelmed by your schedule that intimacy is much more of a ‘to do’ on a list than a desire?” and “One strategy that I recommend for busy couples is choosing a birth control method that allows for spontaneous intimacy and which you don’t have to think about every day, such as the intrauterine contraceptive, Mirena.” The DDMAC concluded that these statements, and several others in the script, indicated that the use of Mirena will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. The fax warning goes on to say that these claims misleadingly overstate the proven efficacy of Mirena. The DDMAC noted that Mirena does in fact not involve a daily routine, but they are not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance or intimacy with their partners. In fact, 5 percent of clinical trial patients reported decreased libido as a side effect of Mirena use.

Also included in the warning from the FDA to Bayer, was a concern that the “Simple Style” program was also leading women to believe that Mirena can help patients “look and feel great” by stating during the program that “…figuring out steps to take to simplify your lifestyle while still looking and feeling great. One of those ways is finding a birth control that is compatible with your busy lifestyle.” In the warning, the FDA stated that it is not aware of any evidence suggesting that women who use Mirena look or feel great. It goes on to state that patients using Mirena may experience various side effects such as: irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness and acne. These side effects may thus keep women from “looking and feeling great.”

In the warning, the FDA states that Bayer’s claims that Mirena improves quality of life, such as intimacy or romance increases, or claims that Mirena help women look or feel better, must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. The FDA asked Bayer that if it does have substantial evidence to prove these claims, that they submit them to the FDA for further review.

There are now several lawsuits against Bayer for its false and misleading statements concerning the Mirena IUD. These suits allege claims similar to those concluded by the FDA’s warning in 2009. The pending lawsuits allege Mirena-using women suffered serious and permanent physical injuries, including sexual issues. The plaintiffs also claim that Bayer misrepresented the drug in its marketing campaign and never failed to divulge the harmful side effects.

The lawyers at Nolan Law Group are equipped to handle cases involving injuries from the usage of Mirena. We are currently evaluating Mirena IUD cases. If you or someone you know has suffered after using Mirena,  please Contact Us or call 312-630-4000.

Mirena: An Overview

Mirena is one form of a long-acting birth control called an intrauterine device (IUD). The IUD is globally the most popular form of birth control with an estimated 150 million users. Manufactured by Bayer Pharmaceuticals, Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is one of only two IUD’s approved for use in the United States. In 2009, the FDA expanded Mirena’s approval to treat heavy menstrual bleeding in women already using an IUD.

Mirena must be inserted by a medical provider. The system includes a T-shaped body made from plastic and a cylinder-shaped steroid reservoir. Mirena works by slowly releasing levonorgestrel, the progestin hormone, into the uterus each day. Because Mirena thins the lining of the uterus, it also decreases menstrual bleeding.

Clinical trials have proven that Mirena is extremely effective in preventing pregnancy. In the studies, 1,169 women 18-35 years of age used Mirena for up to 5 years. The pregnancy rate over the 5 years was 0.7 per 100 women, or 0.7 percent. After Mirena was removed, 80 percent of women who wanted to become pregnant were able to do so within a year after removing Mirena.

Unfortunately, the drug does not come without a fair share of serious side effects and problems. Some of the most serious health issues associated with Mirena include migration of the device from the uterus, device expulsion, pregnancy complications if a woman becomes pregnant while the IUD is inserted, ectopic pregnancy (an egg becomes fertilized outside the uterus) and pelvic inflammatory disease (PID). PID can cause infertility. Other less-severe, but still inhibiting side effects, are: acne, weight change, nausea, mood changes, breast tenderness, vaginal discharge and abnormal bleeding patterns.

Several lawsuits have been filed against Bayer for the serious medical, physical and emotional problems resulting from use of Mirena. The lawsuits also specify Bayer knew of the risks and failed to disclose the dangers associated with using the IUD. Bayer is also accused of using deceptive marketing practices in advertising Mirena to the public. The FDA did issue a warning to Bayer for deceiving advertising practices; however, Mirena is still on the market today and available for use.

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

Yasmin/Yaz and Increased Risk Of Gallbladder Injuries

While it is now well-known that the birth control pills Yasmin, Yaz, and Ocella are assocated with increased risk of blood clots, pulmonary embolism, deep vein thrombosis (“DVT”), heart attack, and stroke, recent reports indicate that these birth control pills may also be connected to gallbladder problems as well.

Yaz and Yasmin contain drospirenone, a diuretic that can drastically increase a woman’s potassium levels. This condition is known as hyperkalemia. Increased potassium levels can lead to both blood clots and gallbladder damage.

Recent data suggests a spike in gallbladder disease and the presence of gallstones among otherwise healthy women. The only connection appears to be that these women are all taking one of these drospirenone-containing birth control medications.

Gallstones are formed by a concentration of bile constituents. While the cause of gallstones varies, some stones form when there is too much cholesterol or bilirubin in the bile. (Bile is a liquid that helps the body digest fats.) Other stones form if there are not enough bile salts or if the gallbladder fails to empty properly.

It is believed that Yaz can increase cholesterol levels in bile while simultaneously decreasing gallbladder movement, leading to gallstones.

Recent reports of injuries ranging from chronic gallstones to gallbladder removal surgery are coming from all across the country. In cases of gallbladder removal, a procedure known as a cholecystectomy, the victim can suffer from impaired digestion, bloating, gas, heartburn, constipation or diarrhea. In addition, many of those who undergo gallbladder removal surgery must make drastic changes to their diet and eating habits.

Symptoms that may occur include:

  • Abdominal pain in the right upper or middle upper abdomen:
  • May be recurrent
  • May be sharp, cramping, or dull
  • May spread to the back or below the right shoulder blade
  • May be made worse by fatty or greasy foods
  • Occurs within minutes of a meal
  • Fever
  • Yellowing of skin and whites of the eyes (jaundice)

 

Additional symptoms that may be associated with this disease include:

  • Abdominal fullness
  • Clay-colored stools
  • Excess gas
  • Heartburn
  • Indigestion
  • Nausea and vomiting

If you, or someone you love, experienced any of these symptoms after taking Yasmin, YAZ or Ocella and would like the attorneys at Nolan Law Group to review your case, please contact us.

Eye on Litigation

YAZ lawsuits are increasing throughout the country.  As of recently, a total of 32 federal lawsuits have been filed throughout the United States on behalf of YAZ victims.  These suits state claims sounding in strict liability, negligence, and failure to warn.   

On July 24, 2009, lawyers representing YAZ victims filed a petition with the United States Judicial Panel on Multidistrict Litigation seeking consolidation and centralization of all federal Yasmin and YAZ suits in front of Judge Carr in the United States District Court for the Northern District of Ohio.  Consolidating all of the cases in a multidistrict litigation (MDL) would bring all individual cases in front of one judge for pretrial purposes, such as discovery, depositions, and settlement discussions.  Utilizing an MDL promotes efficiency and consistency—rather than having many individual cases throughout the country, each and every case is grouped in front of a single court prior to trial.  The Panel will hold a hearing on September 24, 2009 to determine if consolidation in the MDL is appropriate.

The suits are against Bayer Pharmaceuticals Corporation and other Bayer related companies—companies responsible for the manufacturing of Yasmin and YAZ products. 

Bayer is a global medical conglomerate which has reported sales in the billions of dollars since the launch of Yasmin and YAZ in the birth control market in 2001.  This birth control has been reported as one of the highest earning drugs manufactured by Bayer in recent years.  In 2008, Bayer made more than $600 million dollars from it! 

Despite the growing numbers of lawsuits against it, Bayer is still raking in huge profits from women who use YAZ and Yasmin.  It recently published its 2009 Second Quarter Financial Report labeling the group of YAZ contraceptives to be its best selling pharmaceutical line with an increase of 4.1% since last quarter.  Its combined sales from these drugs amounted to an astonishing $915 million for just the first half of 2009!  Showing just how large of a company Bayer is, these YAZ products account for about 12.32% of all of Bayer’s pharmaceutical sales during this second quarter of 2009. 

Interestingly, Bayer’s report mentions another type of progestin that may be used in its drugs.  In October 2008, Bayer announced European approval for the launch of a new oral contraceptive using yet another new synthetic progestin called Dienogest.  In its release, Bayer states “For the first time, the use of estradiol in oral contraceptives is made possible with Qlaira® through the combination of estradiol with the progestin dienogest in a unique dosing regimen.”  The product is currently unavailable in the United States; it is only available in certain European countries, including Germany.  However, Bayer states that “further launches are planned for the fall of 2009.”  This will be an interesting development if the drug is approved for use in the United States.   

Two recent articles published in the British Medical Journal confirm the dangerous risks posed by YAZ and Yasmin.  One of those studies assesses the thrombotic risk associated with the oral contraceptive and the other likewise assesses the increased risk of venous thrombosis in women using these contraceptives. 

If you, or someone you love, have experienced birth control side effects from using Yasmin, YAZ or Ocella, and would like the attorneys at Nolan Law Group to review your case, please contact us.

What Makes It Different and the FDA’s Involvement

The popular birth control, Yaz and Yasmin (generically known as Ocella), differ from other oral contraceptives in that they contain a unique progestin component known as drospirenone. Drospirenone, only recently approved for use in the drug in 2001, is not used in any other birth control pill approved in the United States.

Drospirenone creates a risk of increased potassium levels which can lead to hyperkalemia—a condition that, in many people, disrupts normal heart rhythms. Disrupting normal heart rhythms can be fatal: disruption can slow the blood flow through the heart to the point that blood clots form. Blood clots in the heart can lead to heart attack or can travel to other parts of the body—such as the lungs or the brain—thus causing pulmonary emboli or strokes. Therefore, because the birth control pill contains drospirenone, Yaz and Yasmin pose new and additional risks to young women who use oral contraceptives.

The risks associated with this popular birth control pill are severe; many women who took Yaz or Yasmin have died or been seriously injured because of the serious health risks associated with the drug. In fact, the FDA received over fifty reports of Yaz and Yasmin-related deaths between 2004 and 2008, most involving increased levels of potassium and occurring in women as young as 17 years old. Imagine how many went unreported! A growing number of lawsuits have been filed by or on behalf of these women, charging the drug manufacturer with inadequately warning them of the increased risks Yaz and Yasmin pose to those women who use the oral contraceptive.

While the public-at-large and many physicians may not recognize an adverse reaction to drospirenone, the health risks have been known for longer than many realize. In 2002, the British Medical Journal reported some practitioners’ concern about the drug as a result of 40 cases of venous thrombosis among women taking it. Also, in 2003, the Journal published a paper that detailed reports of thromboembolism deaths and injuries thought to be caused by Yaz and Yasmin.

The FDA has been reprimanding Yaz and Yasmin manufacturers for misleading and inadequate television advertising for the drug for quite some time.

In one warning letter to the pill manufacturer, the FDA stated that the 2003 Yaz and Yasmin commercial entitled “Goodbye Kiss” was misleading to consumers. The ad implied to consumers that the drug was clinically superior to other oral contraceptives. The FDA stated that it was unaware of any evidence demonstrating that the drug was superior to other oral contraceptives or that drospirenone was clinically beneficial. More correctly, the FDA was only aware of the added clinical risks associated with Yasmin and Yaz. Second, while the ad noted drospirenone’s tendency to increase potassium, that effect was portrayed as a benefit of the drug rather than its true nature as a significant health risk. The FDA stated “by failing to add the necessary context to clarify that increased blood potassium is a safety risk rather than a clinical benefit, the ad misleadingly represents or suggests that Yasmin is safer than has been demonstrated by substantial evidence or substantial clinical experience.” As a result of the FDA’s 2003 warning letter, the drug manufacturer was ordered to immediately discontinue the television ads and all other similar promotions.

Since then, new commercials for the popular birth control have aired, but not without further FDA involvement. Last October, the FDA again admonished Yaz and Yasmin manufacturers for television advertising for the drug, finding that the ads, again, misled consumers. This time, two separate ads were found to be misleading in violation of numerous regulations because they “encourage[d] use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.” The ads broadened the indications of the drug by implying that it treated not only symptoms of premenstrual dysphoric disorder (PMDD) but also symptoms of PMS, a less serious condition. This was problematic considering the fact that the drug had never been evaluated for treatment of PMS. The most startling aspect of these commercials is the downplaying of the risks involved with taking Yaz and Yasmin: There were distracting visuals, numerous scene changes, and background music playing as the serious health risks were being communicated. The FDA stated “The overall effect of the distracting visuals, graphics, concurrent supers and background music is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.” As a result of this warning letter, the FDA required Bayer, the Yaz and Yasmin manufacturer, to cease running these ads and any similar misleading promotions. Bayer was also required to run correction ads, an uncharacteristic move for the FDA. The new corrective ad is meant to clear up the misconceptions conveyed in Yaz’s previous advertising campaigns. Correcting these misleading ads cost Bayer upwards of $20 million and will hopefully curtail further misleading information about this popular birth control pill.

Discouraging Bayer from running misleading ads may not, however, be as easy as originally thought. Bayer has received yet another warning from the FDA, this time for its sponsored links on internet search engines. The FDA found the Yaz sponsored link to violate various regulations because it omitted risk information associated with the use of the drug, overstated its indications, and did not use the full established name of the drug being promoted. Promotional materials are required to disclose risk and other information about the drug but the sponsored link for Yaz merely states “YAZ Prevents Pregnancy, May Help Moderate Acne and PMDD” and provides a link to the Yaz website. Such a listing is misleading because it fails to mention any risk information, thus implying the drug is safer than it has been shown to be.

If you, or someone you love, have experienced birth control side effects from using Yasmin, YAZ or Ocella, and would like the attorneys at Nolan Law Group to review your case, please contact us.

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