Tag: irregular bleeding

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Mirena Injuries: Side Effects Impacting Consumers

Mirena intrauterine device manufactured by Bayer Healthcare was first approved by the FDA in 2000 for pregnancy prevention. In October 2009, the flexible hormone-releasing contraceptive was allowed for preventing heavy menstrual bleeding in women using intrauterine birth control devices. However, the reported side effects of the Mirena IUD cast serious doubt on the efficacy of it as a hassle-free, long-term birth control measure. Mirena is found to be stirring a number of serious complications in users, such as uterus perforation, intestinal obstructions, infection, device migration, ectopic pregnancies, abscesses, and pelvic inflammation.

Research Reports on Mirena Side Effect Injuries

The majority of doctors in the United States are hesitant to consider Mirena a safe and effective contraceptive, according to the findings of a survey presented at the San Francisco meet of the American Public Health Association on October 31, 2012. The survey highlighted reports of severe injuries caused by adverse impact of these devices in users. According to it, puncturing of the uterus is the most common side effect and those who have had abortion or just given birth to babies face greater risk of complications.

Another research report published in Obstetrics & Gynecology journal in March 2012 also corroborated existence of similar fears over the device safety. Based on a survey by Centers for Disease Control and Prevention, it disclosed that 60 percent of healthcare professionals suggest using Mirena intrauterine device only occasionally purely because of safety concerns.

The FDA has also admitted to have received reports indicating decreased libido, breast tenderness, ovarian cysts, pain, and bleeding in women during clinical tests involving Mirena IUD.

Mirena Side Effect Injuries: Major Problems

• Change in menstrual pattern: Use of Mirena IUD leads to irregular bleeding and spotting. Users experience shorter menstrual pattern within six months and many stop having periods after 12 months.
• Migration and Pain: The FDA has received a number of complaints highlighting how the Mirena IUD migrated from its original location causing pain, discomfort, and perforations. It slips out of the uterus that effectively ends its birth control efficacy. Many users begin to experience cramps with a week of the device insertion.
• Perforation: Dislocation pushes the Mirena IUD through the uterine wall. Even in normal conditions, insertion causes perforation of the uterus membrane. It can lead to damage to internal organs causing severe inflammation and abscesses. Surgery is the only option to remove the Mirena IUD in such cases.
• Pregnancy: Post-marketing reports and complaints to the FDA have confirmed serious pregnancy-related problems caused by Mirena IUD side effects. Ectopic pregnancy or fertilization outside the uterus is a result of its side effects. Women who used Mirena IUDs earlier face the risk of early labor pain, delivery, and miscarriage.
• Infection: Mirena IUD side effects lead to pelvic inflammatory disease. Inflammation of gonorrhea accompanying infection and abscesses put users at the risk of pelvic diseases.
• Ovarian Cysts: About 12 percent of Mirena IUD users are diagnosed with ovarian cysts. The excess release of levonorgestrel hormone results in asymptomatic enlarged follicles. These cysts can cause painful sexual intercourse and pelvic pain.
• Vaginal Problems: Mirena birth control device users have also complained of vaginal pain, bleeding, sores, watery discharge, smell, etc.

Mirena IUD side effects impact the quality of lives of users. It has been linked to extreme dizziness, abdominal pain, fever, severe headache, and sudden numbness in users. Light sensitivity, jaundice, allergic reactions leading to face and throat swelling, and hives are also observed in users affecting their lives. In January 2010, the FDA warned Bayer Healthcare for overstating the benefits of the Mirena IUD and hiding health risks during its promotional campaigns.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Mirena Problems, Mirena Injuries

As a Mirena lawyer, we receive frequent calls and emails from women alleging injury from the Mirena device. The types of injuries complained of include but are not limited to depression, weight gain, hair loss, ovarian cysts, pelvic inflammatory disease, pregnancy, mood swings, and more.

Our firm represents women that received the Mirena device, but we are limiting are review of cases to women that experienced a perforation of the Mirena device through the uterus that resulted in surgical removal of the device. Many of our clients went back to the doctor 6-8 weeks after the Mirena was initially inserted and received confirmation the device was in place.

The Mirena removal can also cause injury, including paralysis, nerve damage, staph infection, bleeding, and more. Any damages you may experience in the removal process could be deemed related to the initial device perforation.

The bottom line: if you have experienced a Mirena injury, contact us. We may be able to investigate your claim and file a case on your behalf, which could award you compensation for your injuries.

Perforation of the Uterus Claims are possible says Mirena Lawyer

The Mirena device is manufactured by Bayer Pharmaceuticals.  Bayer Pharmaceuticals was formerly known as Berlex, Inc. which was formerly known as Berlex Laboratories.  Nevertheless, Bayer is the holder of the new drug application for the contraceptive device Mirena.

Mirena is an intra-uterine contraceptive system made of flexible plastic that is inserted by a healthcare provider during an office visit.  The Federal Food and Drug Administration (FDA) approved Bayer’s new drug application for Mirena in December 2000.  Today, more than two million women in the United States use Mirena.  It has been used by more than 15 million women worldwide.  The system releases levonorgestrel, a synthetic progestogen directly into the uterus for birth control.  Bayer admits that “it is not known exactly how Mirena works” but provides that Mirena may thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy.

Doctors that implant the Mirena are supposed to check 6-8 weeks after implantation to confirm the device was properly inserted. Many doctors, however, do not perform this step.

The Mirena Intra-Uterine System (IUS) is designed to be placed within seven (7) days of the first menstruation and approved to remain in the uterus for up to five (5) years.  If continued use is desired after five (5) years, the old system must be discarded and a new one inserted.  The package labeling recommends that Mirena be used in women who have at least one child, suggesting that carrying a child to term may be complicated after Mirena’s use.

Mirena’s label does not warn about spontaneous migration of the IUS device but only states that migration may occur if the uterus is perforated during insertion.  Bayer has a history of overstating the efficacy of Mirena while understating the potential safety concerns.  In or around December 2009, Bayer was contacted by the Department of Health and Human Services Division of Drug Marketing, Advertising and Communications regarding a consumer-directed program entitled “Mirena Simple Style Statements Program” a live presentation designed for “busy moms.”  The Simple Style Program was presented in a consumer’s home or other private setting by a representative from “Mom Central” a social networking internet site and Ms. Barb Dehn, a nurse practitioner.  The Simple Style Program represented that Mirena would increase the level of intimacy, romance, and emotional satisfaction between sexual partners.  The Government determined these claims were unsubstantiated and, in fact, pointed out that Mirena’s package insert states that at least five percent (5%) of clinical trial patients reported a decreased libido after use.  The simple style program strip also intimated that Mirena use can help patients “look and feel great.”  Again, the Government noted these claims were unsubstantiated and that Mirena can cause a number of side effects, including weight gain, acne, and breast pain or tenderness.  The portion of the simple style script regarding risks omitted information about serious conditions, including susceptibility to infections and the possibility of miscarriage if a woman becomes pregnant on Mirena.  Bayer falsely claimed that its program required no compliance with a monthly routine.

Lawsuits have been filed on behalf of women who received the Mirena device and who have experienced a spontaneous perforation of the uterine lining / uterine wall by their Mirena IUD / IUS.  It is alleged in lawsuits that have been filed that Bayer placed Mirena into the stream of commerce with wanton and reckless disregard for the public safety.  It is alleged that Bayer knew and, in fact, advertised and promoted the use of Mirena despite their failure to test or otherwise determine the safety and efficacy of such use.  In deed, despite the fact that evidence existed that the use of Mirena was dangerous and likely to place users at serious risk to their health, it is alleged that Bayer failed to disclose and warn of the health hazards and risks associated with the Mirena and in fact acted to deceive the medical community and public at large, including all potential users of Mirena, by promoting it as safe and effective.  It is alleged that Bayer knew or should have known that physicians and other healthcare providers began commonly prescribing the Mirena product as a safe and effective contraceptive device despite its lack of efficacy and potential for serious permanent side effects.

Lawsuits also allege that the Mirena was manufactured, marketed, promoted and sold by Bayer without substantial change in the condition in which it was sold.  The foreseeable risks associated with the Mirena device are alleged to be more dangerous than a reasonably prudent consumer would expect when used in an intended reasonably foreseeable manner.  It is therefore alleged that defendants defectively designed the Mirena device especially considering that the devices are known to spontaneously perforate the uterine wall and cause serious permanent side effects, medical bills, lost work, and otherwise pain and suffering to patients at large.

Lawsuits also allege that Bayer failed to use reasonable care in designing Mirena and that the company failed to properly and thoroughly test Mirena before releasing the drug to the market, failed to properly and thoroughly analyze the data resulting from the pre-marketing test of Mirena, failed to conduct sufficient post-market testing and surveillance of Mirena, designed/manufactured/marketed/advertised/distributed/sold Mirena to consumers without an adequate warning of the significant and dangerous risks, failed to exercise due care, and negligently continued to manufacture and market the device after it knew of adverse effects.

Likewise, it is alleged that the manufacturers of Mirena had a duty to warn consumers and the medical community of the dangers associated with Mirena and by negligently and/or wantonly failing to adequately warn of these dangers breached their duty of care owed to plaintiffs.  It is alleged that a spontaneous perforation of the uterus by a Mirena device can cause severe pain, infections, surgical procedures, medical treatment, and result in the occurrence of medical expenses both past and future.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Mirena: What is the Mirena IUD?

What is Mirena IUD? This is a question many people ask themselves especially if they are checking out the viable birth control options available in the market. Mirena IUD is a long term hormonal intrauterine device that is used for long term contraception or birth control. The acronym IUD stands for Intrauterine Device: It is a T shaped frame wound on a copper wire inserted at the base of the uterus to prevent fertilization. The working mechanism of Mirena hormonal IUD is simple. The device has a circular cylinder that releases low doses of progestin which prevents fertilization. The Mirena IUD increases cervical mucus making it harder for fertilization to occur and it also causes thinning of the lining of the uterus reducing chances of implantation of the fertilized ova.

The use of Mirena IUD has become popular with many women seeking to prevent unwanted pregnancies. The device apart from being effective for up to 5 years after insertion it can be readily removed at any time followed by a quick return to baseline fertility (as long as the device does not become embedded or perforate the uterus). The use of Mirena has also been noted to suppress ovulation while decreasing menstrual bleeding and pains after a short time of use. The other benefit that stands out with Mirena IUD is that it does not have the side effects related to those associated with estrogen based birth control methods.

The use of Mirena IUD is not entirely risk free. Some of the serious risks include: Ectopic pregnancies, expulsion of the IUD and other side effects. Nearly 2% of women using Mirena conceive within the first year of use. If conception is achieved there are high chances of having an implantation of the fertilized egg in the fallopian tubes other than on the uterus wall. This may be because the uterus walls are thinned by use of Mirena. Although this is rare it can occur. Some people can expel Mirena from their uterus due to various conditions: Women who have: never been pregnant, younger than 20 years,  with prolonged menstrual periods and if the insertion was made after birth or abortion. Mirena also does not prevent contraction of STIs.

If you experienced adverse Mirena side effects, required surgery or have a loved one who suffered death following the implantation of Mirena, you may have a potentialMirena lawsuit.

No Recovery, No Fee

We take Mirena litigation cases on a contingency basis. That means that there is no cost to you unless we and our co-counsel are able to recover a settlement or judgment on your behalf. So, unless your case is resolved by trial, arbitration, settlement, or other resolution, you do not have to pay any attorney fees to us, or pay any costs. Litigation costs include filing fees, court reporter fees for deposition, copying costs, experts, and travel. Litigation costs are paid by our firm so you don’t have to have cash to pursue justice against medical device corporations.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Mirena Attorney Says There Are Mirena Problems

Mirena IUD is an FDA approved birth control device that has been marketed widely and become very popular as a birth control method. This device produced by Bayer Inc was approved for contraception use and later as a treatment for heavy and prolonged menstrual bleeding in women who had given birth. The use of Mirena has been noted to have various side effects that have not been in the advertisements to keep users of the device aware of the potential risks. These side effects include ectopic and intrauterine pregnancies, Pelvic inflammatory disease and perforation of uterus, uterine walls or the cervix. Ectopic and intrauterine pregnancies are a dangerous situation in which conception is achieved while using the Mirena IUD and implantation occurs in the fallopian tubes or within the uterus with the IUD in place.

The Mirena IUD has been marketed to women as a great and stress free way to prevent conception. The Bayer Inc promotions dubbed this device as a way to “Look and Feel Great”. Also it was purported to simplify lifestyles and reconnect you with your body and your partner. The validity of these claims have not been certified. The use of this marketing strategy has led to many women choosing IUDs in birth control. Many women have been required to undergo surgery to remove the Mirena device after it perforated the uterus.

It is not possible to know how many women choose Mirena IUD as a contraceptive because of the promises made in promotions and adverts. However it is important that if you or your loved one has suffered uterine injury, ectopic and intrauterine pregnancies or any other serious side effects that can be tied directly to Mirena use, you should contact us to discuss the specific facts of your claim.

Serious side effects that have been linked to Mirena include:

• Abscesses
• Embedment in the uterus
• Erosion of adjacent areas such as the vagina
• Infertility
• Inflammation of the membrane that lines the abdominal cavity and internal organs (Peritonitis)
• Intestinal perforations or obstruction
• Pelvic Inflammatory Disease
• Perforation of the uterus

If you experienced adverse Mirena side effects, required surgery or have a loved one who suffered death following the implantation of Mirena, you may have a potentialMirena lawsuit.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Unnecessary Surgery for Hysterectomy With Mirena

Mirena is alleged to have many side effects. Mirena is an interuterine contraceptive device {IUD}. Our team includes Mirena attorneys that want to provide information to women or their loved ones about making a Mirena claim or to discuss a Mirena lawsuit.

The number of laparoscopic hysterectomy is rising; however, there still are technical problems and disadvantages in the procedure that need further research. In laparoscopic surgical procedures, the surgeon loses direct contact with the surgical site. His vision is restricted. Instead of seeing the entire surgical field including adjacent organs, he can see only the point of surgery, and his view depends on the angle of the camera. The surgeon does not have the tactile feedback of open surgery due to the length of the shaft of the surgical instruments. In addition, the freedom of movement of the video camera and the long-shafted instruments is limited because they are fixed in the abdominal wall. This forces the surgeon into uncomfortable and unnatural body postures affecting the outcome of the operation.

Positions especially when they are static, lead to cramps, muscle pain and rapid fatigue. This can possibly result in an adverse event. Several factors inherent in laparoscopic surgery result in postures that are far from the ideal.

When performing laparoscopic procedures, factors inherent to that type of surgery constrain not only the surgeons’ posture but also their view of the surgical site. Those factors can contribute to error and subsequent adverse outcomes.

The surgical instruments are limited because they can be moved only in certain directions: they can be inserted and removed; moved at an angle about the fulcrum, the point of support at the entry port; rotated about a longitudinal axis as in turning the instrument inside the body cavity; and made to open and close. These limitations restrict the surgeons’ movement of the instruments and frequently force awkward postures of the arms and shoulders, hence can influence the execution of the surgical procedure.

Typically, one thinks of surgical instruments as reusable; however, reusable instruments can be difficult to clean and reassemble after cleaning. Lack of standardization of instruments from different manufacturers sometimes creates difficulties during the operation. Loose working parts on the ends of the instruments such as laparoscopic graspers, an instrument with end-effectors that are expected to grasp tissue, can be ineffective. The surgeon may not be able to identify that problem until the instrument is removed from the abdominal cavity and visually examined, when the loose working parts become obvious.

If you have suffered an injury from a Mirena device, please contact us for help.

Side Effects of Mirena Discussed in More Detail

Some women who have had Mirena implanted experienced serious and even debilitating or life-threatening side-effects. The device may migrate from its original position after being inserted, perforating the uterus or embedding itself in the uterus. In both instances, a doctor must locate and surgically remove the device. Mirena may also migrate outside the uterine cavity and cause adhesions or scarring that can lead to infertility. Depending on the damage caused, affected women may require a complete hysterectomy, and more serious complications could result in death.

Serious side effects that have been linked to Mirena include:

• Abscesses
• Embedment in the uterus
• Erosion of adjacent areas such as the vagina
• Infertility
• Inflammation of the membrane that lines the abdominal cavity and internal organs (Peritonitis)
• Intestinal perforations or obstruction
• Pelvic Inflammatory Disease
• Perforation of the uterus

If you experienced adverse Mirena side effects, required surgery or have a loved one who suffered death following the implantation of Mirena, you may have a potentialMirena lawsuit.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Mirena Injury Lawyer Notes That Mirena Sales Continue to Rise

Bayer’s second quarter report continues to show strong healthcare sales, despite concern over a couple of their products. In fact, Mirena, Bayer’s intra-uterine system (IUS), was the leader in revenue increase for the company. Overall earnings for the company fell, however, due to funds being set aside to handle lawsuits regarding the Yasmin birth control pills. With the growing concern over Mirena, the company may need to be setting aside funds for those lawsuits as well.

Mirena is a device designed to prevent pregnancy. However, there is some uncertainty on exactly how it works. Lawsuits file as recent as July 26, 2012 in New Jersey indicate that not only is the action of the device unclear, it also poses risks that are not presented by Bayer. Bayer does state that the device may migrate if a patient’s uterus is accidentally perforated during insertion of the device. However, plaintiffs claim that spontaneous migration occurs, and the device has been found in other places besides its original intent. Obviously, such migration could cause serious damage to the internal organs.

Cases involve Mirena also claim that the company uses false advertising, marketing the device as a way to help busy moms feel better, without pointing out potential side effects such as breast tenderness, acne, and weight gain: all issues which are reported side effects. These seem to contradict the look good and feel great claims.

Patients who have suffered injury as a result of Mirena should not remain silent. While the company continues to bring in revenues, patients are suffering at the expense of misinformation. If you have experienced harm or side effects as a result of a Mirena insertion instead of the promised positive lifestyle changes, you may be eligible to file a claim against the company. Side effects include uterine wall perforation, pelvic inflammatory disease, ectopic pregnancy, headaches, ovarian cysts, breast tenderness, irregular spotting, and intrauterine pregnancy. If you are facing any of these side effects contact our team of attorneys today for a free consultation. They can help determine what legal recourse you may be eligible for.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Perforation of the Uterus Claims are possible says Mirena Lawyer

The Mirena device is manufactured by Bayer Pharmaceuticals.  Bayer Pharmaceuticals was formerly known as Berlex, Inc. which was formerly known as Berlex Laboratories.  Nevertheless, Bayer is the holder of the new drug application for the contraceptive device Mirena.

Mirena is an intra-uterine contraceptive system made of flexible plastic that is inserted by a healthcare provider during an office visit.  The Federal Food and Drug Administration (FDA) approved Bayer’s new drug application for Mirena in December 2000.  Today, more than two million women in the United States use Mirena.  It has been used by more than 15 million women worldwide.  The system releases levonorgestrel, a synthetic progestogen directly into the uterus for birth control.  Bayer admits that “it is not known exactly how Mirena works” but provides that Mirena may thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy.

The Mirena Intra-Uterine System (IUS) is designed to be placed within seven (7) days of the first menstruation and approved to remain in the uterus for up to five (5) years.  If continued use is desired after five (5) years, the old system must be discarded and a new one inserted.  The package labeling recommends that Mirena be used in women who have at least one child, suggesting that carrying a child to term may be complicated after Mirena’s use.

Mirena’s label does not warn about spontaneous migration of the IUS device but only states that migration may occur if the uterus is perforated during insertion.  Bayer has a history of overstating the efficacy of Mirena while understating the potential safety concerns.  In or around December 2009, Bayer was contacted by the Department of Health and Human Services Division of Drug Marketing, Advertising and Communications regarding a consumer-directed program entitled “Mirena Simple Style Statements Program” a live presentation designed for “busy moms.”  The Simple Style Program was presented in a consumer’s home or other private setting by a representative from “Mom Central” a social networking internet site and Ms. Barb Dehn, a nurse practitioner.  The Simple Style Program represented that Mirena would increase the level of intimacy, romance, and emotional satisfaction between sexual partners.  The Government determined these claims were unsubstantiated and, in fact, pointed out that Mirena’s package insert states that at least five percent (5%) of clinical trial patients reported a decreased libido after use.  The simple style program strip also intimated that Mirena use can help patients “look and feel great.”  Again, the Government noted these claims were unsubstantiated and that Mirena can cause a number of side effects, including weight gain, acne, and breast pain or tenderness.  The portion of the simple style script regarding risks omitted information about serious conditions, including susceptibility to infections and the possibility of miscarriage if a woman becomes pregnant on Mirena.  Bayer falsely claimed that its program required no compliance with a monthly routine.

Lawsuits have been filed on behalf of women who received the Mirena device and who have experienced a spontaneous perforation of the uterine lining / uterine wall by their Mirena IUD / IUS.  It is alleged in lawsuits that have been filed that Bayer placed Mirena into the stream of commerce with wanton and reckless disregard for the public safety.  It is alleged that Bayer knew and, in fact, advertised and promoted the use of Mirena despite their failure to test or otherwise determine the safety and efficacy of such use.  In deed, despite the fact that evidence existed that the use of Mirena was dangerous and likely to place users at serious risk to their health, it is alleged that Bayer failed to disclose and warn of the health hazards and risks associated with the Mirena and in fact acted to deceive the medical community and public at large, including all potential users of Mirena, by promoting it as safe and effective.  It is alleged that Bayer knew or should have known that physicians and other healthcare providers began commonly prescribing the Mirena product as a safe and effective contraceptive device despite its lack of efficacy and potential for serious permanent side effects.

Lawsuits also allege that the Mirena was manufactured, marketed, promoted and sold by Bayer without substantial change in the condition in which it was sold.  The foreseeable risks associated with the Mirena device are alleged to be more dangerous than a reasonably prudent consumer would expect when used in an intended reasonably foreseeable manner.  It is therefore alleged that defendants defectively designed the Mirena device especially considering that the devices are known to spontaneously perforate the uterine wall and cause serious permanent side effects, medical bills, lost work, and otherwise pain and suffering to patients at large.

Lawsuits also allege that Bayer failed to use reasonable care in designing Mirena and that the company failed to properly and thoroughly test Mirena before releasing the drug to the market, failed to properly and thoroughly analyze the data resulting from the pre-marketing test of Mirena, failed to conduct sufficient post-market testing and surveillance of Mirena, designed/manufactured/marketed/advertised/distributed/sold Mirena to consumers without an adequate warning of the significant and dangerous risks, failed to exercise due care, and negligently continued to manufacture and market the device after it knew of adverse effects.

Likewise, it is alleged that the manufacturers of Mirena had a duty to warn consumers and the medical community of the dangers associated with Mirena and by negligently and/or wantonly failing to adequately warn of these dangers breached their duty of care owed to plaintiffs.  It is alleged that a spontaneous perforation of the uterus by a Mirena device can cause severe pain, infections, surgical procedures, medical treatment, and result in the occurrence of medical expenses both past and future.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Lawsuits filed by Mirena Lawyer for Perforation of Uterus

The Mirena device is manufactured by Bayer Pharmaceuticals.  Bayer Pharmaceuticals was formerly known as Berlex, Inc. which was formerly known as Berlex Laboratories.  Nevertheless, Bayer is the holder of the new drug application for the contraceptive device Mirena.

Mirena is an intra-uterine contraceptive system made of flexible plastic that is inserted by a healthcare provider during an office visit.  The Federal Food and Drug Administration (FDA) approved Bayer’s new drug application for Mirena in December 2000.  Today, more than two million women in the United States use Mirena.  It has been used by more than 15 million women worldwide.  The system releases levonorgestrel, a synthetic progestogen directly into the uterus for birth control.  Bayer admits that “it is not known exactly how Mirena works” but provides that Mirena may thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy.

The Mirena Intra-Uterine System (IUS) is designed to be placed within seven (7) days of the first menstruation and approved to remain in the uterus for up to five (5) years.  If continued use is desired after five (5) years, the old system must be discarded and a new one inserted.  The package labeling recommends that Mirena be used in women who have at least one child, suggesting that carrying a child to term may be complicated after Mirena’s use.

Mirena’s label does not warn about spontaneous migration of the IUS device but only states that migration may occur if the uterus is perforated during insertion.  Bayer has a history of overstating the efficacy of Mirena while understating the potential safety concerns.  In or around December 2009, Bayer was contacted by the Department of Health and Human Services Division of Drug Marketing, Advertising and Communications regarding a consumer-directed program entitled “Mirena Simple Style Statements Program” a live presentation designed for “busy moms.”  The Simple Style Program was presented in a consumer’s home or other private setting by a representative from “Mom Central” a social networking internet site and Ms. Barb Dehn, a nurse practitioner.  The Simple Style Program represented that Mirena would increase the level of intimacy, romance, and emotional satisfaction between sexual partners.  The Government determined these claims were unsubstantiated and, in fact, pointed out that Mirena’s package insert states that at least five percent (5%) of clinical trial patients reported a decreased libido after use.  The simple style program strip also intimated that Mirena use can help patients “look and feel great.”  Again, the Government noted these claims were unsubstantiated and that Mirena can cause a number of side effects, including weight gain, acne, and breast pain or tenderness.  The portion of the simple style script regarding risks omitted information about serious conditions, including susceptibility to infections and the possibility of miscarriage if a woman becomes pregnant on Mirena.  Bayer falsely claimed that its program required no compliance with a monthly routine.

Lawsuits have been filed on behalf of women who received the Mirena device and who have experienced a spontaneous perforation of the uterine lining / uterine wall by their Mirena IUD / IUS.  It is alleged in lawsuits that have been filed that Bayer placed Mirena into the stream of commerce with wanton and reckless disregard for the public safety.  It is alleged that Bayer knew and, in fact, advertised and promoted the use of Mirena despite their failure to test or otherwise determine the safety and efficacy of such use.  In deed, despite the fact that evidence existed that the use of Mirena was dangerous and likely to place users at serious risk to their health, it is alleged that Bayer failed to disclose and warn of the health hazards and risks associated with the Mirena and in fact acted to deceive the medical community and public at large, including all potential users of Mirena, by promoting it as safe and effective.  It is alleged that Bayer knew or should have known that physicians and other healthcare providers began commonly prescribing the Mirena product as a safe and effective contraceptive device despite its lack of efficacy and potential for serious permanent side effects.

Lawsuits also allege that the Mirena was manufactured, marketed, promoted and sold by Bayer without substantial change in the condition in which it was sold.  The foreseeable risks associated with the Mirena device are alleged to be more dangerous than a reasonably prudent consumer would expect when used in an intended reasonably foreseeable manner.  It is therefore alleged that defendants defectively designed the Mirena device especially considering that the devices are known to spontaneously perforate the uterine wall and cause serious permanent side effects, medical bills, lost work, and otherwise pain and suffering to patients at large.

Lawsuits also allege that Bayer failed to use reasonable care in designing Mirena and that the company failed to properly and thoroughly test Mirena before releasing the drug to the market, failed to properly and thoroughly analyze the data resulting from the pre-marketing test of Mirena, failed to conduct sufficient post-market testing and surveillance of Mirena, designed/manufactured/marketed/advertised/distributed/sold Mirena to consumers without an adequate warning of the significant and dangerous risks, failed to exercise due care, and negligently continued to manufacture and market the device after it knew of adverse effects.

Likewise, it is alleged that the manufacturers of Mirena had a duty to warn consumers and the medical community of the dangers associated with Mirena and by negligently and/or wantonly failing to adequately warn of these dangers breached their duty of care owed to plaintiffs.  It is alleged that a spontaneous perforation of the uterus by a Mirena device can cause severe pain, infections, surgical procedures, medical treatment, and result in the occurrence of medical expenses both past and future.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

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NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Analysis says many clinical trials are small, have quality issues.

Reuters (5/2, Pittman) reports that an analysis published in the Journal of the American Medical Association indicates that many clinical trials testing drugs and devices are small and the quality is not consistent.

MedPage Today (5/2, Smith) reports that investigators analyzed “the more than 95,000 studies registered since 2004” in the ClinicalTrials.gov database. The researchers found “that the database is dominated by small studies, many conducted at a single center, with significant differences that would make them hard to compare.” The investigators, “for much of the analysis…concentrated on interventional trials in three areas — oncology, cardiology, and mental illness — that included a total of 79,413 studies.”

HealthDay (5/2, Dotinga) reports that altogether, “seven percent of the studies didn’t bother to mention their purpose, while others failed to provide other important details.” The researchers found that “62 percent of the trials from 2007-2010 were small, with 100 or fewer participants.” Just “four percent had more than 1,000 participants.”

Medscape (5/2, Brown) reports, “Mental health trials were more likely than cardiovascular and oncology trials to report use of” data monitoring committees. The researchers found that “oncology trials were least likely to use randomization (64.7% didn’t use randomization, vs 26.2% for cardiovascular trials and 20.8% for mental health trials), and 87.6% of oncology trials were not blinded.”

Unnecessary Surgery for Hysterectomy

Mirena is alleged to have many side effects. Mirena is an interuterine contraceptive device {IUD}. Our team includes Mirena attorneys that want to provide information to women or their loved ones about making a Mirena claim or to discuss a Mirena lawsuit.

The number of laparoscopic hysterectomy is rising; however, there still are technical problems and disadvantages in the procedure that need further research. In laparoscopic surgical procedures, the surgeon loses direct contact with the surgical site. His vision is restricted. Instead of seeing the entire surgical field including adjacent organs, he can see only the point of surgery, and his view depends on the angle of the camera. The surgeon does not have the tactile feedback of open surgery due to the length of the shaft of the surgical instruments. In addition, the freedom of movement of the video camera and the long-shafted instruments is limited because they are fixed in the abdominal wall. This forces the surgeon into uncomfortable and unnatural body postures affecting the outcome of the operation.

Positions especially when they are static, lead to cramps, muscle pain and rapid fatigue. This can possibly result in an adverse event. Several factors inherent in laparoscopic surgery result in postures that are far from the ideal.

When performing laparoscopic procedures, factors inherent to that type of surgery constrain not only the surgeons’ posture but also their view of the surgical site. Those factors can contribute to error and subsequent adverse outcomes.

The surgical instruments are limited because they can be moved only in certain directions: they can be inserted and removed; moved at an angle about the fulcrum, the point of support at the entry port; rotated about a longitudinal axis as in turning the instrument inside the body cavity; and made to open and close. These limitations restrict the surgeons’ movement of the instruments and frequently force awkward postures of the arms and shoulders, hence can influence the execution of the surgical procedure.

Typically, one thinks of surgical instruments as reusable; however, reusable instruments can be difficult to clean and reassemble after cleaning. Lack of standardization of instruments from different manufacturers sometimes creates difficulties during the operation. Loose working parts on the ends of the instruments such as laparoscopic graspers, an instrument with end-effectors that are expected to grasp tissue, can be ineffective. The surgeon may not be able to identify that problem until the instrument is removed from the abdominal cavity and visually examined, when the loose working parts become obvious.

If you have suffered an injury from a Mirena device, please contact us for help.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE MIRENA CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Mirena Lawyer Discusses Unnecessary Surgery for Hysterectomy

Mirena is alleged to have many side effects. Mirena is an interuterine contraceptive device {IUD}. Our team includes Mirena attorneys that want to provide information to women or their loved ones about making a Mirena claim or to discuss a Mirena lawsuit.

The number of laparoscopic hysterectomy is rising; however, there still are technical problems and disadvantages in the procedure that need further research. In laparoscopic surgical procedures, the surgeon loses direct contact with the surgical site. His vision is restricted. Instead of seeing the entire surgical field including adjacent organs, he can see only the point of surgery, and his view depends on the angle of the camera. The surgeon does not have the tactile feedback of open surgery due to the length of the shaft of the surgical instruments. In addition, the freedom of movement of the video camera and the long-shafted instruments is limited because they are fixed in the abdominal wall. This forces the surgeon into uncomfortable and unnatural body postures affecting the outcome of the operation.

Positions especially when they are static, lead to cramps, muscle pain and rapid fatigue. This can possibly result in an adverse event. Several factors inherent in laparoscopic surgery result in postures that are far from the ideal.

When performing laparoscopic procedures, factors inherent to that type of surgery constrain not only the surgeons’ posture but also their view of the surgical site. Those factors can contribute to error and subsequent adverse outcomes.

The surgical instruments are limited because they can be moved only in certain directions: they can be inserted and removed; moved at an angle about the fulcrum, the point of support at the entry port; rotated about a longitudinal axis as in turning the instrument inside the body cavity; and made to open and close. These limitations restrict the surgeons’ movement of the instruments and frequently force awkward postures of the arms and shoulders, hence can influence the execution of the surgical procedure.

Typically, one thinks of surgical instruments as reusable; however, reusable instruments can be difficult to clean and reassemble after cleaning. Lack of standardization of instruments from different manufacturers sometimes creates difficulties during the operation. Loose working parts on the ends of the instruments such as laparoscopic graspers, an instrument with end-effectors that are expected to grasp tissue, can be ineffective. The surgeon may not be able to identify that problem until the instrument is removed from the abdominal cavity and visually examined, when the loose working parts become obvious.

If you have suffered an injury from a Mirena device, please contact us for help.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.