Posts Tagged ‘Long Island’

Pelvic Mesh Helpline, Pelvic Mesh Lawyers, Pelvic Mesh Lawsuit

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

The Pelvic Mesh Helpline is here to help you.

Our pelvic mesh medical social worker can help you understand your mesh complications and how to get a vaginal mesh doctor. We can also offer help in connecting with a pelvic mesh lawyer. The Pelvic  Mesh Helpline is connecting women with pelvic mesh lawyers and doctors nationwide. Let us help you locate a pelvic mesh lawyer. Pelvic mesh go under many names: They could be called a vaginal mesh, bladder sling, vaginal tape, TVT, pelvic mesh, or surgical mesh. This is still a vaginal mesh.

Manufacturers Involved In the Pelvic Mesh Lawsuits

Johnson & Johnson, Ethicon TVT Gynecare, TVT Gynemesh, PS Prolene Polypropylene Mesh, Patch Secur Bard Avaulta Plus™ BioSynthetic Support System Avaulta Solo TM, Synthetic Support System Faslata®, Allograft Pelvicol® ,Tissue PelviSoft®, Biomesh Pelvitex™, Polypropylene Mesh American Medical Systems or AMS SPARC®, Boston Scientific Advantage™, Sling System Obtryx®, Curved Single Obtryx®, Mesh Sling Prefyx Mid U™, Mesh Sling System Prefyx PPS™

Many women who have suffered injuries as a result of pelvic  mesh have decided to file  pelvic mesh lawsuits. This has become a Multi-District Litigation and lawsuits are being consolidated and filed in selected districts thru-out the USA.  Pelvic Mesh Helpline lawyers are accepting nationwide cases on an individual basis, not as part of a class action.

 

Pelvic Mesh Multi District Lawsuit List Consolidated Under Judge Goodwin in West Virginia

 

Pelvic Mesh Lawsuit MDL – 2325, IN RE: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation

Pelvic Mesh Lawsuit MDL – 2326 IN RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation

Pelvic Mesh Lawsuit MDL – 2327 IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation

Pelvic mesh lawsuit MDL – 2387 IN RE: Coloplast Corp. Pelvic Support Systems Products Liability Litigation

What are the Pelvic Mesh Lawsuit  Complications ?

  • Erosion of the pelvic mesh thru the vaginal wall
  • Pelvic Mesh Failure
  • Infection is a serious mesh-patch complication
  • Pain and discomfort
  • Perforations of the bowel, bladder or blood vessels
  • Recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
  • Urinary problems and more severe incontinence
  • Painful sexual intercourse
  • Potential injury to the partner
  • Feeling the mesh or pieces of substance in the vaginal canal
  • Vaginal mesh erosion
  • Increased incontinence
  • Lower back pain
  • Abdominal pain
  • Gastrointesitnal discomfort
  • Bladder and or bowel incontinence

 

 

 

 

 

Vaginal Mesh Lawyers Filing Nationwide Vaginal Mesh Lawsuits

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

Vaginal Mesh helpline, vaginal mesh lawyers are filing lawsuits for women injured by the vaginal mesh. If you have been rejected due to the statute of limitations or other criteria call the Vaginal Mesh Helpline to speak to one of our experienced mesh lawyers today.

The vaginal mesh lawsuit bellwether trials have begun and the mesh lawsuits are heating up. You must file your mesh lawsuit immediately.

What are the Transvaginal Mesh Complications ?

  • Erosion of vaginal tissue can result from a vaginal mesh
  • Hardening of the vaginal mesh
  • Infection is a serious mesh-patch complication
  • Pain and discomfort
  • Perforations of the bowel, bladder or blood vessels
  • Recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
  • Urinary problems and more severe incontinence
  • Painful sexual intercourse
  • Potential injury to the partner
  • Feeling the mesh or pieces of substance in the vaginal canal
  • Vaginal mesh erosion
  • Increased incontinence
  • Lower back pain
  • Abdominal pain
  • Gastrointesitnal discomfort
  • Bladder and or bowel incontinence
  • Difficulty voiding and the need for self catherizations
  • Vaginal scarring

Vaginal Mesh Lawsuits Are  Against These Manufacturers

  • C.R. Bard’s Avaulta
  • Ethicon’s Gynecare
  • American Medical Systems’ products:
  • AMS Apogee
  • AMS BioArc
  • AMS Elvate
  • In-Fast Unltra
  • MiniArc
  • Monarc
  • AMS Perigee
  • SPARC
  • Straight-In mesh
  • Boston Scientific Scimmed’s Pinnacle pelvic mesh
  • Covidien
  • Sofradim
  • Caldera
  • Mentor Corporation

To file a vaginal mesh lawsuit call us today.

 

Yaz Birth Control Pills Lawyers, New April 2012 Warning Date, Yaz Lawyers Filing Yaz Lawsuits

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Information

The VaginaL Mesh Helpline is keeping women updated on all dangerous drugs and devices harming women. Many women were injured by Yaz  birth control pills and thought that they were out of luck in filing a Yaz lawsuit. Yaz complications  include: Blood clots, stroke, pulmonary embolism, deep vein thrombosis and in some instances death. Many women with complications and families that have lost loved ones due to Yaz felt they could not file a lawsuit. But, new warnings issued in April pf 2012 has opened doors for an influx of Yaz lawsuits. We do not want you to be left out.

The FDA Ordered  Warning Label Changes For  Yaz Blood Clots

The FDA announced it was requiring a label change for  Yaz

On April 10, 2012, the FDA announced it was requiring a label change for Yaz which contains Drospirenone. This warning   announced that Yaz may be associated with a higher risk for blood clots due to Drospirenone. This warning date may mean you now have a Yaz lawsuit even though you may have been turned away before.

Yaz  Lawsuit Complications

  • Blood Clot
  • Stroke
  • Pulmonary embolism
  • Deep Vein Thrombosis

Blood clots from Yaz may be linked to an increased risk of stroke, deep vein thrombosis and pulmonary embolism injuries to the lungs.

A federal Multi-District Litigation court in Illinois set up to handle lawsuits filed over alleged Yaz side effects has reported more than 10,000 cases filed. The formal case is known as Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100).

Yaz lawsuit lawyers are accepting lawsuits from women who have have suffered these  side effects after taking Yaz. Yaz blood clots have caused premature death in young women. This is another medical product that targets women. Women must stand up and demand justice.

Stryker Hip Replacement Effects Women More, Stryker Hip Replacement Lawyers For Women

Written by Vaginal Mesh Helpline on . Posted in Stryker Hip Replacment lawyer for Women, Vaginal Mesh News

The Vaginal Mesh Helpline continues it it’s mission to inform about all dangerous drugs and devices harming women. It appears that even the recent hip replacement recalls effect women more then men. When will women stop being the target of these manufacturers? The vaginal mesh has caused severe injury. Just today we received a call from a woman about her mother of 76 who must wear a colostomy bag after mesh removal. And now the FDA reports that these metal on metal and metal component hip implants  put women at a higher risk. Both the Stryker Rejuvinate and ABG II are  dangerous surgical implants that have a greater failure rate and complications for women.

Many articles and reports have been released that discuss hip replacements having a greater failure rate in women.

Hip replacements like Stryker Rejuvinate and ABG II are slightly more likely to fail in women than in men, according to research published Monday in JAMA Internal Medicine.  The research was financed by the Food and Drug Administration. Another report discusses hip resurfacing and states a drawback for women because of the bone weakening that accompanies menopause. Meanwhile, even advocates of resurfacing acknowledge that they have yet to agree on how best to screen women for the procedure.

“We were surprised by the results, as studies suggest that larger heads should have  lower wear and a lower risk of dislocation. However, we have seen an increase in revisions for pain and loosening, particularly in women,” says Alison Smith, a study author and statistician at the University of Bristol in the U.K. Depending on patient age and implant head size, the revision rate for all-metal hips is three to four times higher in women and two to three times higher in men compared with other implants.

The FDA Reports Women At a Higher Risk For Failure

The Food and Drug Administration, along with its safety communication, has included a list of risk factors that can increase a patient’s chances of suffering from metal on metal hip implant complications. Patients who are overweight, female, or physically active are more likely to suffer complications related to these hip replacement systems, and patients who have a sensitivity to certain metals, have kidney failure, have a suppressed immune system, or take corticosteroids are also more at risk.

It seems women are always the victims for these manufacturers that choose profits over warnings.

Hip Replacement Failure More Likely In Women, Study Says Studies on Google News Today

Hip replacements are more likely to fail in women than in men, but the overall risk of implant failure is low–according to a study published in the Journal of the American Medical Association, JAMA, and that was funded by the U.S. Food and Drug Administration.

Women account for the majority of the more than 400,000 patients who undergo either full or partial hip replacements in the U.S. each year.

“This is the first step in what has to be a much longer-term research strategy to figure out why women have worse experiences,” said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families.

It appears the smaller frame and difference in the curve of the hip and pelvic region accounts for this. Anatomy appears to play a role.  Women tend to have smaller joints and bones than men, and so they tend to need smaller artificial hips. Devices with smaller femoral heads  the ball-shaped part of the ball-and-socket joint in an artificial hip are more likely to dislocate and require a surgical repair.

I wonder why there cannot be two types of replacements, one for women and one for men. But, since they are all being recalled it would just mean more injured women. I am sure there would be extensive marketing to hook women in explaining how their lives would remain active and have a better quality. If you or a wife, mother, girlfriend or female loved one has been injured by these hip implants contact us and we will direct you to a Stryker Hip Replacement lawyer.

 

 

 

 

Vaginal Mesh lawyer filing Vaginal Mesh lawsuits, Vaginal Mesh MDL

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

Vaginal Mesh Lawyers are accepting vaginal mesh Lawsuits as part of a multi district litigation. Vaginal mesh helpline Update

Co-Lead Counsel Appointed in Pelvic Mesh MDL

Emma Gonzalez | May 3rd, 2012

In early February 2012, the U.S. Judicial Panel on Multidistrict Litigation centralized all federal  Vaginal mesh complications lawsuits into MDL (multidistrict litigation). The plaintiffs whose cases are involved in the MDL all allege to have suffered from defective vaginal mesh products, which are surgically implanted to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), manufactured and sold by four defendants. Each of the four defendants has been assigned its own MDL, for a total of four federal pelvic mesh MDL consolidations.

Women across the country who have been injured by mesh implants have consulted a transvaginal mesh lawyer to see if their circumstances warrant a vaginal mesh lawsuit.

Cases alleging vaginal mesh complications are consolidated

The four pelvic mesh MDL defendants are American Medical Systems (AMS), Boston Scientific, C.R. Bard and Ethicon/Gynecare. Cases against them have been consolidated into the U.S. District Court for the Western District of West Virginia, with Chief District Judge Joseph R. Goodwin presiding.

All individual cases involved in the pelvic mesh MDL make similar claims, specifically that device manufactures did not perform adequate research on their products, and therefore failed to warn the medical community and consumers of possible complications, which include chronic infection, mesh erosion, and debilitating pain.

MDL assigns transvaginal mesh lawyer to lead counsel

In recent happenings, three transvaginal mesh lawyers were chosen as Coordinating Co-Lead Counsel for the pelvic mesh MDL. Their primary responsibility will be to coordinate individual tasks within the MDL. To do so, they will evaluate their peers to determine which attorneys are best suited to tasks that are common to all four MDLs.

Additionally, two attorneys were assigned as Co-Lead Counsel to each of the MDLs. These transvaginal mesh lawyer teams will speak on behalf of all plaintiffs during the pelvic mesh MDL pretrial proceedings, and will also respond to court inquiries, handle examination of witnesses, and explore settlement options.

Pelvic mesh MDL raises public awareness

Though the pelvic mesh MDLs are divided into four separate consolidations, Judge Goodwin did appoint a Plaintiffs’ Steering Committee. This transvaginal mesh lawyer committee, which is composed of more than 60 attorneys, crosses MDL lines to divide pretrial duties and coordinate discovery of evidence that is common to all cases.

In the meantime, transvaginal mesh lawyers involved in the MDLs expect case numbers to continue growing, since news of consolidated litigation will help inform affected women of the causes for vaginal mesh injuries.

In July 2011, the FDA increased public awareness by issuing a safety warning in regard to vaginal mesh complications, stating that the agency had been unable to find evidence that vaginal mesh devices are more beneficial than similar, less dangerous methods for treating POP.

 
   

 

 

Boston Scientific Class II Mesh Recall, Boston Scientific Vaginal Mesh lawyers

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

Vaginal Mesh Helpline ,Ladies of the Vaginal  Mesh Announcement: If appears that there has been an official recall of one of the Vaginal mesh Implants.

Boston Scientific issued a Class II recall of its Pinnacle pelvic floor repair kit  over the potential for the needle to detach from the mesh during placement. The device may expose patients to unnecessary risk without offering clinical benefit above safer options.

The product is used to treat pelvic organ prolapse, which occurs when internal organ support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagin

See the Fda Notice Below

Class 2 Recall
Pinnacle Pelvic Floor Repair Kit–Anterior/Apical, and Pinnacle Pelvic Floor Repair Kit–Posterior see related information
Date Posted  August 03, 2011
Recall Number  Z-2931-2011
Product  Pinnacle Pelvic Floor Repair Kit–Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit–Posterior STERILE. Boston Scientific, Corp. Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Code Information  Catalog/UPC: M0068317100, Lot: 1ML0072001. Catalog/UPC M0068317050, Lot: 1ML0070801.
Recalling Firm/
Manufacturer  Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, Massachusetts 01752-1234
Consumer Instructions  Contact the recalling firm for information
For Additional Information Contact  Cindy Finney
508-683-4678
Reason for
Recall  The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.
Action  Boston Scientific Corporation sent on May 10, 2011 an "URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED" letter to all affected customers. The letter included; reason for recall, instructions for the quarantine, discontinued use, and return of the devices, and information for Medwatch reporting. The letter also includes a form that is to be faxed to the firm. For information call (508) 683-4678

Yaz Birth Control Pills pay-off, Yaz Lawyers Ready to file

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

Good News  Ladies Perhaps we will see the same with the vaginal mesh lawsuits or even more.

Bayer Said to Pay $110 Million in Yaz Birth-Control Cases

  • Vaginal mesh helpline keeps women informed on all dangerous drugs and medical devices harming women. The $220,000 settlement per case gives hope to our callers suffering from the vaginal mesh. Just like the vaginal mesh women who took  Yaz birth control pills or Yasmin  never imagined that the side effects could harm them as much as they did. But countless women were affected. They suffered many serious injuries that often changed their lives permanently:
  •     Blood clots (deep vein thrombosis or DVT)
  •     Pulmonary embolism
  •     Gallbladder disease
  •     Pancreatitis
  •     Heart attacks
  •     Strokes (both ischemic and hemorrhagic strokes)

Again we say women who have been injured by Yaz must demand justice. If you have had one of the listed complications you must contact our helpline and speak to a Yaz attorney immediately. You still may have a chance. Some states are out of time. Do not wait. If you have been injured by one of the many drugs or medical devices harming women like yaz, Vaginal mesh, Mirena IUD cantact our helpline today.

By Jef Feeley and Margaret Cronin Fisk – Apr 13, 2012 5:48 PM ET

Bayer, Germany’s largest drugmaker, will pay at least $110 million to settle about 500 lawsuits over claims that its Yasmin line of birth-control pills caused blood clots, in the first resolution of cases over the product, people familiar with the agreements said.
Officials of Bayer, based in Leverkusen, Germany, agreed to pay an average of about $220,000 a case to resolve the claims that its Yasmin and Yaz contraceptives caused sometimes fatal clots that can lead to heart attacks and strokes, two people familiar with the settlement said. The people sought anonymity because the accords haven’t been made public.
Bayer fell 2.5 percent in German trading today, and its American depositary receipts dropped 3.8 percent. The settlements came after a federal judge in Illinois postponed a Jan. 9 trial of a suit accusing Bayer and some of its units of misleading women about the health risks of its birth-control pills so a mediator could try to negotiate a settlement.
The case was the first set for trial of more than 11,000 lawsuits over injuries allegedly caused by the drugs.
“Sounds to me like mediation is paying off,” Carl Tobias who teaches product-liability law at the University of Richmond, said in a phone interview. “As a German company, Bayer probably would like to avoid the risks and costs of litigation in U.S. courts. Mediation tends to be a less- expensive way to deal with these kinds of cases.”

Stronger Warnings

The settlements come as the U.S. FDA April 10 ordered Bayer and other contraceptive makers to strengthen the blood-clot warnings on their products.
Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.
Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them the drugmaker’s biggest-selling drugs after Betarson a multiple sclerosis medication. The Yasmin drugs have been the focus of regulators who question their safety.
“Bayer HealthCare confirms that some cases pending in the current YAZ/Yasmin litigation in the U.S. are being settled,” RY a U.S. spokeswoman for the drugmaker, said in an e-mailed statement. She declined to comment on the number of cases settled or the amount of the accords.
Bayer’s American depository receipts, each worth one ordinary share, fell $2.60, or 3.8 percent, to $65.83 in over- the counter trading today. Shares in Germany dropped 1.28 euros, or 2.5 percent, to 50.56 euros.

Prior Settlements

Bayer officials said in a Feb. 28 U.S. Securities and Exchange Commission filing that the drugmaker has settled 70 cases over the Yasmin line of contraceptives.
Those settlements included “terms and conditions which Bayer views to be reasonable,” officials said in the filing. “Bayer will continue to consider the option of settling individual lawsuits in the U.S. on a case-by-case basis.”
The company is expecting additional suits, officials said in the SEC filing Last year, the U.S. FDAwarned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives.
The FDA examined data on more than 835,000 women who took pills containing Drospirenone including Bayer’s Yasmin line of birth-control pills, according to the FDA report.
Bayer’s Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.

Wave of Litigation

Since 2009, the German drugmaker has faced a wave of lawsuits in courts across the U.S. alleging the birth-control pills caused sometimes fatal blood clots. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008.
Lawyers for former Yaz users contend in court filings that Bayer officials sought to market the contraceptive fgor unapproved uses and misled women about the drug’s health risks
The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in St Louis for pretrial proceedings.

Scheduled Trials

Herndon scheduled a series of trials for early this year so juries could begin weighing claims that Bayer and its units marketed Yaz and other contraceptives as safer than rivals’ products while knowing they posed a higher clot risk.
At Bayer’s suggestion, Herndon called in Stephen Saltzburg, a George Washington University law professor, to serve as a mediator. Saltzburg’s job was to explore the possibility of “settlements in this litigation,” Herndon said in a December 2011 order. The judge put the trial schedule on hold while Saltzburg met with lawyers for the drugmakers and former Yaz users.
Among the lawyers settling Yaz cases as a result of Saltzburg’s efforts are Mark Robinson Chris Seeger and Michael Berg the people familiar with the accords said.
Those three lawyers are serving on the so-called plaintiffs steering committee in the cases before Herndon, according to court filings That group helps decide how the consolidated cases should progress through the litigation process.
Burg, a Denver-based plaintiffs’ lawyer who handles product-liability cases, also is listed in court filings as co- lead plaintiffs’ counsel in the Yaz cases. He declined to comment on the settlements in a interview today.
Seeger, based in New York, and Robinson, a Los Angeles- based attorney, didn’t immediately return calls seeking comment on the settlement.
The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).
Call the Yaz Women's helpline today

 

Blood Clots,Birth Control Pills Containing Drospirenone, Lawyers Accepting Cases

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

The Vaginal Mesh Helpline is keeping women updated on all drugs and medical devices effecting women.Womens health lawyers division is watching all implants, drugs and medical devices that harm women. FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.We are posting this announcement to keep women informed of the risks. If you are effected by this warning andhave had these complications please contsac our helpline to be connected to a lawyer. We are horrified at the number of drugs and medical devices that are harming women. Vaginal Mesh, Mirena IUD, Yaz, Yasmine and others are harming women nationwide. We must seek justice.

On April 10, 2012, the U.S. Food and Drug Administration (FDA) announced a label change for drospirenone-containing birth control pills, such as Yaz and Yasmin, to include the increased risk for developing dangerous blood clots.

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11:  Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.

Safety Announcement

[4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin.  Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.  See Table 1 for a list of drospirenone-containing products.

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.  The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots.  For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.

The revised drug labels (Beyaz, Safyral, Yasmin ,Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.

Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; for women who use birth control pills; for pregnant women; and for women in the postpartum period.  For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot.

Figure 1: Likelihood of Developing a Blood Clot

Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; who use birth control pills; and for women in the postpartum period
COC = combination oral contraceptives or birth control pills

These studies were discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.

Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011.  The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins.  Previously published studies had reported conflicting findings.  The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives.  The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.

Today's communication is in keeping with FDA's commitment to inform the public about the Agency's ongoing safety review of drugs.  FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.

Table 1. Approved Oral Contraceptives Containing Drospirenone

  • Beyaz
  • Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
  • Drospirenone and ethinyl estradiol
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Drospirenone and ethinyl estradiol
  • Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Gianvi
  • Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Loryna
  • Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Ocella
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Safyral
  • Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
  • Syeda
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Yasmin
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Yaz
  • Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Zarah
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg

    Updated External Questions and Answers – Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots

    4-10-2012

    Beyaz Label

    4-10-2012

    Safyral Label

    Yasmin Label

    4-10-2012

    Yaz Label

    FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone

    9-26-2011

    FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone

    10-27-2011

    FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone

    5-31-2011

    FDA Briefing Information for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 1.86MB) (PDF – 5.2MB)

    FDA Drug Safety Podcast for Healthcare Professionals: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

Vaginal Mesh Helpline Announces new helpline for women harmed by these birth contol pills.

Breast Implant Recall In n Europe Shows Us FDA Approval Rate Should Not be Accelerated

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

The vaginal mesh complications in U.S have hurt 100's of women. This may be the largest mass dangrous product to date. Women call the helpline with hoorific stories on a daily basis. The FDA must not accelorate the approval process of Medical devices. The latest recall of breast implantas in Europe is a message that should be listened to.

New York, NY (PRWEB) January 24, 2012 Over the past year, proponents of an accelerated process for procuring FDA approval of high-risk medical devices have been citing the European Union’s process for approving medical devices as a model plan, aJanuary 19 Bloomberg Article states. The EU’s approval process–which allows complex medical devices to reach the European market an average of two years sooner than they reach the U.S. market–is luring device manufacturers away and is consequently contributing to the country’s high unemployment rate, medical device industry supporters argue.

The breast implant debacle in Europe, which involves the removal of thousands of potentially faulty implants manufactured by the now-defunct French company Poly Implants Protheses SA, has heightened scrutiny of the EU’s medical device approval process, however. The European breast implant problem therefore should make U.S. regulators realize that it would be unwise to adopt an accelerated medical device approval process similar to the one in place in Europe, according Carl Heneghan, an Oxford University teacher who has studied device recalls and is cited in the Bloomberg article.

“All the industry guys in the U.S. say, ‘we should have access to these products much sooner, like in Europe,’” the Bloomberg article quotes Heneghan as saying. “The flip side is, the European people are being used as guinea pigs.”

The importance of subjecting medical devices to comprehensive FDA reviews before those devices are approved for sale has been highlighted in recent months by the thousands of U.S. women who have suffered injuries as a result of vaginal mesh implants. Categorized by the FDA as medical devices that the agency can clear for sale based on similarity to medical devices already on the market and without the benefit of human testing, the implants have so far spawned more than 650 lawsuits filed by patients alleging that they have been significantly injured as a result of having mesh products implanted transvaginally. Articles on abc news and on local news explain the FDA approval process that cleared vaginal mesh for sale, and the tribulations of women who are suffering injuries as a result of vaginal mesh and are filing lawsuits to recover for those injuries. Women must be protected for these drugs and medical devices

About Pelvic Prolapse, Vaginal Mesh, Transvaginal Mesh Helpline

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Information

About Pelvic Prolapse, Vaginal Mesh Helpline

The uterus is held in position by pelvic muscles, ligaments and other tissues. If the uterus drops out of its normal position, this is called prolapse. Prolapse is defined as a body part falling or slipping out of position. Prolapse happens when the pelvic muscles and connective tissues weaken. The uterus can slip to the extent that it drops partially into the vagina and creates a noticeable lump or bulge. This is called incomplete prolapse. Complete prolapse occurs when the uterus slips to such a degree that some uterine tissue is outside the vagina.

Pelvic prolapse is usually accompanied by some degree of vaginal vault prolapse. Vaginal vault prolapse occurs when the upper part of the vagina loses its shape and sags into the vaginal canal or outside the vagina. Pelvic prolapse may also involve sagging or slipping of other pelvic organs, including the bladder, the urethra which is the tube next to the vagina that allows urine to leave your body, and rectum.

Normanat and Proluterus
Anatomy of the Vagina

The vaginal vault is the “ceiling” or the inner, upper end of the vagina. The vaginal vault has four “compartments”: an anterior compartment, closest to the front of the body; the vaginal wall; a middle compartment consisting of the cervix; and a posterior compartment consisting of the vaginal wall at the back of the body.
Signs & Symptoms1

Women with mild cases of pelvic prolapse may have no noticeable symptoms. However, as the uterus falls further out of position, it can place pressure on other pelvic organs—such as the bladder or bowel — causing a variety of symptoms, including:

  •     Sensation of sitting on a small ball
  •     Heaviness or pulling in the pelvis
  •     Pelvic or abdominal pain 
  •     Pain during intercourse
  •     Protrusion of tissue from the opening of the vagina
  •     Repeated bladder infections
  •     Vaginal bleeding or an unusual or excessive discharge
  •     Constipation
  •     Frequent urination or an urgent need to empty your bladder 

Symptoms may worsen with prolonged standing or walking due to added pressure placed on the pelvic muscles by gravity.
Causes and Risk Factors1

Pelvic prolapse is fairly common and the risk of developing the condition increases with age. It can occur in women who have had one or more vaginal births. Normal aging and lack of estrogen after menopause may also cause pelvic prolapse. Chronic coughing, heavy lifting and obesity increase the pressure on the pelvic floor and may contribute to the condition. Although rare, pelvic prolapse can also be caused by a pelvic tumor. Chronic constipation and the pushing associated with it can worsen pelvic prolapse.
Screening & Diagnosis1

Diagnosing pelvic prolapse requires a pelvic examination usually performed by a gynecologist. The doctor will ask about your medical history and perform a complete pelvic examination to check for signs of pelvic prolapse. You may be examined while lying down and standing. Imaging tests, such as ultrasound or magnetic resonance imaging (MRI), may be performed to further evaluate the pelvic prolapse.
Treatment1

Treatment is not necessary unless the symptoms are bothersome. Most women seek treatment by the time the uterus drops to the opening of the vagina. Losing weight, stopping smoking and getting proper treatment for contributing medical problems, such as lung disease, may slow the progression of pelvic prolapse.

If you have very mild pelvic prolapse – without any symptoms – or very mild symptoms, treatment is usually unnecessary. However, keep in mind that without treatment, you may continue to lose uterine support, which could cause more severe symptoms.

While clinical studies support the effectiveness of the da Vinci Surgical System when used in minimally invasive surgery, individual results may vary. There are no guarantees of outcome. All surgeries involve the risk of major complications. Before you decide on surgery, discuss treatment options with your doctor. Understanding the risks of each treatment can help you make the best decision for your individual situation. Surgery with the da Vinci Surgical System may not be appropriate for every individual; it may not be applicable to your condition. Always ask your doctor about all treatment options, as well as their risks and benefits. Only your doctor can determine whether da Vinci Surgery is appropriate for your situation. The clinical information and opinions, including any inaccuracies expressed in this material by patients or doctors about da Vinci Surgery, are not necessarily those of Intuitive Surgical, Inc. and should not be considered as substitute for medical advice provided by your doctor. © 2010 Intuitive Surgical. All rights reserved.

    Uterine Prolapse; A service of the U.S. National Library of Medicine – National Institutes of Health. Available from: http://www.nlm.nih.gov/medlineplus/ency/article/001508.htm

Content provided by Intuitive Surgical. For more information, please visit www.davincisurgery.com

PN 874293 Rev A 12/10 U 6-30-11

Practis, Inc. Powered by Encounter Health™ | Terms of Use

The Vaginal Mesh Helpline receives calls daily from women with Vaginal mesh complications. If you are having complications with your mesh device see a Urogyneciologist or your Doctor. Lawsuits are underway against the manufacturers of the vaginal mesh devices. The Vaginal Mesh Helpline can help you locate a Transvaginal Mesh lawyer who will take your case on an individual basis. These cases are contingency cases.