A resource for women with Vaginal mesh,  helping women with Mesh complications and assisting with a Urogynecologist and Vaginal Mesh lawyer   We are always  seeking new information for our women of the Vaginal Mesh.

Summary and Overview

Transvaginal Mesh Guidelines Created by AHRQ Ignored by FDA
April 27, 2012 Posted by: Barb Stephens

The vaginal mesh helpline and Vaginal mesh lawyers are happy to see the AHRQ   has released guidelines for Mesh Surgery. Women call daily with severe complications from their  vaginal mesh implant. The FDA has offered nothing. Even with the guidelines the horrors of the Vaginal mesh cannot be denied.From listening to women every day it is becoming obvious that the transvaginal mesh is dangerous. Women nationwide have filed lawsuits against several vaginal mesh manufacturers, including Johnson and Johnson and Boston Scientific. Hundreds of these cases have been consolidated in a multidistrict litigation (MDL) in the West Virginia district court.It appears that many more will be added over the next months yet doctors are still putting the mesh in women. Many women call our helpline just months after their surgery with severe discomfort and complications.

Even before the U.S. Food and Drug Administration (FDA) issued warnings against the continued use of transvaginal mesh in patients suffering from pelvic organ prolapse, another governmental agency set its sights on the faulty medical device.The U.S. Agency for Healthcare Research and Quality (AHRQ), which is a branch of the U.S. Department of Health and Human Services, released guidelines for patients considering having the questionable medical device implanted. The guidelines also remind doctors that transvaginal mesh is a new procedure and should be used with caution.
The agency, formerly known as the Agency for Health Care Policy and Research, is the research arm of health and human services. It acts as a regulatory agency for patient safety organizations. In its guidelines for utilizing transvaginal mesh, the agency recommended that doctors, surgeons and nurses be adequately trained in using the device to fix pelvic prolapse before implanting it.

Pelvic prolapse is known to occur in women who are past menopause and childbearing years or who have had a hysterectomy. Because of weakened muscles, the pelvic organs, including the uterus and rectum, can slip into the vagina and cause a host of problems. Agency for Healthcare Research and Quality

Doctors were using transvaginal mesh to fix the problem, but many now realize the all of the transvaginal mesh devices on the market are modeled after one that is faulty in design. This faulty design results in mesh erosion.

Because of this, thousands of women are suffering from injuries that include bleeding, immense pain and punctured internal organs. Many women are forced to have the mesh removed in an attempt to lead a normal, pain-free life.

The FDA’s response to transvaginal mesh has been shoddy at best. In 2008, the agency downplayed patient’s complaints about the mesh, saying problems with it is rare.

Three years later, the FDA did a rare reversal and said that problems with the device are “not rare.” However, nothing has been done to regulate the faulty devices or the manufacturers.

In the years between the two FDA decisions, the AHRQ came out with its guidelines for patients. The agency said patients need to be aware of several issues:

•     Transvaginal mesh is considered new way to treat pelvic prolapse, thus not proven.
•     Success rates vary.
•     There is little information about long-term use.
•     Serious complications could result from mesh.
•     Little data exists that transvaginal mesh will actually fix a prolapse problem.
•     Patients should undergo thorough pre-operative counseling regarding the limited data that exists about the device.

With the mounting medical evidence showing that transvaginal mesh is dangerous, women nationwide have filed court complaints against several mesh manufacturers, including Johnson and Johnson and Boston Scientific. Hundreds of the cases have been consolidated in a multidistrict litigation (MDL) in a West Virginia district court. Contact the Vaginal Mesh helpline to get the facts, get help locating a Doctor for Mesh removal and be connected to an experienced vaginal mesh , mass tort lawyer.

Lawsuits are being Filed by transvaginal mesh lawyers on behalf of women with vaginal mesh complications. Vaginal mesh helpline Keeps women updated on new news regarding the Vaginal Mesh. According to Lisa Spitzer MSW "we must continue to give women hope that they will obtain justice for ruined lives due to these vaginal mesh complications. The pain and suffering is horrific"

New Lawsuit Filed on Trasvaginal Mesh Serious Complications: the Threat of Severe Adverse Events from Transvaginal Mesh Remains
According to court documents, on April 10th, 2012 an Illinois woman, a Vaginal meshh lawyer , filed a lawsuit in West Virginia Southern District Court (case no. 2:2012cv01025) alleging she suffered a multitude of medical problems as a result of a transvaginal mesh surgery to treat a pelvic organ prolapse (POP). Plaintiff was surgically implanted with the Pelvitex polypropylene vaginal mesh system and she is suing Bard Healthcare, a division of C.R. Bard, Inc., et al for nearly $10 million in damages. Transvaginal surgical mesh is used to treat pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). Several lawsuits against C.R. Bard were consolidated in October 2010 as part of an MDL (No.2187) in the US District Court for the Southern District of West Virginia. Vaginal Mesh helpline can provide helpful, proven advice and simple solutions including how to get in contact a vaginal mesh lawyer so anyone can easily and inexpensively deal with cases of Transvaginal Mesh horrors.

The vaginal mesh Helpline Speaks to women daily regarding their mesh complications and hears many stories. Many are very similiar, inability to have sexual intercourse, severe pain, mesh erosion thru the vaginal wall, spot bleeding, infections, pain on one side of the body,

lower back pain, and Doctors being unsympathetic to the problems they are having. We speak to women from Florida to California and as far north as Canada. "The stories are horrific and women are truly suffering. We are here to help" Says spitzer. 

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

Vaginal mesh helpline has Launched a Yaz Helpline for Women harmed by Yaz. Yaz now has been given orders by The FDA for increased warnings and Bayer si offering the first round of payoffs for yaz. yaz has complications such as: Stroke, blood clots, Deep vein thrombosis, Pulmonary embolism, and even death. At Vaginal mesh Helpline we are concerned about all drugs and medical dsevices harming women and will continue to keep our followers informed about all neew developements. Our research has shown that Yaz was being given out by Planned Parenthood in many states esecially to lower income families as a form of birth control. Wer found comments from the executive director of planned parenthood on Yaz:

d Clot Warning Added To Birth Control Pills Like Yaz: What To Know
10 days ago by Briana Rognlin | 5 Comments | Share a Tip

birth control blood clot warningsThe Food and Drug Administration announced earlier this week that it would add stronger warning labels to Yaz, Yasmin and other birth control pills containing drospirenone (a synthetic version of the hormone progesterone) about the associated risk of blood clots. But, the FDA emphasized, the risk is still small; smaller, in fact, than the risk of blood clots during pregnancy or the postpartum period, and small enough that women taking the pill shouldn’t worry and should “continue taking their pills as directed unless told otherwise by their healthcare professional.” But headlines like “FDA’s Yasmin and Yaz Blood Clots Warning is a Victory for Consumers” and “The Birth Control Warning You Need To Know About” would make you believe otherwise. So we spoke to Planned Parenthood‘s Vice President of External Medical Affairs, Vanessa Cullins, to find out what we really need to know.

Check out our Q&A with Cullins, who put the risk of popular brands like Yaz, Yasmin, Beyaz, Safyral into perspective for us:

First, can you explain which kinds of birth control are most worrisome?

I want to start out by saying that none of the FDA-approved birth control methods should be considered worrisome. There are risks and benefits to all medications, including prescription birth control. When you look across the board at hormonal-containing birth control pills, whether you’re talking about those that contain drospirenone (like Beyaz, Yasmin or Yaz), or, say, desogestril (like Desogen), all are extremely safe and effective. There are some progestins that carry with them a slightly higher risk of venous thromboembolism—yet venous thromboembulism is still extremely rare and occurs much less often than during pregnancy, childbirth and the postpartum period.

Are there women in particular who are at higher risk?

First of all, if a woman has a history of venous thromoembulism she should not be using hormonal birth control pills that contain estrogen.

But a woman may sit down with her doctor, look at her family history and risk factors in general—for instance perhaps she does a whole lot of plane travel, or has other reasons to be very sedentary, and has never been on a contraceptive formulation in the past—and decide that they want to try a formulation that has a history of a lower risk of venous thromboembulism, such as levonorgestrel. But by the same token, you could have a woman who is on a plane or sedentary a lot, and has been on levonorgestrel formulations in the past and not had a good side effect experience, so she’s willing to accept that increased risk of venal stromboembulism because it’s much more important for her to prevent pregnancy at this point in her life, and she wants to use a pill.

What I’m trying to convey here is that it’s very situational and unique to the circumstances and lifestyle issues of an individual woman. It means taking into account the woman’s individual characteristics as it relates to her medical and family history, and such things as whether or not she’s at an increased risk of venous thromboembulism.

The FDA has said that women should “continue taking their pills as directed unless told otherwise by their healthcare professional.” So why are they requiring the new warning labels?

Because information is a good thing., as long as it is appropriately considered. And by appropriately considered I mean not being alarmed. The information is important in individualizing or tailoring a decision around contraception formulation.

Should women book appointments with their physicians in order to discuss the risks, or just sit back and wait until their next appointment as they normally would?

I would advise women to sit back and wait for their next apointment to discuss this. However if she is extremely worried by all means make a phone call. I think a phone call should be adequate in terms of allowing the physician or health care practitioner to talk about her concerns. If by chance an appointment is needed that can be determined through the phone call.

Is this sort of news damaging for birth control types or brands? Have health warnings on other birth control methods persuaded women to switch?

Unfortunately the reaction generally is one of alarm and both providers and women potentially overreacting and stopping their birth control and this resulting in unintended pregnancy rates going up. This issue is not a new issue: The first time this came about was in 1995 when epidemiological studies in Europe, particularly in Great Britain, showed that pill formulations containing gestodene (which is only available in Europe). And on the basis of the findings being reported in an inappropriate context, you had both providers and women becoming very alarmed and people stopping their preferred birth control formulations and the resulting situation the following year was actually an increase in the abortion rate.

Is there one particular kind of birth control that’s clearly “the safest” or risk free? Is there any sort of dream birth control in that sense?

It depends on what kind of risks you’re looking at. What immediately comes to mind is that when you’re not using anything, then you don’t have any risk associated with mediation or use of that particular thing. So with abstinence you tend to not have medical risks. But you can potentially have some psychological risks…[ed. note: at this point, Cullins and I giggle together over the 'risks' of abstenence] depending on who you are.

I would say that, you know, there are risks associated with anything and everything. Clearly all medications have risk associated with them, and you just have to determine what you’re willing to kind of put up with. Whether you’re talking about side effects or very rare risk.

What do you want to drive home?

I just want to say that decision-making around contraception and women to become pregnant or women to parent is based on risk versus benefits, and what’s important to you and for your family at that particular time in your life. So that risk and benefit balance will change over time. And that’s normal. It’s all about putting things into perspective.

I fyou or a love one has experienced complications form yaz call our new Yaz division today. We will offer you the same TLC as our  lady victims of the horrors of  the vaginal mesh. Ladies we must fight for justice. There are just too many drugs and medical devices harming women.

Ladies, Bayer Pharmaceuticals has annonced a settlement for blood clots form yaz victims. The first round is settling for over $200,000 per claimant. This is good news for all litigations of dangerous drugs and medical devices harming women. Vaginal Mesh helpline has expanded resurces to help women injured by other Drugs and Medical devices. With so many drugs and medical devices harming women we see a need for additional helplines.

The Yaz Helpline sponsored by Vaginal Mesh Helpline and Yaz Lawyers are pleased to announce  Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous Yaz blood clots. The FDA has increased the details of warnings on Yaz labeling to include increased risk of strokes. ladies theis is a good thing and means the Vaginal mesh victims can expect justice when theor turn comes around. Victims of Yaz, It is not too late for you. If you have not filed a claim contact us immediately. Yaz was given out in many states by palnned parenthood to young women for birth control.

Call our new Yaz Yasmin Helpline Speak to a female Social Worker and be connected to a yaz lawyer

Yaz Payoff Complications, Bayer is paying on,

• blood clot,
•  stroke,
•  heart attack,
•  deep vein thrombosis dvt,
•  pulmonary embolism,
•  death,

Safety Announcement
[09-26-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study (See Data Summary), FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.

Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, being overweight (obesity), and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.
Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. FDA previously communicated preliminary information about these concerns to the public on May 31, 2011 .
FDA has prepared a list of questions and answers to provide an overview of this potential safety issue. FDA will continue to communicate any new information to the public as it becomes available
Health Canada is currently reviewing the safety of Bayer Pharmaceutical’s birth control pills, Yaz and Yasmin, in an effort to determine if women who use these drugs are at an increased risk of developing life-threatening blood clots over women using different brands of birth control.

Yaz Lawyers of Free Legal Shield are pleased to  announce that contraceptive Manufacturer, Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous blood clots.

New Warning Labels on Yaz April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots.

Many Studies show Yaz linked to Blood Clots

two new studies recently published in the British Medical Journal, which concluded that women ages 15-44 taking birth control pills containing the synthetic progestin, drospirenone, are more likely to develop blood clots deep in the veins of the leg (venous thromboembolism), than women using birth control pills containing the common progestin levonorgestrel. The studies reported that the risk of developing blood clots for women taking the drospirenone-containing pills may be two to three times greater than those who take other pills. Yaz is one of these drugs.

Yaz New Warnings  April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots

Yaz side effects include:
• Deep vein thrombosis (DVT)
• Pulmonary embolism (PE)
• Blood clots
• Stroke
• Heart attack
• Gallbladder problems
• Pancreatitis
List of Drugs
Approved Oral Contraceptives containing Drospirenone

    Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.03 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
    Zarah Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    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 0.02 mg
    Gianvi Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Loryna Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Yaz Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Recent warnings have linked various birth control drugs and devices to serious injuries and even death:

    Yasmin®
    Yaz®
    Ocella®

Injuries reported:

    Deep Vein Thrombosis
    Pulmonary Embolism
    Stroke
    Heart Attack
    Wrongful Death
    Blood Clot Related Injuries
    Kidney Failure
    Gallbladder Injury/Removal

If you or a loved one has suffered from any of the harmful side effects of Yaz,Yasmin or Ocella such as blood clots, stroke or heart attack you may be entitled to file a Yaz,Yasmin,Ocella lawsuit against the manufacturer. Call us for a yaz lawyer with experience in birth control drug lawsuits toevaluate your claim. Many women around the United States have suffered from life-threatening Yaz,Ocella and Yasmin birth control side effects. The manufacturer can be held liable.
The Woman's Yaz Helpline is here for women suffering from Yasmin and Yaz  and Drospirenone side effects
 

Stronger Warnings

Prior Settlements

Wave of Litigation

Scheduled Trials

At the Vaginal Mesh Helpline we have been contacted by many women whose vaginal mesh case has been rejected by a law firm for many different reasons. Many are inexperienced local lawyers while  others have been rejected for a variety of other reasons. The key factors appear to be lack of confirmation from a physician that the mesh is casuing a problem and that either revision surgery or removeal is needed. Well ladies ,you know when you have symptoms. However, many doctors are not willing to say that the mesh is causing a problem or women do not have funds to go to a doctor. Call the vaginal mesh helpline to be connected to a law fim  and get a second opinion. Do not give up hope . You must seek justice.

FDA Adverse reporting Guidelines
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the following information in your reports, if available:

Documenting this type of information will be extremely helpful when you contact a lawyer as well. The FDA guidlines are an excellent record keeping formate to follow.

•     Manufacturer's name
•     Product name (brand name)
•     Catalog number
•     Lot number
•     Size
•                               Your Lawyer Will Want to Know
•     Date of implant
•     Date of explant (if mesh was removed)  (Important)
•     Details of the adverse event and medical and/or surgical interventions ( Important )
•  
•     Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
•     Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
•     Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
•     Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment

Vaginal mesh failure symptoms

Complications of the Vaginal Mesh include:

• Failure of the Procedure
• Pain (Vagina, leg, pelvic, adbominal)
• rejection of the graft material
• chronic continuous relentless infections
• the need for constant antibiotics
• patch bleeding
• lower back pain
• pain on one side of the body
• painful sexual intercourse
• partner feeling the mesh
• constant bleeding or spotting
• Recurrent urinary tract infection
• Extrusion of the mesh into the vagina causing pain, discharge, bleeding
• Erosion of the mesh into bowel, bladder, urethra, or rectum

For medical Support

Contact a local University Hospital Dept of Urogynecology

or the American Association of Urogynecology

or see the states and resource pages on vaginalmeshhelpline.com

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.

 

 

 

Legislators are seeking to regulate the approval process for vaginal mesh and similar medical devices.

A Massachusetts lawmaker has introduced a new bill which would allow for stricter regulation of the medical device approval process. The bill specifically  targets    Vaginel mesh Device which have become the target of numerous lawsuits filed on behalf of women who say these products caused serious health complications.

At a press conference Thursday morning, Rep. Ed Markey (D-Mass.) introduced the new bill, called the Safety of Untested and New Devices (SOUND) Act. The new legislation would allow the U.S. Food and Drug Administration (FDA) to require manufacturers of medical devices based on existing products that have known safety issues to provide documentation showing that the new product’s design has eliminated potential flaws.

Representative Markey introduced the new bill in the hopes that it would be incorporated into a larger bill that Congress is set to vote on at the end of May. The larger bill, while aimed at increasing FDA oversight of the medical device approval process, does not contain specific wording that would currently close an existing loophole, known as the 510(k) rule. Under the 510(k) guidelines, a medical device  manufacturer may seek approval of a device without conducting additional safety testing if it can prove that the device is substantially similar to a product that is already on the market, regardless of whether the existing product has any known safety issues.

Thus far, the bill has yet to gain any Republican support. While the FDA has acknowledged the need for a Congressional measure to help close the existing 510(k) loophole, the agency has not issued any official statement lending to support to the larger bill already before Congress or the new SOUND Act. Earlier this month, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, spoke out against the loophole, saying it challenges the credibility of the medical device approval process.

The FDA approves an average of 28 devices per year using the 510(k) guidelines. Statistically, a new device is five times as likely to be recalled if its design is based on an older device that has known safety issues. This is the case for the Johnson & Johnson Ethicon Gynecare vaginal mesh system, which was based on an existing mesh product manufactured by Boston Scientific. That product, the ProtoGen mesh system, was recalled shortly after the Ethicon mesh gained approval. Now, the Ethicon Gynecare system, along with vaginal mesh devices manufactured by Boston Scientific, American Medical Systems and C.R. Bard are the subject of numerous lawsuits filed on behalf of women who say these devices caused severe pain, swelling, tissue damage, blood vessel damage, bladder and bowel perforation and other complications. The vaginal mesh helpline hears from women on a daily basis regarding their vaginal mesh complications. Women are suffering, lives have been dramatically altered. Someting must be done. Doctors are still implanting these mesh devices even after the 2008 warning. The stories are horrific and our callers seek justice.