There are so many dangerous drugs and medical device Harming women that the Breast Implant Helpline Has composed an overview for our readers.
Dangerous Drugs and Medical Devices Hurting Women are growing in number .Our Womens health lawyers Take Notice
The Female Medical Social Worker at our Womens Health helpline devision is concerned about the huge number of dangerous drugs andmedical devices hurting women
Drugs like bisphosphonates, Yaz, Yasmin, as well as devices like transvaginal mesh and metal-on-metal hip implants or the Mirena Silicone IUD are marketed toward women. All of these products have had ongoing reports of dangerous risks and injuries to women users with additional warnings being added weekly.
Just this week it was announced that Birth control settlement: Drug maker Bayer will pay at least $110 million to settle about 500 lawsuits over claims that its Yasmin line of birth control pills caused blood clots, Bloomberg reports. Additional lawsuits are expected. The FDA this week ordered stronger blood clot warnings on the current version of Bayer's pill, Yaz, and similar drugs.
Many of these products are not being adequately tested for the people they are supposed to be helping. They are being pushed thru on the FDA fast track which approves drugs and devices if the manufacturer can prove it is substantially similiar to a drug or device already approved. This seems tp apply more readily to devices although it can happen with drugs as well.
Although they are made for women, many of these medical products are not designed for women or tested on women before flooding the market. As a result, poorly designed products, many with known complications, are readily available for unsuspecting women.
Another issue is that although serious injuries have been reported by users, the FDA has been slow to act and require a change by manufacturers. In the meantime, product manufacturers have been able to reap financial benefits at the expense of women’s health and safety.
Products Dangerous to Women
Of the growing number of unsafe drugs and medical devices hurting women, certain products have an increasing number of reported risks and injuries.
Birth Control – Yaz, Yasmin
Yaz and Yasmin are two popular birth control medications that contain drospirenone, a manmade hormone that imitates the effects of progesterone. The pills inhibit ovulation and thus prevent pregnancy. When the product was initially made available to the public, it was very popular due to marketing highlighting its ability to clear up acne and lessen other hormonal side effects. Bayer is responsible for the Yaz line of birth control and had slick marketing campaigns while downplaying any evidence that it had a higher percentage of side effects than many other birth control pills. In fact, Bayer has been repeatedly admonished by the FDA for misleading advertisements and, more recently, watered down warnings.
However, label warnings failed to caution women and prescribing doctors of the dangerous risks and potential side effects associated with using the drug. Drospirenone-containing birth control medications, such as Yaz, Yasmin Ocella, Beyaz, Gianvi, Zarah, Loryna and Seyda have an increased risk of side effects such as:
- Gallbladder and kidney disease
- Blood Clots
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Cerebrovascular Accidents (CVA)
- Heart Attack
- Myocardial Infarction
These complications can have long-term health effects and in some cases, even death may be the result.
On April 10, 2012, the FDA announced it was requiring a label change for drugs such as Yaz which contain the chemical drospirenone, warning that the chemical may be associated with a higher risk for blood clots.
According to an April 13, 2012 Bloomberg article, Yaz is still the fourth most popular oral contraceptive, earning Bayer over $1.5 billion in 2010 with prescriptions to millions of women.
Several studies have indicated the blood clots associated with the drug may be linked to an increased risk of stroke, deep vein thrombosis and pulmonary embolism injuries to the lungs.
In 2009, The British Medical Journal published research from Denmark and the Netherlands linking the chemical drospirenone in Yaz to an increased risk of blood clots, a contributing factor for stroke.
In October, 2011, the FDA released a study of more than 800,000 women taking oral contraceptives which showed that those taking drugs like Yaz had a 74% increased risk of developing blood clots.Numerous studies have also been conducted on the safety of birth control pills, like Yaz and Yasmin. In fact, the results of two studies published in the British Journal of Medicine revealed that women taking these types of birth control medications were 2-3 times more likely to develop blood clots than women taking other types of birth control drugs. Drug labels in Europe require this type of warning information and knowledge of the associated dangers is widespread among European doctors..
Transvaginal mesh is a medical device used to repair pelvic organ prolapse or damaged tissue from stress urinary incontinence. The mesh product itself was originally used as, or substantially similar to, a hernia product already on the market.
Mesh was not specifically designed for vaginal use. Unlike mesh used to repair hernias, vaginal mesh is used on internal organs that are moving and flexing. When the mesh stays rigid, complications occur, such as metal erosion and infection.
According to a 2011 FDA report, some of the most commonly reported complication risks include:
- Pelvic pain
- Infections in tissue surrounding the mesh
- perforation of the bladder and bowel
- Damage to surrounding organs
- Erosion or protrusion of the mesh
- Pain with intercourse
- incessant Urinary tract infections
- Vaginal scarring or shrinkage
- Recurrent prolapsed
For many women who experience these painful complications, additional corrective surgeries are needed. The growing number of reported injuries has lead to concern by medical professionals, FDA safety alerts to manufactures and ongoing safety investigations.
For more information on the vaginal mesh see vaginalmeshhelpline.com
Bisphosphonate Drugs – Fosamax, Boniva, Actonel
Bisphosphonate drugs, such as Fosamax, Boniva, Actonel, Reclast and Atelvia, are used to treat symptoms of bone degeneration like osteoporosis. Though intended to treat bone disease, ironically, users of the drugs are at risk of bone damage. Namely, bisphosphonate side effects include femur fractures and osteonecrosis of the jaw (damage to the jaw bone). Though drugs like Fosamax, Boniva and Actonel can be used by men or women, older female users most often suffer from painful side effects.
Due to the risk of bone injury, the FDA has required bisphosphonate drug labels to include warnings of the increased risk of fractures. In addition, the agency is continuing to study the effects of long-term bisphosphonate medication use. The drugs are marketed for lifelong use, however, clinical data does not support use after 3-5 years. As a result, medication labels must also include the uncertainty surrounding long-term drug use and its effectiveness.
Metal-on-Metal Hip Implants
Metal-on-metal hip replacement implants are used to replace a diseased hip joint with an artificial joint in order to increase motion, relieve pain and help a patient get back to day-to-day activities. In metal-on-metal devices, both the hip ball and socket are made of metal and intended to be long-lasting. The devices also contain a larger hip ball to provide stability. Unfortunately, the size and nature of the metal-on-metal product, like DePuy’s ASR Acetabular Cup System, also carries an increased risk of dangerous side effects.
Some side effects of metal-on-metal hip replacement devices include:
- Blood metal poisoning (metallosis)
- Soft tissue damage
- Bone loss
- Blood clots
- Difficulty walking
In addition, smaller stature women are having more failures and problems with this product. Since the metal on metal hip replacement was designed with a larger ball and cup, it doesn’t work on a smaller framed person. As a result, a disproportionate number of women are being injured. Orthopedic experts believe that inadequate testing and a fatal product flaw have contributed to the serious injuries suffered by patients who have received the metal-on-metal hip implant. Researchers at Bristol University reviewed patient data for approximately 400,000 individuals who underwent hip replacement surgery between 2003 and 2011. Of the 400,000 patients studied, approximately 31,000 were fitted with a metal hip device. The researchers found that among patients with a metal hip, approximately 6.2% required additional revision surgery within five years of undergoing the hip replacement. The revision rate for patients with ceramic-on-ceramic implants was 2.3% and 1.7% for patients whose implants featured a metal-on-plastic construction. The researchers also found that women who had an all-metal hip were up to four times more likely to require corrective surgery versus men who had one of these devices. Specifically, the risk for failure was greatest among women who had a larger femoral head implant. see depuyhipreplacementhelpline.com
FDA Response to Product Injuries
The FDA has taken notice of the disparity in gender-specific testing and gender-specific products. The agency has urged drug and device manufacturers to correct the “historical under representation” of women in clinical trials and studies, as reported by Bloomberg. Certain drugs and devices will react differently when used by women simply because of genetics, such as body frame, mass and hormones, stated the FDA. When manufacturers fail to test products on a proportionate sampling of females, particularly in products intended for use by women, the results are not representative. Nor do safety advocates believe they can adequately account for potential risks and side effects. For these reasons, the FDA released guidelines for manufacturers that addressed how to conduct gender-specific clinical testing, analysis and reporting for product studies.
While further FDA required studies and safety investigations take place, many of these dangerous medical drugs and devices are still available on the market. If you are a woman who has been injured by a medical product, it is important to speak with an attorney experienced in drugs and medical device injury matters. A lawyer can review your case and ensure your legal rights and remedies are being protected.
Breast Implant Helpline in conjunction with Vaginalmeshhelpline.com Depuyhipreplacementhelpline.com and classactionlawyernetwork.com has launched a joint effort to protect and help women who are victims of dangerous drugs and medical devices. Call our helplines today.
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