Dangerous Drugs and Medical Devices Marketed to Women, Hurting Women

March 29, 2012 (Press-News.org) Every day we hear about dangerous drugs and medical devices. The U.S. Food and Drug Administration (FDA) routinely reports on investigations, warnings, injuries and recalls. Unfortunately much of the press surrounding these drugs and devices fails to highlight the fact that a growing number of these products are injuring one specific group, women.

Drugs like bisphosphonates, birth control medications as well as devices like transvaginal mesh and metal-on-metal hip implants are created for and/or marketed toward women. All of these products have had ongoing reports of dangerous risks and injuries to the very users they are supposed to be benefitting.

Why is this happening? Each drug and medical device has its own specific set of possible side effects and associated injuries, but there is a common thread underlying all of the products that safety advocates believe may be the reason for the concerning injuries suffered by women users. These products are not being adequately tested for the people they are supposed to be helping.

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:

- Deep Vein Thrombosis
- Stroke and heart attack
- Blood clots
- Pulmonary embolism
- Gallbladder and kidney disease

These complications can have long-term health effects and in some cases, even death may be the result.

Due to the number of complications that have been connected to using drospirenone-containing drugs, the FDA required manufacturers to include the increased risk of blood clots on warning labels and to run corrective advertisements for overstating the drugs' effectiveness in treating hormonal side effects and downplaying dangerous risks of side effects.

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. However, in the U.S., birth control medications containing drospirenone continue to be sold and strongly marketed to women on television. Although studies on the dangers continue, safety advocates fear the FDA's response has been sluggish.

Transvaginal Mesh

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
- Bleeding
- Damage to surrounding organs
- Erosion or protrusion of the mesh
- Pain with intercourse
- Urinary tract infections and problems
- 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.

However, even with known safety risks, complications and warnings, manufacturers continue to sell transvaginal mesh on the market and doctors continue to use this product.

Safety advocates question why the FDA is demanding studies on the product safety instead of its removal from the market and why manufacturers have not been required to make a better product. Transvaginal mesh complications have already been reported for years, and though additional studies have been called for, those harmed do not feel they've seen adequate action to remove a harmful product from the market and to stop additional injury.

According to proponents of removing mesh from the market, if/when, the FDA requires changes in the future, the decision will be based on the past adverse event reports held by manufacturers. It seems likely that these reports could have been accessed years ago and the same conclusion reached with fewer women exposed to a harmful medical device.

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
- Pain
- Blood clots
- Difficulty walking

In addition, smaller statured women are having more failures and problems with this product. Since the metal-on-metal hip replacement system 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. Due to the failure rate of the product and rate of injuries, some DePuy metal-on-metal hip replacement systems have since been recalled.

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 underrepresentation" 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.

Article provided by Rheingold, Valet, Rheingold, McCartney & Giuffra LLP
Visit us at www.rheingoldlaw.com