Manufacturers and Breast Implant Cancer Risks
When women make a choice about what type of breast implant goes inside their body, they need to be sure that they know all of the risks. It is important to note that, in some cases, women may not have a choice. Sadly, mounting evidence shows that a rare form of cancer may be a long-term side effect of breast implants.
Women with breast implants and those considering their options need to be aware of the manufacturers associated with any alleged faulty products.
The first confirmed case of breast implant-associated large cell lymphoma was diagnosed in 1997. Recent research has drawn attention to the textured surface on some breast implant models. It seems that BIA-ALCL develops mostly in women who have (or had) textured breast implants.
Some women with textured implants manufactured by the following companies have been diagnosed with BIA-ALCL:
- Mentor
- Allergan
- Sientra
Some specific products and manufacturers include:
- MemoryGel™ SILTEX silicone breast implants by Mentor (acquired by Johnson & Johnson)
- Natrelle® silicone breast implants by Allergan (acquired by Actavis)
- Opus™ silicone breast implants by Sientra
The World Health Organization (WHO) and governmental agencies, including the U.S. Food and Drug Administration (FDA), have stressed that the total risk factor and the number of women who have been affected are not yet comprehensive. This is largely due to imperfect reporting practices in the U.S. and around the world.
Do Textured Implants Contribute to BIA-ALCL?
Scientists are still determining the exact connection between textured breast implants and ALCL. That said, many researchers believe the development of ALCL in the breast implant is due in part to the reaction between the implant and the body.
Due to their ridges and rough surfaces, textured implants “stick” to tissue inside the body more than do smooth implants. This “texture” serves two purposes. First, it prevents the implant from moving. It also reduces the risk of tissue tightening around the implant in what is known as a capsular contracture.
Both of these outcomes—breast implant movement and capsular contractures—can lead to additional risks. They also happen much more frequently with smooth implants.
What researchers have started to discover, however, is that the properties that make textured implants “stick” may be aiding the development of BIA-ALCL. The larger amount of “rougher” surface area of textured implants contributes toward the growth of “biofilm.” Biofilm is the surface growth of microorganisms. An everyday example of a biofilm is a dental plaque.
Breast implant-associated ALCL is a cancer of the immune system. It causes certain white blood cells, known as T-cells, to rapidly multiply out of control. The current theory is that the microorganisms that make up the biofilm cause a long-term immune system response that can lead to the unregulated growth of T-cells. Some doctors encourage patients to think of it as a “long-term allergic reaction.”
It is also important to note that textured implants account for only 12 percent of all breast implants in the United States. These types of implants are used more commonly in Europe. Due to their higher usage rate in Europe, Allergan (one of several manufacturers that has been linked to cases of BIA-ALCL), in partnership with France’s National Agency for the Safety of Medicines and Health Products, recently halted sales and recalled all unused textured Allergan implants until more information on BIA-ALCL becomes available.
While the FDA has not yet made any such recalls or mandates to halt sales, the recent move in France could signal what is soon to come in the United States.
Types of Cases Women Suffering From BIA-ALCL
While the causes may be different, breast implants have injured many women over the years. In the 1990s, a number of manufacturers were held accountable in a string of lawsuits that demonstrated they had downplayed the risks of breast implants. Instead of being open with women about the potential dangers of their breast implants, they stayed silent.
The question now is: Has history repeated itself? To some experts, the answer to that question is yes—but in a different way.
A new wave of lawsuits alleges that manufacturers failed the women who entrusted them with one of the most delicate areas of their bodies: their breasts.
Current litigation involves manufacturers that may be guilty of:
- Failing to warn: Companies have a duty to adequately warn consumers about the risks and side effects associated with their products.
- Failing to conduct adequate research: Both before and after a product is put on the market, companies have to make sure that it is safe, even over a long period of time.
- Not providing informed consent: People undergoing medical procedures have a right to be adequately informed about the risks and dangers they consent to.
- Selling defective medical devices: Medical devices sold in the U.S. must be free of dangerous defects in design, manufacturing, and marketing.
Though it may sound strange, the FDA classifies breast implants as a type of medical device. Medical devices have always had unforeseen side effects. The FDA deals with this by making sure companies continue to conduct research after the product is on the market. With regards to BIA-ALCL, the lawsuits allege that manufacturers did not follow FDA standards for this aftermarket research.
To protect the women who got breast implants for cosmetic or reconstructive purposes, manufacturers should have diligently reported on the potential dangers of BIA-ALCL. Because manufacturers offered no such warning, many women were robbed of the right to make a fair and informed choice.
Breast Implants Should Not Have Led to Cancer
Just as there are risks with any kind of surgery, medical devices often come with risks for certain side effects. When it comes to getting breast implants, women and their families had no idea that one of the side effects of their new implants could be cancer.
If you have breast implants and have been diagnosed with BIA-ALCL, now is the time to speak up—not just for you, but for all women who deserve accurate warnings about any product they put inside of their bodies.
