FDA Clears Continued Use of Breast Implants, Despite Complications

Silicone gel breast implants will remain on the market even though at least one in five patients require removal of the devices within 10 years and many develop complications, such as scarring or hardening of the breasts.

As The Wall Street Journal reports, a new analysis by the Food and Drug Administration didn’t reveal any unexpected safety concerns about the implants but cited “frequent local complications and adverse outcomes.” The agency said women who have the devices should get regular screenings for ruptures or other possible problems.

“The benefits and risks of breast implants are sufficiently well understood for women to make well informed decisions about their use,” the FDA said in its report. The analysis was based largely on studies by the implants’ manufacturers, Allergan Inc. and Johnson & Johnson’s Mentor Worldwide unit.

The analysis showed that 20 percent to 40 percent of women receiving implants for augmentation required additional surgery within eight to 10 years. For women who received implants for breast reconstruction, including post-mastectomy, the figure was 40 percent to 70 percent.

One of the most prevalent complications is a hardening of the breast around the implant, the FDA found. Other side effects include rupture and gradual leaking of the silicone, as well as scarring, pain and infection.

As The Washington Post noted, silicone breast implants were banned for most U.S. women in 1992 amid concerns that they might be linked to health problems including cancer and rheumatoid arthritis. Class-action lawsuits brought in the 1990s that claimed the implants caused illnesses including lupus, rheumatoid arthritis and scleroderma led to multibillion-dollar settlements with Dow Corning Corp. and other manufacturers even though the contentions never were proved.

In 2006, however, after studies appeared to exonerate the implants, the FDA allowed sales to resume in 2006, despite some protests.

A new warning came this January, when the FDA said that implants might increase the risk of developing a rare form of lymphoma known as anaplastic large cell lymphoma, a cancer of the immune system. This week’s FDA analysis provided no new information on that issue.

Related Post:
Breast Implants Might Raise Risk of a Rare Cancer

 

 

Print Print  

Like what we're doing? We'd appreciate your support.

2 comments to “FDA Clears Continued Use of Breast Implants, Despite Complications”

  1. FaithfulServant

    Silicone is not safe! Take a look at the TMJ Implant Disaster, the penile implant, the warnings on silastic(silicone) reactions. Many are allergic to silicone and metal debris caused by failed implants. If we continue to let Medical Companies and Manufacturers the right to decieve us then we all become fools to evil, with no rights for the patient.
    With Flawed Research, kickbacks, and no accountability why bother to regulate at all! We pay for research, higher medical costs because of poor doctors, manufacturers and drug companies getting away with murder, and many from the FDA who contienue to let these abuses continue and government wants to handle our medical insurance? No thank you…and what catagory do TMJ Implant survivors fit into? No one wants to claim us! We can only be truly informed if we have honest and truthful research so we can make a wise decision, after all we are the end consumer!
    Love Never Fails…. http://www.youtube.com/watch?v=8nQy-aP_Koo

  2. James

    @FaithfulServant… silicone is not “100% safe” – same with all the products we consume. It depends on the user on how and why she will use implants. If a person would like to have an elective procedure (penile implants) then he must know the consequences and complications he may acquire from such. You should also think of those women who would like to have implants because they need it.

Leave a comment