Breast implantation is a relatively common medical procedure in which saline or silicone prostheses are implanted into the breast as part of cosmetic or restorative breast surgery. Approximately 8 percent of all American women have undergone breast implant surgery, accounting for well over two million citizens. Nearly all of these patients are Caucasian, with only 5 percent of all breast implant recipients indicating a race other than white. The majority of breast implantation procedures are performed as a form of cosmetic surgery to enhance breast size. Many patients recovering from breast cancer undergo breast implant surgery following a mastectomy in order to restore symmetry and reconstruct the breast. Other individuals seek breast implantation due to injuries, genetic defects, or gender reassignment surgery.
Defects in Breast Implants
While the vast majority of breast implants are perfectly safe, there have been many reports in the last decade of defective implants that have caused significant injury to patients. Some of the most common defects found in faulty breast implants include prostheses that rupture very easily or implants that are filled with contaminated silicone or saline. In other cases, breast implants have been released into the market with incorrect model numbers, causing incorrect prostheses to be implanted in patients. Unfortunately, the dangers posed by some implants do not come to light until a particular prosthetic has been on the market for many years and implanted in a high number of patients.
Ever since the first silicone implants appeared on the market in the 1960s, the Food and Drug Administration (FDA) has gone to great lengths to keep the public informed and protected from the dangers posed by defective breast implants. The FDA provides extensive information on recalls and possible risks on their Website. Additionally, the FDA now requires manufacturers of silicone-based breast implants to conduct 10-year studies on women who have already received the silicone implants in order to ensure the safety of all silicone prostheses manufactured after 2006. Previously, silicone implants had been under a 14-year ban by the federal government due to the proven risk of the silicone implants leaking or rupturing.
Injuries Caused by Defective Breast Implants
Despite FDA regulations, defective breast implants find their way into the market every year, and a patient can be seriously injured if a defective breast implant ruptures or otherwise fails. Some of the more serious injuries caused by defective breast implants include toxic shock and gangrene. On some occasions, defective breast implants have been found to rupture during routine mammograms. A particularly alarming danger of defective breast implants is presented by implants that have been discovered to leak saline or silicone into the breast milk of nursing mothers. More common complications arising from defective breast implants include breast hardness and pain.
Silicone Implant Defects Cover-up
One of the more important cases involving defective breast implants involved select models of silicone implants manufactured by the Mentor Corporation. According to a 2005 article in the New York Times, former employees of the company provided sworn testimony during a deposition that indicated that the company was aware of dangerous defects in some of their breast implants and went to great lengths to conceal this information from the FDA, the medical community, and patients who had been implanted with the prostheses. The testimonies were provided as part of the plaintiff’s argument that complications caused by a defective breast implant had made her gravely ill. The FDA executed a comprehensive investigation into allegations of falsified documents and contaminated silicone that was closed in 2002 with the determination that no wrongdoing had occurred.
Following the discovery of the cover-up of thousands of ruptured implants with contaminated silicone during the late 1980s and early 1990s, the FDA chose to allow the Mentor Corporation to renew their manufacturing of silicone implants in 2006. Independent consumer protection groups and other advocacy groups such as the National Organization for Women often cite the complicated history between silicone breast implant manufacturers, the public, and the FDA when making the argument that silicone implants were allowed back on the market before it was proven that they presented an acceptable risk to patient health.
In December 2005, the California-based manufacturer of breast implants Inamed Corporation issued a voluntary recall of two different models of Style 468 Breasts and Style 163 Breasts due to a mistake that had occurred at the manufacturing plant, resulting in the items being shipped with incorrect labels. The recall was issued in time to avoid any unfortunate accidents or injuries to patients.
Sources:
- http://www.nytimes.com/2005/05/22/national/22implant.html
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43348
- http://www.surgeryencyclopedia.com/A-Ce/Breast-Implants.html
- http://www.mindfully.org/Health/Breast-Implant-Risks-FDA.htm
PIP Breast Implant Recall
On March 30, 2010, France’s health regulators issued a recall of all pre-filled silicone breast implants manufactured by Poly Implant Prothese (PIP), a company based in southern France. The breast implant recall is said to affect an estimated 35,000 to 45,000 women worldwide.
AFSSAPS, the health regulatory agency of France, discovered an unauthorized type of silicone gel being used in the pre-filled implants. Following the recall, the French court ordered the company to shut down entirely for the manufacturing of fraudulent implants.
The recalled PIP implants have been associated with abnormally high rupture rates, as well as a higher incidence of local inflammatory reactions.
Unauthorized gel used in pre-filled silicone implants can damage the coating of breast implants and allow the shell to leak more easily and cause unwanted complications.
“Clinicians should not implant these devices and they should quarantine any stock,” said Dr. Susanne Ludgate from the Medicines and Healthcare products Regulatory Agency (MHRA). “Patients who have concerns about their PIP silicone gel-filled breast implants should contact their breast implant surgeon.”