Patient Questions

QUESTION

Can Leaking Silicone Implants Cause Problems in Your Joints?

My silicone implants are leeking and I'm having a lot of problems with my joints (my knees, shoulders, ankles, hips). I was told it was from the silicone going thru my body.

ANSWER

Silicone appears safe but there are things you should know.

Good question June -

Implants were first introduced in 1962 and there have been over 250 types have been created. The Food and Drug Administration has been regulating medical devices in 1976. You are probably aware of the media spectacle regarding implants in the 1980’s when allegations that silicone gel implants could be linked to cancer, autoimmune and connective tissue disorders (such as lupus). Numerous lawsuits were filed and millions of dollars were paid to settle the resultant lawsuits.

Admist these problems, the FDA requested more stringent safety data. There was a lack of this safety data and the FDA banned the general use of gel implants for augmentation, with the exception of women who required breast reconstruction subsequent to breast cancer and mastectomy.

Fourteen years after the ban, in 2006, studies by the Mentor company in which 1007 women were followed for 3 years (with MRI results 1 and 2 years after implantation) and similar studies by Allergan (601 women were followed for 4 years) were deemed adequate to demonstrate safety and the FDA gave a qualified approval for silicone gel implant use. There were several other studies which also looked at the overall safety of silicone in the body.

Interestingly several studies discovered that the highest level of silicone exposure and silicone within the body came from diabetics. Silicone coated needles used for insulin injection over years likely create significantly higher silicone concentrations than implants.

Silicone is likely safe but here are things you should know.

  • The implants will not last forever. They are devices that may need to be replaced.
  • If the implants are removed the breasts will not return to their original shape and may look worse than before. (In other words scars and the changes from implant placement are permanent.)
  • When the implants are replaced there is a higher risk of complications compared to the first time.
  • Mammograms may be more difficult to read and may require additional views or other modalities (CT or MRI).
  • There are on-going studies regarding newer silicone implants. Mentor and Allergan are providing on-going follow-up of the initial women who participated in the core studies for 10 years and also provide a separate 10 year post-approval study on approximately 40,000 silicone implant patients and a control group of women with saline implants.
  • Silicone implants are difficult to detect rupture or leaks and MRI exams starting 3 years after implantation and every 2 years thereafter are recommended for surveillance.

As always, you should discuss these issues with a board certified plastic surgeon. Implants that are leaking should be removed however based on the science we have they are not likely contributing to your symptoms.

I hope this helps.

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